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COMPLETED
NCT05514938
PHASE2

Polypill in Acute Coronary Syndrome

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

Acute coronary syndromes (ACS) represent a major contributor to mortality, morbidity, and healthcare costs. Effective therapies are widely available; however, adherence is low. This contributes to worse patient outcomes and increased risk of morbidity and mortality. The once-daily polypill leverages a population-based strategy that has previously demonstrated efficacy in improving adherence and access to therapy in low-resource settings, making it an innovative approach for improving post-ACS care. This study aims to investigate the utility of a polypill-based strategy for patients with ACS with drug eluting stent (DES) placement. The polypill will consist of a high-intensity statin (rosuvastatin 40 mg daily), aspirin 81 mg daily, and either clopidogrel 75 mg or prasugrel 10 mg daily.

Official title: Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2022-11-30

Completion Date

2025-06-05

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

Polypill

Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.

DRUG

Usual Care (individual medications prescribed by primary cardiologist)

Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States