Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04848220
Status:
TERMINATED
Last Update Posted:
2023-12-12
First Post:
2021-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C544126', 'term': 'APD791'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated early due to a business decision that was not due to any safety concerns. The number of participants was smaller than originally planned and only summary statistics were therefore generated for primary and secondary outcome measures.'}}, 'adverseEventsModule': {'timeFrame': 'From start of study treatment on Day 1 to up to maximum of 10 days', 'description': 'Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Congestive hepatopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vascular access site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'seriousEvents': [{'term': 'Vascular access site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra v24.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Medra v24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.1783', 'spread': '15.35531', 'groupId': 'OG000'}, {'value': '0.0691', 'spread': '13.27702', 'groupId': 'OG001'}, {'value': '-1.8907', 'spread': '18.82659', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'IMR was defined as the mean distal pressure at maximum hyperemia multiplied by the mean hyperemic transit time. IMRcorr (IMR corrected for the influence from collateral supply) was calculated using the following equation, to account for the presence of significant epicardial stenosis without the need for balloon dilation to measure the coronary wedge pressure (Pw), IMRcorr = mean aortic pressure at maximum hyperemia (Pa)\\*mean transit time at maximal hyperemia (Tmn) \\* \\[1.34 \\* mean distal coronary pressure at maximum hyperemia (Pd)/Pa minus 0.32\\].', 'unitOfMeasure': 'Millimeter of mercury*seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants, irrespective of whether they received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2744', 'spread': '0.89307', 'groupId': 'OG000'}, {'value': '1.0238', 'spread': '2.97729', 'groupId': 'OG001'}, {'value': '1.3787', 'spread': '1.40440', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'The coronary flow reserve (CFR) was calculated from the ratio of baseline (i.e., resting transit time) to hyperemic mean transit time.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants, irrespective of whether they received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1346', 'spread': '0.19620', 'groupId': 'OG000'}, {'value': '0.2494', 'spread': '0.20758', 'groupId': 'OG001'}, {'value': '0.3123', 'spread': '0.16562', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'The FFR was calculated from the ratio of distal to proximal mean pressures at maximal hyperemia (FFR = \\[distal coronary pressure/aortic pressure at maximum hyperemia\\]).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants, irrespective of whether they received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.54', 'spread': '7.365', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '6.320', 'groupId': 'OG001'}, {'value': '-8.93', 'spread': '8.368', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'The cTFC is a quantitative index of coronary flow and was calculated based upon the number of cine-frames that the intracoronary dye required to reach distal coronary landmarks.', 'unitOfMeasure': 'Frames per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants in the FAS who received any study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Baseline Grade 3', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '0 to 15 min post-PCI Grade 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': '0 to 15 min post-PCI missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1', 'description': 'The TFG is a measure of epicardial perfusion and was graded on a standard scale from 0 to 3, where Grade 0=no perfusion, grade 1=penetration without perfusion, grade 2=partial perfusion and grade 3= complete perfusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Baseline TMPG value 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline TMPG value 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '0 to 15 min post-PCI TMPG value 3', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '0 to 15 min post-PCI Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1', 'description': 'The TMPG (also known as myocardial blush grade \\[MBG\\]), is a measure of myocardial perfusion in the capillary bed at the tissues level following contrast injection into the coronary artery. TMPG was graded on a scale from 0 to 3, where grade 0 = failure of dye to enter the microvasculature; grade 1 = dye slowly enters but fails to exit the microvasculature; grade 2 = delayed entry and exit of dye from the microvasculature; grade 3= normal entry and exit of dye from the microvasculature.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-PCI for Creatine Kinase (CK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': '0 to 15 minutes post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.7', 'spread': '11.25', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '5.68', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '10.58', 'groupId': 'OG002'}]}]}, {'title': '6 hours post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '17.20', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '27.07', 'groupId': 'OG001'}, {'value': '-23.5', 'spread': '41.03', 'groupId': 'OG002'}]}]}, {'title': '24 hours post- PCI/discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-33.7', 'spread': '23.42', 'groupId': 'OG000'}, {'value': '233.0', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated for only one participant.', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '38.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Set included all participants in the FAS who received any study treatment. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': '0 to 15 minutes Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.290', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.225', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.490', 'groupId': 'OG002'}]}]}, {'title': '6 Hours Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '1.260', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '2.208', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '1.359', 'groupId': 'OG002'}]}]}, {'title': '24 Hours Post- PCI/Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.804', 'groupId': 'OG000'}, {'value': '31.80', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated for only one participant.', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.643', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge', 'unitOfMeasure': 'Micrograms per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Set included all participants in the FAS who received any study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Post-PCI for Cardiac Troponin I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': '0 to 15 minutes Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.126', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.052', 'groupId': 'OG002'}]}]}, {'title': '6 Hours Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '1.310', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.354', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.204', 'groupId': 'OG002'}]}]}, {'title': '24 Hours Post- PCI/Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.197', 'groupId': 'OG000'}, {'value': '5.50', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated for only one participant.', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.300', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge', 'unitOfMeasure': 'Microgram per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Set included all participants in the FAS who received any study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Procedural Myocardial Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': '6 Hours Post-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '24 Hours Post-PCI/Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 6 hours and 24 hours post-PCI/discharge on Day 1', 'description': 'Procedural myocardial injury was defined as elevation of cardiac troponin (cTn) values greater than (\\>) 99th percentile upper reference limit (URL) in participants with normal baseline values (\\<= 99th percentile URL) or elevation of cTn by \\> 20% of the baseline value in participants with elevated cTn levels (\\>99th percentile URL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here 'Number Analyzed' indicates number of participants evaluable at the specified timepoints."}, {'type': 'SECONDARY', 'title': 'Concentration of Temanogrel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Pre-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1558.3889', 'spread': '2156.89423', 'groupId': 'OG000'}, {'value': '1869.8571', 'spread': '1815.65878', 'groupId': 'OG001'}]}]}, {'title': '0 to 15 minutes post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '126.9900', 'spread': '31.08320', 'groupId': 'OG000'}, {'value': '265.0000', 'spread': '109.83260', 'groupId': 'OG001'}]}]}, {'title': '1 hour post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.8667', 'spread': '24.45278', 'groupId': 'OG000'}, {'value': '134.1667', 'spread': '36.56455', 'groupId': 'OG001'}]}]}, {'title': '3 hours post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.8500', 'spread': '17.23969', 'groupId': 'OG000'}, {'value': '87.1714', 'spread': '90.12348', 'groupId': 'OG001'}]}]}, {'title': '6 hours post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.6522', 'spread': '19.78224', 'groupId': 'OG000'}, {'value': '36.9000', 'spread': '14.94380', 'groupId': 'OG001'}]}]}, {'title': '24 hours post-procedure/discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not calculated as all values were below the limit of detection.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge', 'description': 'Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL).', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) set included all participants in the Safety Set with at least 1 post dose PK measurement. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Concentration of AR295980', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Pre-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0472', 'spread': '0.87240', 'groupId': 'OG000'}, {'value': '3.2010', 'spread': '3.97562', 'groupId': 'OG001'}]}]}, {'title': '0 to 15 minutes post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3680', 'spread': '2.61560', 'groupId': 'OG000'}, {'value': '6.8183', 'spread': '2.24211', 'groupId': 'OG001'}]}]}, {'title': '1 hour post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0750', 'spread': '1.81783', 'groupId': 'OG000'}, {'value': '8.0783', 'spread': '4.32397', 'groupId': 'OG001'}]}]}, {'title': '3 hours post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6933', 'spread': '1.18230', 'groupId': 'OG000'}, {'value': '5.5300', 'spread': '2.48489', 'groupId': 'OG001'}]}]}, {'title': '6 hours post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4678', 'spread': '0.79325', 'groupId': 'OG000'}, {'value': '5.2650', 'spread': '3.21979', 'groupId': 'OG001'}]}]}, {'title': '24 hours post-PCI/discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3518', 'spread': '0.40765', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge', 'description': 'Observed plasma concentration of AR295980.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK set will include all participants in the Safety Set with at least 1 post dose PK measurement. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Concentration of AR295981', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Pre-PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8042', 'spread': '1.11941', 'groupId': 'OG000'}, {'value': '5.9129', 'spread': '8.69909', 'groupId': 'OG001'}]}]}, {'title': '0 to 15 minutes post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9032', 'spread': '0.46521', 'groupId': 'OG000'}, {'value': '1.9030', 'spread': '1.05032', 'groupId': 'OG001'}]}]}, {'title': '1 hour post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6743', 'spread': '0.36798', 'groupId': 'OG000'}, {'value': '1.6575', 'spread': '0.73395', 'groupId': 'OG001'}]}]}, {'title': '3 hours post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4677', 'spread': '0.37748', 'groupId': 'OG000'}, {'value': '1.0651', 'spread': '0.32193', 'groupId': 'OG001'}]}]}, {'title': '6 hours post PCI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2899', 'spread': '0.35198', 'groupId': 'OG000'}, {'value': '0.8685', 'spread': '0.51239', 'groupId': 'OG001'}]}]}, {'title': '24 hours post-PCI/discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data were not calculated as all values were below the limit of detection.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge', 'description': 'Observed plasma concentration of AR295981.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK set included all participants in the Safety Set with at least 1 post dose PK measurement. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable at the specified timepoints. Combined data for Stage A and Stage B is presented as pre-specified in protocol."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 or higher TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment on day 1 to up to maximum of 10 days', 'description': 'An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 as grade 1: mild; grade 2: moderate; grade 3: severe, grade 4: life threatening, grade 5: death related to AE. Number of participants with any TEAE and grade 3 or higher TEAE have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Adverse events leading to discontinuation of study treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-Related TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment on day 1 to up to maximum of 10 days', 'description': "An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. Relatedness was based on investigator's assessment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Related TEAEs According to the Preferred Term', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'classes': [{'title': 'Vascular access site haematoma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment on day 1 to up to maximum of 10 days', 'description': "An adverse event was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. Relatedness was based on investigator's assessment.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants in the FAS who received any study treatment. Combined data for Stage A and Stage B is presented as pre-specified in protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'FG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Unable to proceed to study procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Fractional flow not significant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in two stages: Stage A (an ascending single dose study consisting of 2 cohorts of 20 and 40 milligram \\[mg\\] doses of temanogrel or placebo) and Stage B: parallel group study (consisting of 3 treatment groups of temanogrel 20 mg, temanogrel 40 mg and placebo). The study was terminated early due to business decision. Analysis of stage A and B was combined as pre specified in the protocol.', 'preAssignmentDetails': 'A total of 29 participants were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Temanogrel 20 mg', 'description': 'Participants received a single intravenous (IV) dose of temanogrel 20 mg on Day 1 following which the participants underwent percutaneous coronary intervention (PCI). Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'BG001', 'title': 'Temanogrel 40 mg', 'description': 'Participants received a single IV dose of temanogrel 40mg on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received a single IV dose of placebo on Day 1 following which the participants underwent PCI. Participants had a follow-up phone call 7 days after administration of study treatment.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '7.81', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '3.27', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '9.63', 'groupId': 'BG002'}, {'value': '64.6', 'spread': '7.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants, irrespective of whether they received any study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-17', 'size': 1823006, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-18T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2021-04-14', 'resultsFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-23', 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Index of Microcirculatory Resistance (IMR) From Baseline to Post Percutaneous Coronary Intervention (PCI)', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'IMR was defined as the mean distal pressure at maximum hyperemia multiplied by the mean hyperemic transit time. IMRcorr (IMR corrected for the influence from collateral supply) was calculated using the following equation, to account for the presence of significant epicardial stenosis without the need for balloon dilation to measure the coronary wedge pressure (Pw), IMRcorr = mean aortic pressure at maximum hyperemia (Pa)\\*mean transit time at maximal hyperemia (Tmn) \\* \\[1.34 \\* mean distal coronary pressure at maximum hyperemia (Pd)/Pa minus 0.32\\].'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Post-PCI for Coronary Flow Reserve (CFR)', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'The coronary flow reserve (CFR) was calculated from the ratio of baseline (i.e., resting transit time) to hyperemic mean transit time.'}, {'measure': 'Change From Baseline to Post-PCI for Fractional Flow Reserve (FFR)', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'The FFR was calculated from the ratio of distal to proximal mean pressures at maximal hyperemia (FFR = \\[distal coronary pressure/aortic pressure at maximum hyperemia\\]).'}, {'measure': 'Change From Baseline to Post-PCI for Corrected Thrombolysis in Myocardial Infarction Frame Count (cTFC)', 'timeFrame': 'From Baseline (prior to administration of study treatment) to 15 minutes post-PCI on Day 1', 'description': 'The cTFC is a quantitative index of coronary flow and was calculated based upon the number of cine-frames that the intracoronary dye required to reach distal coronary landmarks.'}, {'measure': 'Number of Participants According to Change From Baseline to Post-PCI for Thrombolysis in Myocardial Infarction (TIMI) Flow Grade (TFG) Post-PCI', 'timeFrame': 'Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1', 'description': 'The TFG is a measure of epicardial perfusion and was graded on a standard scale from 0 to 3, where Grade 0=no perfusion, grade 1=penetration without perfusion, grade 2=partial perfusion and grade 3= complete perfusion.'}, {'measure': 'Number of Participants According to Change From Baseline to Post-PCI in Thrombolysis in Myocardial Infarction Myocardial Perfusion Grade (TMPG) Post-PCI', 'timeFrame': 'Baseline (prior to administration of study treatment) and anytime between 0 to 15 minutes post-PCI on Day 1', 'description': 'The TMPG (also known as myocardial blush grade \\[MBG\\]), is a measure of myocardial perfusion in the capillary bed at the tissues level following contrast injection into the coronary artery. TMPG was graded on a scale from 0 to 3, where grade 0 = failure of dye to enter the microvasculature; grade 1 = dye slowly enters but fails to exit the microvasculature; grade 2 = delayed entry and exit of dye from the microvasculature; grade 3= normal entry and exit of dye from the microvasculature.'}, {'measure': 'Change From Baseline to Post-PCI for Creatine Kinase (CK)', 'timeFrame': 'Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI, and 24 hours post-PCI/discharge'}, {'measure': 'Change From Baseline to Post-PCI for Creatine Kinase-Myocardial Band (CK-MB)', 'timeFrame': 'Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge'}, {'measure': 'Change From Baseline to Post-PCI for Cardiac Troponin I', 'timeFrame': 'Baseline (prior to administration of study treatment), anytime between 0 to 15 minutes, 6 hours post-PCI and 24 hours post-PCI/discharge'}, {'measure': 'Number of Participants With Procedural Myocardial Injury', 'timeFrame': 'At 6 hours and 24 hours post-PCI/discharge on Day 1', 'description': 'Procedural myocardial injury was defined as elevation of cardiac troponin (cTn) values greater than (\\>) 99th percentile upper reference limit (URL) in participants with normal baseline values (\\<= 99th percentile URL) or elevation of cTn by \\> 20% of the baseline value in participants with elevated cTn levels (\\>99th percentile URL).'}, {'measure': 'Concentration of Temanogrel', 'timeFrame': 'Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge', 'description': 'Observed plasma concentration of temanogrel. Lower limit of quantification (LLOQ) of temanogrel was 0.500 nanograms/milliliter (ng/mL).'}, {'measure': 'Concentration of AR295980', 'timeFrame': 'Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge', 'description': 'Observed plasma concentration of AR295980.'}, {'measure': 'Concentration of AR295981', 'timeFrame': 'Pre-PCI, anytime between 0 to 15 minutes,1 hour, 3 hours, 6 hours post-PCI and 24 hours post PCI/discharge', 'description': 'Observed plasma concentration of AR295981.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'timeFrame': 'From start of study treatment on day 1 to up to maximum of 10 days', 'description': 'An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 as grade 1: mild; grade 2: moderate; grade 3: severe, grade 4: life threatening, grade 5: death related to AE. Number of participants with any TEAE and grade 3 or higher TEAE have been reported.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation of Study Treatment and Treatment-Related TEAEs', 'timeFrame': 'From start of study treatment on day 1 to up to maximum of 10 days', 'description': "An AE was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect. Relatedness was based on investigator's assessment."}, {'measure': 'Number of Participants With Treatment-Related TEAEs According to the Preferred Term', 'timeFrame': 'From start of study treatment on day 1 to up to maximum of 10 days', 'description': "An adverse event was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. Relatedness was based on investigator's assessment."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temanogrel', 'Microvascular obstruction', 'APD791', 'Percutaneous coronary intervention', 'MVO', 'PCI'], 'conditions': ['Microvascular Obstruction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=APD791-202', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intravenous temanogrel is a safe and effective treatment for microvascular obstruction (MVO) in adult participants undergoing percutaneous coronary intervention (PCI).', 'detailedDescription': 'This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to be conducted in 2 stages (Stage A and Stage B). Stage A is an ascending single-dose placebo-controlled study planned to consist of 2 cohorts. Stage B is a parallel-treatment group study planned to consist of a placebo group and 2 active treatment groups of temanogrel doses selected based on safety and tolerability data in Stage A.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable angina participants suitable for elective PCI, or participants suitable for PCI for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) who are consistently hemodynamically stable until the time of PCI and have a thrombolysis in myocardial infarction (TIMI) Flow Grade 2 or 3 on the diagnostic angiography\n* Target lesions for PCI must appear suitable for stenting as confirmed on the diagnostic angiography and must satisfy the study criteria regarding lesion size and vessel diameter/type.\n* Females must not be of childbearing potential\n* Males with pregnant or non-pregnant female partners of childbearing potential must agree to using a condom during treatment and for 90 days following treatment\n\nExclusion Criteria:\n\n* Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies during the PCI procedure\n* Any history of stroke, seizure, intracranial bleeding, or intracranial aneurysm\n* Transient ischemic attack within the 6 months prior to Screening\n* History of major trauma, major surgery, and/or clinically significant head injury or hemorrhage within the last 6 months of Screening\n* Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI within the target vessel territory within the last 4 months of Screening'}, 'identificationModule': {'nctId': 'NCT04848220', 'briefTitle': 'A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Effect on Microvascular Obstruction of Temanogrel in Subjects Undergoing Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'APD791-202'}, 'secondaryIdInfos': [{'id': 'C5071002', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage A (Dose Cohort 1) and Stage B (Dose Group 1)', 'interventionNames': ['Drug: Temanogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Stage A (Dose Cohort 2) and Stage B (Dose Group 2)', 'interventionNames': ['Drug: Temanogrel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Temanogrel', 'type': 'DRUG', 'description': 'Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure)', 'armGroupLabels': ['Stage A (Dose Cohort 1) and Stage B (Dose Group 1)', 'Stage A (Dose Cohort 2) and Stage B (Dose Group 2)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1', 'armGroupLabels': ['Stage A (Dose Cohort 1 and Dose Cohort 2) and Stage B (Dose Group 1 and Dose Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822-5201', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Tibor Rubin VA Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto - Cardiac Catheterization Laboratory', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Health - The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '6525 GA', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3079 DZ', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Maasstad Hospital', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'SG1 4AB', 'city': 'Stevenage', 'country': 'United Kingdom', 'facility': 'East and North Hertfordshire NHS Trust Lister Hospital', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Arena is a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}