Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-01-07 @ 3:33 PM
Study NCT ID:
NCT00604695
Status:
COMPLETED
Last Update Posted:
2012-09-07
First Post:
2008-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mgibson@perfuse.org', 'phone': '617-632-7753', 'title': 'C. Michael Gibson, MS, MD', 'organization': "Brigham & Women's Hospital"}, 'certainAgreement': {'otherDetails': 'Principal Investigator shall furnish Sponsor with copy of any proposed publication for review/comment prior to submission for publication, at least thirty (30) days prior to submission for manuscripts and at least fifteen (15) days prior to submission for abstracts. Institution agrees to delete information identified by Sponsor as Confidential Information prior to submission for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This pilot study was not adequately powered to exclude a modest increase in bleeding events. Study drug could not be administered to 4 patients and 7 patients were excluded for not meeting the inclusion criteria of TIMI Flow Grade 0/1 at enrollment.'}}, 'adverseEventsModule': {'timeFrame': '30-days following primary percutaneous coronary intervention', 'description': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'eventGroups': [{'id': 'EG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase', 'otherNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline', 'otherNumAtRisk': 16, 'otherNumAffected': 11, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anemia', 'notes': 'Pre-existing anemia.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Ventricular Tachycardia', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Pancreatitis', 'notes': 'Pre-existing chronic pancreatitis.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Incision site pain', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Clostridium difficile infection', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Right hand and finger numbness', 'notes': 'Primary percutaneous coronary intervention was performed via radial approach.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Right groin cellulitis', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Urinary tract infection', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Wheezing', 'notes': 'Pre-existing asthma.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Allergic reaction to Bactrim', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Allergic reaction to Lisinopril', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Bleeding', 'notes': 'Bleeding at the site of insertion of catheter.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hypotension', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Chest pain', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Back pain', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'High grade Atrio-Ventricular Block', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'seriousEvents': [{'term': 'Erosive Gastritis', 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': "Dressler's syndrome", 'notes': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Death', 'notes': 'Cause of death unknown.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '100', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention', 'unitOfMeasure': 'Percent diameter stenosis', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'description': 'Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the treatment arm, 4 patients did not meet the inclusion criteria of Thrombolysis In Myocardial Infarction (TIMI) Flow Grade(TFG) 0/1.\n\nOf the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1.'}, {'type': 'SECONDARY', 'title': 'Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '33'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'description': 'Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery', 'unitOfMeasure': 'Corrected TIMI Frame Count (cTFC)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'description': 'Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients in treatment arm, 4 did not meet the inclusion criteria of TIMI Flow Grade(TFG) 0/1 and cTFC could not be obtained in 4 patients Of the 20 patients in placebo arm, 4 did not receive the first bolus (drug or placebo) and 3 patients did not meet the inclusion criteria of TFG 0/1. cTFC could not be obtained in 3 patients'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 30days following PPCI', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 30days following primary percutaneous coronary intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 30days following primary percutaneous coronary intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)'}, {'type': 'SECONDARY', 'title': 'Safety Endpoint: Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'OG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 30days following primary percutaneous coronary intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 20 patients randomized to the placebo arm, 4 patients did not receive the first bolus (drug or placebo)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'FG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Did not receive first bolus.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study randomized 40 primary percutaneous coronary intervention (PPCI) patients from 6 hospitals in the United States. The patients were given either a volume matched bolus of intracoronary (IC) tenecteplase (TNK) (4 mg; n=20) or IC saline placebo (4 mg; n=16) before and following PPCI. 4 subjects were randomized but did not receive 1st bolus.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Treatment', 'description': 'Two (4mg) doses of tenecteplase'}, {'id': 'BG001', 'title': 'Placebo Control', 'description': 'Two (4mL) doses of sterile saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '55.4', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2008-01-07', 'resultsFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2008-01-17', 'lastUpdatePostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-06', 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Diameter Stenosis of the Culprit Lesion Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention', 'timeFrame': 'Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Decrease in Thrombus Grade in the Culprit Artery Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention', 'timeFrame': 'Following the First Bolus of Study Drug Prior to Primary Percutaneous Coronary Intervention'}, {'measure': 'Number of Patients With Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the Territory of the Culprit Artery Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'timeFrame': 'Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'description': 'Thrombolysis In Myocardial Infarction (TIMI) Myocardial Perfusion Grade (TMPG) of 2 or 3 in the territory of the culprit artery'}, {'measure': 'Measurements of Flow Velocity in the Culprit Artery in Terms of Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC)', 'timeFrame': 'Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'description': 'Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) in the culprit artery'}, {'measure': 'Number of Patients With Hyperemic Flow in the Culprit Artery. That is Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of Less Than 14', 'timeFrame': 'Following Primary Percutaneous Coronary Intervention Prior to Second Bolus of the Study Drug', 'description': 'Corrected Thrombolysis In Myocardial Infarction (TIMI) Frame Count (cTFC) of less than 14'}, {'measure': 'Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minor Bleeding', 'timeFrame': 'Through 30days following PPCI'}, {'measure': 'Safety Endpoint: Number of Patients Who Developed Thrombolysis In Myocardial Infarction (TIMI) Minimal Bleeding', 'timeFrame': 'Through 30days following primary percutaneous coronary intervention'}, {'measure': 'Safety Endpoint: Number of Patients Who Developed Cardiac Arrhythmias', 'timeFrame': 'Through 30days following primary percutaneous coronary intervention'}, {'measure': 'Safety Endpoint: Number of Deaths', 'timeFrame': 'Through 30days following primary percutaneous coronary intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ST-Elevation Myocardial Infarction', 'Acute Myocardial Infarction', 'No Reflow'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '31870492', 'type': 'DERIVED', 'citation': 'Gibson CM, Kumar V, Gopalakrishnan L, Singh P, Guo J, Kazziha S, Devireddy C, Pinto D, Marshall JJ, Stouffer GA, Mavromatis K, Grip L, Bainey KR; TIMI & PERFUSE Study Group. Feasibility and Safety of Low-Dose Intra-Coronary Tenecteplase During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (ICE T-TIMI 49). Am J Cardiol. 2020 Feb 15;125(4):485-490. doi: 10.1016/j.amjcard.2019.11.018. Epub 2019 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during balloon angioplasty for heart attacks.\n\nWe hypothesize that low-dose IC tenecteplase will enhance the breakdown of blood clots at the site of the culprit lesion leading to reduced damage to the heart muscle.', 'detailedDescription': 'The primary objective of this study is to gather preliminary data regarding the angiographic efficacy of the administration of low-dose adjunctive intracoronary (IC) tenecteplase during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). Efficacy will be assessed by measurements of both the angiographic characteristics of the culprit lesion as well as by measurements of epicardial flow and myocardial perfusion in the territory of the infarct-related artery. This study will also evaluate the safety of administering low-dose IC tenecteplase to subjects undergoing primary PCI for STEMI treated with standard therapy (aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors). Safety endpoints include the incidence of death, recurrent myocardial infarction (MI), abrupt vessel closure, subacute stent thrombosis, and TIMI major and minor bleeding events.\n\nPrompt reperfusion therapy with primary PCI in patients with STEMI improves clinical outcomes through salvage of myocardial tissue. The proposed pilot trial is a randomized, placebo-controlled trial to evaluate the effectiveness and safety of adjunctive low-dose IC tenecteplase in conjunction with standard medical therapy during primary PCI for STEMI. We hypothesized that low-dose IC tenecteplase will enhance fibrinolysis at the site of the culprit lesion leading to reduced microvascular dysfunction. As reduced dose tenecteplase will be injected directly into the coronary artery increasing local concentration of the drug with minor systemic effects, an improved safety profile is also expected from this mode of administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects (men or women) at least 18 years and less than 75 years of age and\n* Ischemic discomfort ≥20 minutes and ≤6 hours of duration and\n* ST elevation ≥1mm (≥0.1mV) in two contiguous limb leads OR ≥2mm (≥0.2mV) in two contiguous precordial leads and\n* Occluded infarct-related artery (TIMI Flow Grade 0 or 1) at the time of coronary angiography and\n* Planned primary PCI within 2 hours of hospital presentation and\n* Planned or concomitant use of aspirin, clopidogrel, unfractionated heparin, and Glycoprotein IIb/IIIa inhibition with intent to stent the infarct-related artery and\n* Informed consent able to be obtained\n\nExclusion Criteria:\n\nCLINICAL\n\n* Age ≥75 years\n* Maximal systolic blood pressure \\<80 mmHg AFTER initial fluid and/or pressor resuscitation.\n* Uncontrolled hypertension (SBP \\>180 OR DBP \\>110) at time of enrollment.\n* Cardiac arrest or arrhythmia requiring chest compressions or cardiopulmonary resuscitation.\n* Known pregnancy.\n\nBIOCHEMICAL\n\n* Known thrombocytopenia (platelet count \\<100,000)\n* Known severe renal insufficiency (creatinine \\>4.0 mg/dL).\n\nINCREASED BLEEDING RISK\n\n* Active internal bleeding\n* Recent (\\<3 months) gastrointestinal hemorrhage\n* Recent intracranial or intraspinal surgery, trauma, major surgery, or biopsy of a parenchymal organ (\\< 1 month)\n* Known coagulopathy, platelet disorder, or history of thrombocytopenia\n* Current warfarin therapy\n* Known neoplasm\n* Any known history of transient ischemic attack, cerebrovascular accident, or active intracranial pathology including arteriovenous malformation or aneurysm\n\nMEDICATIONS\n\n* Administration of a fibrinolytic agent within 72 hours\n* Known allergy or contraindication to fibrinolytics OR aspirin OR heparin OR clopidogrel\n\nANGIOGRAPHIC\n\n* Left Main Coronary artery culprit lesion\n* Ostial culprit lesion (ostium of LAD, LCX, or RCA).\n* Lesion in non-native coronary artery (e.g. saphenous vein graft, arterial conduit graft)\n* Subjects requiring urgent coronary artery bypass grafting'}, 'identificationModule': {'nctId': 'NCT00604695', 'acronym': 'ICE T-TIMI 49', 'briefTitle': 'A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Randomized Trial Evaluating Low-Dose IntraCoronary AdjunctivE Tenecteplase During Primary PCI for ST-Elevation Myocardial Infarction (ICE T)', 'orgStudyIdInfo': {'id': 'N3770S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Two (4mg) doses of tenecteplase', 'interventionNames': ['Drug: Tenecteplase']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Two (4mL) doses of sterile saline', 'interventionNames': ['Drug: Sterile Saline']}], 'interventions': [{'name': 'Tenecteplase', 'type': 'DRUG', 'description': 'Intracoronary injection of IV tenecteplase.', 'armGroupLabels': ['1']}, {'name': 'Sterile Saline', 'type': 'DRUG', 'description': 'Intracoronary injection of IV sterile saline', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30501', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Northeast Georgia Heart Center, PC', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical Center', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48307', 'city': 'Rochester', 'state': 'Michigan', 'country': 'United States', 'facility': 'Crittenton Hospital Medical Center', 'geoPoint': {'lat': 42.68059, 'lon': -83.13382}}, {'zip': '68025', 'city': 'Freemont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Heart Consultants, PC'}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'C. Michael Gibson, MS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C. Michael Gibson, MS, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor-Investigator', 'investigatorFullName': 'C. Michael Gibson, MS, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}