Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-29 @ 3:37 AM
Study NCT ID:
NCT05175261
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2021-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D000072658', 'term': 'Non-ST Elevated 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.schneider@prolocor.com', 'phone': '8023730071', 'title': 'David J Schneider, MD', 'organization': 'Prolocor, Inc'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected through study completion, an average of 21 months', 'description': 'Myocardial infarction, stroke, bleeding, and death were study endpoints and so were not considered adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With Myocardial Infarction', 'description': 'Adults (age\\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \\~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.', 'otherNumAtRisk': 764, 'deathsNumAtRisk': 764, 'otherNumAffected': 0, 'seriousNumAtRisk': 764, 'deathsNumAffected': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ischemic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '567', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Myocardial Infarction', 'description': 'Adults (age\\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \\~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.'}], 'classes': [{'title': 'MI, stroke, and death', 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '1.34', 'upperLimit': '3.26'}]}]}, {'title': 'MI and death', 'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '1.73', 'upperLimit': '4.25'}]}]}, {'title': 'MI', 'categories': [{'measurements': [{'value': '3.24', 'groupId': 'OG000', 'lowerLimit': '1.64', 'upperLimit': '6.37'}]}]}, {'title': 'death', 'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study Duration (up to 3 years)', 'description': 'compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa', 'unitOfMeasure': 'Hazard Ratio comparing high and low pFCG', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk Score', 'timeFrame': 'Study Duration (up to 3 years)', 'description': '• Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Myocardial Infarction', 'description': 'Adults (age\\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \\~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.84', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '4.06'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study Duration (up to 3 years)', 'description': 'compare the hazard ratio for first occurrence of bleeding (bleeding academic research consortium 2, 3, and 5) in patients with high vs low platelet FcGammaRIIa', 'unitOfMeasure': 'Hazard Ratio comparing high and low pFCG', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Myocardial Infarction', 'description': 'Adults (age\\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \\~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '764'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '757'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '764', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Myocardial Infarction', 'description': 'Adults (age\\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \\~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '197', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '567', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '245', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '519', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '98', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '595', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-21', 'size': 828770, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-24T10:15', 'hasProtocol': True}, {'date': '2023-07-24', 'size': 412151, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-24T10:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 764}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-06', 'studyFirstSubmitDate': '2021-12-14', 'resultsFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-06', 'studyFirstPostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ischemic', 'timeFrame': 'Study Duration (up to 3 years)', 'description': 'compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa'}], 'secondaryOutcomes': [{'measure': 'Risk Score', 'timeFrame': 'Study Duration (up to 3 years)', 'description': '• Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death'}, {'measure': 'Bleeding', 'timeFrame': 'Study Duration (up to 3 years)', 'description': 'compare the hazard ratio for first occurrence of bleeding (bleeding academic research consortium 2, 3, and 5) in patients with high vs low platelet FcGammaRIIa'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['biomarker', 'platelet', 'prognosis', 'cardiovascular'], 'conditions': ['STEMI', 'NSTEMI']}, 'referencesModule': {'references': [{'pmid': '40135363', 'type': 'RESULT', 'citation': 'Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; Investigators. Predictive Value of Platelet FcgammaRIIa in Patients Treated With PCI Compared With Medical Therapy Alone After Myocardial Infarction. Circ Cardiovasc Interv. 2025 Apr;18(4):e014939. doi: 10.1161/CIRCINTERVENTIONS.124.014939. Epub 2025 Mar 26.'}, {'pmid': '39443015', 'type': 'RESULT', 'citation': 'Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff A, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM. Platelet FcgammaRIIa as a Marker of Cardiovascular Risk After Myocardial Infarction. J Am Coll Cardiol. 2024 Oct 29;84(18):1721-1729. doi: 10.1016/j.jacc.2024.08.051.'}]}, 'descriptionModule': {'briefSummary': 'This is a Prospective, Observational Multicenter Non-Interventional Cohort Study. The primary objective is to determine whether platelet expression of FcγRIIa is associated with risk of myocardial infarction (MI), stroke and death. Secondary objectives include: 1) Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death; and 2) Determine whether platelet expression of FcγRIIa is associated with risk of major bleeding. The primary endpoint is the composite of death, MI and stroke. A secondary endpoint is the incidence of clinically significant bleeding according to the Bleeding Academic Research Consortium (BARC) scale type 2-5. Approximately 800 male and female subjects with confirmed MI \\[ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)\\] will be enrolled before hospital discharge for the index event. Approximately 10 sites in the United States will participate in this study. It is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. The study and subject follow-up will continue until 1) at least 80 ischemic events (MI, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 800 male and female subjects with confirmed MI \\[ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)\\] will be enrolled before hospital discharge for the index event.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Type 1 Myocardial Infarction (STEMI and NSTEMI)\n2. Must have ≥ 2 of the following risk factors:\n\n 1. Age ≥ 65\n 2. Multi-vessel coronary artery disease (MVD) defined as ≥2 vessels or left main with a stenosis ≥50%\n 3. Chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) ˂ 60 mL/min/1.73 m2\n 4. Diabetes mellitus (DM)\n 5. Prior MI\n3. Must agree to participate in the study, to comply with all study procedures and follow-up contact\n4. Signed the informed consent form\n\nExclusion Criteria:\n\n1. Requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation)\n2. Participation in another trial in which the subject is known to receive or could receive anticoagulant or antiplatelet treatment as part of the trial intervention.\n3. Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years'}, 'identificationModule': {'nctId': 'NCT05175261', 'briefTitle': 'Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prolocor, Inc'}, 'officialTitle': 'Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa', 'orgStudyIdInfo': {'id': 'PRL-0001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prolocor pFCG test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Perform pFCG test on patients admitted with myocardial infarction to assess prognosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'David J Schneider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prolocor, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prolocor, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}