Clinical trial NCT06851325: Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes
Official title: Antiplatelets and Hemorrhagic MI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Acute Myocardial Infarction
Keywords: Hemorrhagic Myocardial Infarction
Antiplatelets
MACE
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 6180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Hemorrhagic Myocardial Infarction (HMI) in STEMI Patients Receiving Different Antiplatelet Therapies
timeFrame: 30 days post-STEMI diagnosis
Secondary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 10 years
measure: Bleeding Complications
timeFrame: 10 years
measure: All cause mortality
timeFrame: 10 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Krannert Cardiovascular Research Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rohan Dharmakumar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Keyur P. Vora, MD FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.