NCT05175261

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 764 (actual)
• Sponsor: Prolocor, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• STEMI
• NSTEMI

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Prolocor pFCG test	Perform pFCG test on patients admitted with myocardial infarction to assess prognosis

Timeline

• Start date: 2022-01-20
• Primary completion: 2025-04-18
• Completion: 2025-05-22
• First posted: 2022-01-03
• Last updated: 2025-09-09
• Results posted: 2025-09-09

Locations

1 site across 1 country: United States