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Completed

NCT Number: NCT05175261

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

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.

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Key information

Conditions

STEMI Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Requirement for treatment with full dose anticoagulant therapy (e.g., for atrial fibrillation)
  • 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.
  • Non-cardiovascular conditions that, in the judgment of the investigator, will limit survival to less than 2 years

Treatment and study plan

Prolocor pFCG test

Diagnostic Test

Perform pFCG test on patients admitted with myocardial infarction to assess prognosis

Primary outcomes

  1. Ischemic

    Time frame: Study Duration (up to 3 years)

    compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa

Secondary outcomes

  1. Risk Score

    Time frame: Study Duration (up to 3 years)

    • Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death

  2. Bleeding

    Time frame: Study Duration (up to 3 years)

    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

Sponsors and collaborators

Lead sponsor

Prolocor, Inc

Industry

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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