Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

STEMI Clinical Trial

Official title:

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05175261
• Other study ID #: PRL-0001
• Status: Active, not recruiting
• Start date: January 20, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Prolocor, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 801
• Est. completion date: June 30, 2025
• Est. primary completion date: March 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NSTEMI
• STEMI

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Prolocor, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic	determine whether platelet expression of Fc?RIIa is associated with risk of myocardial infarction (MI), stroke and death.	Study Duration (up to 3 years)
Secondary	Risk Score	• Develop a score that combines clinical characteristics plus platelet expression of Fc?RIIa to determine the risk of MI, stroke, and death	Study Duration (up to 3 years)
Secondary	Bleeding	• Determine whether platelet expression of Fc?RIIa is associated with risk of major bleeding	Study Duration (up to 3 years)