Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes

NCT06851325 | Completed

• 1 other identifier: 19978g
• Study Type: observational
• Target: 6,180
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction; STEMI

Keywords

Hemorrhagic Myocardial Infarction; Antiplatelets; MACE

Outcome Measures

Primary Outcomes (1)

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

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

  30 days post-STEMI diagnosis

Secondary Outcomes (3)

• Major Adverse Cardiovascular Events (MACE)

  10 years

• Bleeding Complications

  10 years

• All cause mortality

  10 years

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rohan Dharmakumar: lead

Study Sites (1)

Medical Imaging Research Institute

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Vyas R, Changal KH, Bhuta S, Pasadyn V, Katterle K, Niedoba MJ, Vora K, Dharmakumar R, Gupta R. Impact of Intramyocardial Hemorrhage on Clinical Outcomes in ST-Elevation Myocardial Infarction: A Systematic Review and Meta-analysis. J Soc Cardiovasc Angiogr Interv. 2022 Aug 26;1(6):100444. doi: 10.1016/j.jscai.2022.100444. eCollection 2022 Nov-Dec.

  PMID: 39132339 BACKGROUND

• Vora KP, Kumar A, Krishnam MS, Prato FS, Raman SV, Dharmakumar R. Microvascular Obstruction and Intramyocardial Hemorrhage in Reperfused Myocardial Infarctions: Pathophysiology and Clinical Insights From Imaging. JACC Cardiovasc Imaging. 2024 Jul;17(7):795-810. doi: 10.1016/j.jcmg.2024.02.003. Epub 2024 Apr 10.

  PMID: 38613553 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Rohan Dharmakumar, PhD

  Indiana University School of Medicine

  STUDY DIRECTOR

• Keyur P. Vora, MD MS FACC

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: May 1, 2023
• Primary Completion: January 30, 2025
• Study Completion: February 11, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)