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RECRUITING Phase 2 ClinicalTrials.gov

A Polypill for Acute Coronary Syndrome

Sponsor: University of Texas Southwestern Medical Center • ClinicalTrials.gov ID: NCT07032389

Registry updated: 2026-09-23
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Description

The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.

Interventions

  • Polypill (Combination product)
    The polypill is an inert capsule designed to combine multiple individual medications into a convenient, once-daily pill. In this case it will include DAPT and a statin.

Eligibility criteria

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

Conditions

Acute Coronary Syndrome

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record