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OpenTrials
Completed

NCT Number: NCT06851325

Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes

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.

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Imaging Research Institute

Indianapolis, Indiana, 46202, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Incidence of Hemorrhagic Myocardial Infarction (HMI) in STEMI Patients Receiving Different Antiplatelet Therapies

    Time frame: 30 days post-STEMI diagnosis

    Risk ratio assessment of the occurrence of hemorrhagic transformation in STEMI patients treated with different antiplatelet regimens.

Secondary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: 10 years

    Composite of cardiovascular death, recurrent MI, stroke, and heart failure hospitalization.

  2. Bleeding Complications

    Time frame: 10 years

    Incidence of major and minor bleeding events as per the BARC (Bleeding Academic Research Consortium) criteria.

  3. All cause mortality

    Time frame: 10 years

    Evaluation of all-cause mortality at 30 days, 1 year, 5 years, and 10 years across different antiplatelet therapy groups.

Sponsors and collaborators

Lead sponsor

Rohan Dharmakumar

Other

Registry information

Official study title

Antiplatelets and Hemorrhagic MI

Acronym: MIRON-PLATELET

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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