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Heart attack drug safety under scrutiny: new study examines bleeding risks

NCT ID NCT06851325

Knowledge-focused Sponsor: Rohan Dharmakumar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at over 6,000 heart attack patients to see how different antiplatelet medications affect the risk of bleeding inside the heart. Researchers compared outcomes like heart-related events, bleeding complications, and death within 30 days. The goal is to help doctors choose safer treatments for high-risk patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose safer antiplatelet treatments for heart attack patients, reducing the risk of bleeding complications.
What could go wrong
This is an observational study, not a clinical trial testing a new drug. It cannot prove cause and effect, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

6,180 people

The number who actually took part.

Started

May 2023

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 79 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute myocardial infarction myocardial infarction ST-elevation myocardial infarction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myocardial infarction STEMI

Contacts and locations

Locations

  • Medical Imaging Research Institute

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.