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Recruiting
NCT07032389
A Polypill for Acute Coronary Syndrome
Conditions: Acute Coronary Syndrome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 1000
Sponsor: University of Texas Southwestern Medical Center
Location: Baylor Scott and White Health System Dallas Texas
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 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
Source: ClinicalTrials.gov (NCT07032389). StuddyBuddy aggregates publicly available trial information.