Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07032389

A Polypill for Acute Coronary Syndrome

Led by University of Texas Southwestern Medical Center · Updated on 2026-01-20

1000

Participants Needed

1

Research Sites

190 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Polypill for Acute Coronary Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hospitalized for acute coronary syndrome with percutaneous coronary intervention
  • Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin
Not Eligible

You will not qualify if you...

  • 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 expected to limit lifespan within the 12-month study period
  • Increased risk of bleeding or planned urgent surgery requiring DAPT for less than 12 months
  • Inability to provide written informed consent
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75209

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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