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Polypill in Acute Coronary Syndrome

NCT05514938 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-14

Study results available
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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.

Conditions

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.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Ambarish Pandey, MD, MSCS · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2025-05-30
Completion
2025-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514938 on ClinicalTrials.gov