Single polypill combining aspirin, a P2Y12 inhibitor, and a statin after acute coronary syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, randomized Phase 2 trial compares a polypill strategy to usual care in adults hospitalized with acute coronary syndrome who underwent percutaneous coronary intervention and are discharged on aspirin, a P2Y12 inhibitor (prasugrel or clopidogrel), and a high-intensity statin. Participants are randomized at hospital discharge and followed for about 12 months to measure feasibility, medication adherence, and clinical outcomes such as major adverse cardiac events. The intervention combines the three standard post-ACS drugs into a single pill to simplify regimens and potentially improve uptake. The trial is led by University of Texas Southwestern with NHLBI collaboration and enrolls at participating clinical sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18
* Hospitalization for acute coronary syndrome with percutaneous coronary intervention
* Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin

Exclusion Criteria:

* Current need for systemic anticoagulation
* Contraindication to receive any components of the polypill
* History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
* Comorbidities that might be expected to limit lifespan within the 12-month study period
* Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \< 12 months
* Inability to provide written informed consent
* Pregnancy

Where it's running

• Baylor Scott & White, The Heart Hospital, Plano (THH, Plano)
  Dallas, Texas, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Parkland Health & Hospital System (PHHS)
  Dallas, Texas, United States Recruiting
• Baylor University Medical Center
  Dallas, Texas, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.