Trial Outcomes & Findings for Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa (NCT NCT05175261)

NCT ID: NCT05175261

Last Updated: 2025-09-09

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 764 participants
• Primary outcome timeframe: Study Duration (up to 3 years)
• Results posted on: 2025-09-09

Participant Flow

Participant milestones

Measure	Patients With Myocardial Infarction Adults (age\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.
Overall Study STARTED	764
Overall Study COMPLETED	757
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

Baseline characteristics by cohort

Measure	Patients With Myocardial Infarction n=764 Participants Adults (age\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	197 Participants n=5 Participants
Age, Categorical >=65 years	567 Participants n=5 Participants
Age, Continuous	69 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	245 Participants n=5 Participants
Sex: Female, Male Male	519 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	98 Participants n=5 Participants
Race (NIH/OMB) White	595 Participants n=5 Participants
Race (NIH/OMB) More than one race	50 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Patients With Myocardial Infarction n=567 Participants Adults (age\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.
Ischemic MI, stroke, and death	2.09 Hazard Ratio comparing high and low pFCG Interval 1.34 to 3.26
Ischemic MI and death	2.71 Hazard Ratio comparing high and low pFCG Interval 1.73 to 4.25
Ischemic MI	3.24 Hazard Ratio comparing high and low pFCG Interval 1.64 to 6.37
Ischemic death	2.57 Hazard Ratio comparing high and low pFCG Interval 1.5 to 4.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Patients With Myocardial Infarction n=764 Participants Adults (age\>18) were enrolled in this prospective observational non-interventional study after providing written informed consent. Patients were enrolled during hospitalization for type 1 MI (ST elevation or non-ST elevation). Most commonly, patients were enrolled shortly before discharge after therapeutic interventions were completed and clinical judgment was used to determine whether the MI was type 1. Inclusion criteria required that participants had at least 2 of the following: age ≥ 65, multi-vessel coronary artery disease, prior MI, chronic kidney disease (defined as glomerular filtration rate (GFR) ˂60 ml/min/1.73 m2), or diabetes mellitus. These criteria were used to target a higher risk patient group that would have an estimated risk of \~10% for the composite endpoint of MI, stroke, and death (15). This study focused on patients treated with antiplatelet therapy, however, a limited number (n = approximately 100) of patients treated with long term anticoagulants were permitted. Patients were excluded if they were enrolled in another trial in which the subject could receive anticoagulant or antiplatelet treatment as part of the trial intervention; and when non-cardiovascular conditions, in the judgment of the investigator, would limit survival to less than 2 years.

Bleeding

1.84 Hazard Ratio comparing high and low pFCG Interval 0.96 to 4.06

Adverse Events

Patients With Myocardial Infarction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 22 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David J Schneider, MD

Prolocor, Inc

Phone: 8023730071

Email: david.schneider@prolocor.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place