CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 140 enrolled
Drug / intervention
Polypill +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05514938
NCT05514938Phase 2Completed

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

University of Texas Southwestern Medical Center·interventional·Posted Aug 25, 2022·Updated May 14, 2026

In Brief

A Phase 2 clinical trial evaluating Polypill and Usual Care (individual medications prescribed by primary cardiologist) for Acute Coronary Syndrome and 2 related conditions. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedAug 25, 2022
Enrollment StartNov 30, 2022
Primary CompletionMay 30, 2025
Study CompletionJun 5, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 3.9 years ago

Interventions

Polypilldrug

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

Usual Care (individual medications prescribed by primary cardiologist)drug

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