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A Polypill for Acute Coronary Syndrome

RECRUITINGPhase 2Sponsored by University of Texas Southwestern Medical Center
Actively Recruiting
PhasePhase 2
SponsorUniversity of Texas Southwestern Medical Center
Started2025-12-05
Est. completion2029-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Acute Coronary SyndromeHeart Disease

Locations1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75209
Ambarish Pandey, MD214-645-9868ambarish.pandey@utsouthwestern.edu

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