Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

September 6, 2025 updated by: Prolocor, Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

764

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  1. Type 1 Myocardial Infarction (STEMI and NSTEMI)

  2. Must have ≥ 2 of the following risk factors:

    1. Age ≥ 65
    2. Multi-vessel coronary artery disease (MVD) defined as ≥2 vessels or left main with a stenosis ≥50%
    3. Chronic kidney disease (CKD) defined as estimated glomerular filtration rate (GFR) ˂ 60 mL/min/1.73 m2
    4. Diabetes mellitus (DM)
    5. Prior MI
  3. Must agree to participate in the study, to comply with all study procedures and follow-up contact
  4. Signed the informed consent form

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Study Duration (up to 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Study Duration (up to 3 years)
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
Study Duration (up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prolocor, Inc

Investigators

  • Principal Investigator: David J Schneider, MD, Prolocor, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

April 18, 2025

Study Completion (Actual)

May 22, 2025

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (Actual)

January 3, 2022

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 6, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRL-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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