STEMINCT05175261
Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
An observational study of STEMI and NSTEMI, run by Prolocor, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Prolocor pFCG test
- How many people
- 764 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 22 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 9Show fewer
- Prior MI
- Must agree to participate in the study, to comply with all study procedures and follow-up contact
- Signed the informed consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Prolocor pFCG test
- Keywords
- biomarker, platelet, prognosis, cardiovascular
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolocor pFCG testDiagnostic test
Perform pFCG test on patients admitted with myocardial infarction to assess prognosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic
compare the hazard ratio for first occurrence of myocardial infarction (MI), stroke and death in patients with high vs low platelet FcGammaRIIa
Measured: Study Duration (up to 3 years)
Secondary outcomes (2)
Risk Score
- Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death
Measured: Study Duration (up to 3 years)
Bleeding
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
Measured: Study Duration (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start20 Jan 2022
- Primary completion18 Apr 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 764 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolocor, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David J Schneider, MD, Principal investigator, Prolocor, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175261
- Sponsor's protocol ID
- PRL-0001
- Status last verified
- Sep 2025
- First submitted
- 14 Dec 2021
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; Investigators. Predictive Value of Platelet FcgammaRIIa in Patients Treated With PCI Compared With Medical Therapy Alone After Myocardial Infarction. Circ Cardiovasc Interv. 2025 Apr;18(4):e014939. doi: 10.1161/CIRCINTERVENTIONS.124.014939. Epub 2025 Mar 26.
PubMed 40135363Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff A, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM. Platelet FcgammaRIIa as a Marker of Cardiovascular Risk After Myocardial Infarction. J Am Coll Cardiol. 2024 Oct 29;84(18):1721-1729. doi: 10.1016/j.jacc.2024.08.051.
PubMed 39443015Schneider DJ, Angiolillo DJ, Ibrahim H, Gurbel PA, Paul TK, Shapiro TA, McMahon SR, DiBattiste PM. Increased Platelet FcɣRIIa Identifies Patients at Greater Risk of Multiple Cardiovascular Events After Myocardial Infarction. JACC Adv. 2026 Jul 13;5(8):102981. doi: 10.1016/j.jacadv.2026.102981. Online ahead of print.
PubMed 42442169Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; behalf of the investigators. Platelet FcɣRIIa Expression Refines Clinical Risk Assessment After Myocardial Infarction. Catheter Cardiovasc Interv. 2026 Jun 16. doi: 10.1002/ccd.70691. Online ahead of print.
PubMed 42304546
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa
- ClinicalTrials.gov ID
- NCT05175261
- Acronym / sponsor ID
- PRL-0001
- Keywords
- biomarker, platelet, prognosis, cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 764 participants (actual)
- Lead sponsor
- Prolocor, IncIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Type 1 Myocardial Infarction (STEMI and NSTEMI)
- Must have ≥ 2 of the following risk factors:
- Must agree to participate in the study, to comply with all study procedures and follow-up contact
- Signed the informed consent form
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolocor pFCG testPerform pFCG test on patients admitted with myocardial infarction to assess prognosis | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Risk Score
Time frame: Study Duration (up to 3 years)
Bleeding
Time frame: Study Duration (up to 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40135363Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; Investigators. Predictive Value of Platelet FcgammaRIIa in Patients Treated With PCI Compared With Medical Therapy Alone After Myocardial Infarction. Circ Cardiovasc Interv. 2025 Apr;18(4):e014939. doi: 10.1161/CIRCINTERVENTIONS.124.014939. Epub 2025 Mar 26.
- Results publication: PubMed 39443015Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff A, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM. Platelet FcgammaRIIa as a Marker of Cardiovascular Risk After Myocardial Infarction. J Am Coll Cardiol. 2024 Oct 29;84(18):1721-1729. doi: 10.1016/j.jacc.2024.08.051.
- Derived from this study: PubMed 42442169Schneider DJ, Angiolillo DJ, Ibrahim H, Gurbel PA, Paul TK, Shapiro TA, McMahon SR, DiBattiste PM. Increased Platelet FcɣRIIa Identifies Patients at Greater Risk of Multiple Cardiovascular Events After Myocardial Infarction. JACC Adv. 2026 Jul 13;5(8):102981. doi: 10.1016/j.jacadv.2026.102981. Online ahead of print.
- Derived from this study: PubMed 42304546Schneider DJ, McMahon SR, Angiolillo DJ, Fanaroff AC, Ibrahim H, Hohl PK, Wanamaker BL, Effron MB, DiBattiste PM; behalf of the investigators. Platelet FcɣRIIa Expression Refines Clinical Risk Assessment After Myocardial Infarction. Catheter Cardiovasc Interv. 2026 Jun 16. doi: 10.1002/ccd.70691. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for STEMI
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J Schneider, MD principal investigator
Prolocor, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI and NSTEMI, run by Prolocor, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic (time frame: Study Duration (up to 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175261, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.