NCT05175261Completed
Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 764 (actual)
- First submitted
- 14 Dec 2021
- Start date
- Jan 2022
- Primary completion date
- Apr 2025
- Lead sponsor
- Prolocor, Inc
- Diseases
- Coronary artery disease
- NCT number
- NCT05175261
What you commit to
- Study type: Observational
- Participants enrolled: 764
- From Jan 2022 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation)
Other illness
- Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years
Other
- 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.
Who the study is looking for
- Type 1 Myocardial Infarction (STEMI and NSTEMI)
- Must have ≥ 2 of the following risk factors:
- Age ≥ 65
- Multi-vessel coronary artery disease (MVD) defined as ≥2 vessels or left main with a stenosis ≥50%
- Chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) ˂ 60 mL/min/1.73 m2
- Diabetes mellitus (DM)
- Prior MI
- Must agree to participate in the study, to comply with all study procedures and follow-up contact
- Signed the informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
Related publications
- Increased Platelet FcɣRIIa Identifies Patients at Greater Risk of Multiple Cardiovascular Events After Myocardial Infarction.JACC Adv · 2026 · PMID 42442169
- Platelet FcɣRIIa Expression Refines Clinical Risk Assessment After Myocardial Infarction.Catheter Cardiovasc Interv · 2026 · PMID 42304546
This page is information, not medical advice. Discuss any trial with your doctor.