Clinical trial NCT05175261: Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
Official title: Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: STEMI
NSTEMI
Lead sponsor: Prolocor, Inc
Sponsor class: INDUSTRY
First posted: 2022-01-03
Enrollment: 801
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ischemic
timeFrame: Study Duration (up to 3 years)
Secondary outcomes:
measure: Risk Score
timeFrame: Study Duration (up to 3 years)
measure: Bleeding
timeFrame: Study Duration (up to 3 years)
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: Prolocor, Inc
name: David J Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References: