Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes (MIRON-PLATELET)

March 7, 2026 updated by: Rohan Dharmakumar

Antiplatelets and Hemorrhagic MI

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

6180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Medical Imaging Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population consists of patients across multiple centers with available longitudinal follow-up data (up to 10 years), allowing for a comprehensive evaluation of clinical outcomes, mortality, major adverse cardiovascular events (MACE), and bleeding complications. Patients with a history of chronic antiplatelet or anticoagulation therapy before STEMI, known bleeding disorders, or incomplete medical records are excluded.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post-STEMI diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events (MACE)
Time Frame: 10 years
Composite of cardiovascular death, recurrent MI, stroke, and heart failure hospitalization.
10 years
Bleeding Complications
Time Frame: 10 years
Incidence of major and minor bleeding events as per the BARC (Bleeding Academic Research Consortium) criteria.
10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rohan Dharmakumar

Investigators

  • Study Director: Rohan Dharmakumar, PhD, Indiana University School of Medicine
  • Principal Investigator: Keyur P. Vora, MD MS FACC, Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

February 11, 2025

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19978g

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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