STEMIMIRON-PLATELETNCT06851325
Antiplatelets and Intramyocardial Hemorrhage in STEMI: Incidence and Outcomes
An observational study of STEMI and Acute Myocardial Infarction, run by Rohan Dharmakumar at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- STEMI, Acute Myocardial Infarction
- How many people
- 6,180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 11 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Imaging Research Institute
Indianapolis, Indiana, 46202
About this study
Official title: 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.
- Conditions
- STEMI, Acute Myocardial Infarction
- Keywords
- Hemorrhagic Myocardial Infarction, Antiplatelets, MACE
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-STEMI diagnosis
Secondary outcomes (3)
Major Adverse Cardiovascular Events (MACE)
Composite of cardiovascular death, recurrent MI, stroke, and heart failure hospitalization.
Measured: 10 years
Bleeding Complications
Incidence of major and minor bleeding events as per the BARC (Bleeding Academic Research Consortium) criteria.
Measured: 10 years
All cause mortality
Evaluation of all-cause mortality at 30 days, 1 year, 5 years, and 10 years across different antiplatelet therapy groups.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 May 2023
- Primary completion30 Jan 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohan Dharmakumar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rohan Dharmakumar, Indiana University
- Investigators
- Rohan Dharmakumar, PhD, Study director, Indiana UniversityKeyur P. Vora, MD MS FACC, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851325
- Sponsor's protocol ID
- 19978g
- Acronym
- MIRON-PLATELET
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39132339Vora 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.
PubMed 38613553
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelets and Hemorrhagic MI
- ClinicalTrials.gov ID
- NCT06851325
- Acronym / sponsor ID
- MIRON-PLATELET / 19978g
- Conditions
- STEMI, Acute Myocardial Infarction
- Keywords
- Hemorrhagic Myocardial Infarction, Antiplatelets, MACE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,180 participants (actual)
- Lead sponsor
- Rohan DharmakumarUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Major Adverse Cardiovascular Events (MACE)
Time frame: 10 years
Bleeding Complications
Time frame: 10 years
All cause mortality
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 39132339Vyas 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.
- Background: PubMed 38613553Vora 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohan Dharmakumar, PhD study director
Indiana University
Keyur P. Vora, MD MS FACC principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI and Acute Myocardial Infarction, run by Rohan Dharmakumar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Hemorrhagic Myocardial Infarction (HMI) in STEMI Patients Receiving Different Antiplatelet Therapies (time frame: 30 days post-STEMI diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06851325, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.