Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes

Antiplatelets and Hemorrhagic MI

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06851325

Acronym

MIRON-PLATELET

Enrollment

6180

Registered

2025-02-28

Start date

2023-05-01

Completion date

2025-02-11

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, STEMI

Keywords

Hemorrhagic Myocardial Infarction, Antiplatelets, MACE

Brief summary

The MIRON-PLATELET study is a retrospective, observational multi-center analysis assessing the impact of different antiplatelet therapies on hemorrhagic myocardial infarction (HMI) incidence and outcomes in STEMI patients. Key endpoints include hemorrhagic transformation, MACE, bleeding complications, and 30-day mortality. Findings will offer insights into the safety and clinical implications of antiplatelet therapy in high-risk patients.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Inclusion criteria

1. Age ≥18-79 years at the time of STEMI diagnosis 2. Diagnosed with ST-segment elevation myocardial infarction (STEMI) based on standard clinical criteria 3. Received antiplatelet therapy as part of STEMI management 4. Underwent primary percutaneous coronary intervention (PCI) 5. Evidence of hemorrhagic MI confirmed by Cardiac Magnetic Resonance Imaging OR Post-PCI biomarker diagnostics 6. Availability of comprehensive medical records documenting STEMI presentation, treatment details, and clinical outcomes 7. Minimum of 30-day follow-up data, with extended follow-up available for up to 10 years

Exclusion criteria

1. Diagnosis of non-STEMI (NSTEMI), unstable angina, or other non-ischemic cardiomyopathies 2. History of prior hemorrhagic stroke or active intracranial bleeding before the index STEMI event 3. Known bleeding disorders (e.g., hemophilia, thrombocytopenia \<50,000/µL) 4. Use of chronic antiplatelet therapy (aspirin, clopidogrel, ticagrelor, prasugrel) before STEMI diagnosis 5. Use of long-term anticoagulation therapy (warfarin, DOACs such as apixaban, rivaroxaban, dabigatran) before STEMI diagnosis 6. Incomplete or missing medical records preventing outcome assessment 7. History of malignancy with life expectancy \<1 year at the time of STEMI diagnosis 8. Patients lost to follow-up before 30 days post-STEMI

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Hemorrhagic Myocardial Infarction (HMI) in STEMI Patients Receiving Different Antiplatelet Therapies	30 days post-STEMI diagnosis	Risk ratio assessment of the occurrence of hemorrhagic transformation in STEMI patients treated with different antiplatelet regimens.

Secondary

Measure	Time frame	Description
Major Adverse Cardiovascular Events (MACE)	10 years	Composite of cardiovascular death, recurrent MI, stroke, and heart failure hospitalization.
Bleeding Complications	10 years	Incidence of major and minor bleeding events as per the BARC (Bleeding Academic Research Consortium) criteria.
All cause mortality	10 years	Evaluation of all-cause mortality at 30 days, 1 year, 5 years, and 10 years across different antiplatelet therapy groups.

Countries

United States

Contacts

STUDY_DIRECTORRohan Dharmakumar, PhD

Indiana University School of Medicine

PRINCIPAL_INVESTIGATORKeyur P. Vora, MD MS FACC