Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07032389

Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes A Multicenter Randomized Controlled Trial

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

1000

Participants Needed

1

Research Sites

N/A

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

Researchers are evaluating whether combining standard medications prescribed after acute coronary syndrome (ACS) into a single polypill can improve outcomes following an ACS event. ACS includes conditions like heart attacks and unstable angina and leads to high rates of illness and death. Despite existing treatments, many patients stop taking their medications early, increasing their risk of further problems. This study is a pragmatic, multi-center, randomized trial aiming to test the feasibility and effectiveness of this polypill strategy after ACS. The study compares two groups: one receives a polypill containing aspirin 81 mg, rosuvastatin (40 or 10 mg), and either prasugrel 10 mg or clopidogrel 75 mg, combining dual antiplatelet therapy (DAPT) and a high-intensity statin into one pill taken once daily. The other group receives usual care with these medications prescribed as separate pills. This open-label trial focuses on the subacute period after percutaneous coronary intervention (PCI) in patients discharged on these therapies. Participants will be monitored for 12 months, with researchers assessing outcomes using a win ratio measure at 12 months. They will also track medication adherence and treatment satisfaction during this period. The study involves regular evaluations to observe the effects of the polypill strategy on medication use and cardiovascular events, aiming to address adherence challenges and improve post-ACS care over the course of the year.

CONDITIONS

Brief 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 12 months
  • 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Treatment

Duration - 12 months

Participants receive either the polypill combining aspirin, a statin, and a P2Y12 inhibitor, or usual care with individual pills, to manage their condition after acute coronary syndrome.

Multiple visits over 12 months

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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Published Research Related To This Trial

2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.

Ezra A Amsterdam, Nanette K Wenger, Ralph G Brindis...

https://pubmed.ncbi.nlm.nih.gov/25249585

2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery.

Glenn N Levine, Eric R Bates, John A Bittl...

https://pubmed.ncbi.nlm.nih.gov/27026020

Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins.

C Baigent, A Keech, P M Kearney...

https://pubmed.ncbi.nlm.nih.gov/16214597

Differences in incident and recurrent myocardial infarction among White and Black individuals aged 35 to 84: Findings from the ARIC community surveillance study.

Duygu Islek, Alvaro Alonso, Wayne Rosamond...

https://pubmed.ncbi.nlm.nih.gov/35660476

Racial and ethnic differences in time to acute reperfusion therapy for patients hospitalized with myocardial infarction.

Elizabeth H Bradley, Jeph Herrin, Yongfei Wang...

https://pubmed.ncbi.nlm.nih.gov/15467058

Racial Disparities in Adverse Cardiovascular Outcomes After a Myocardial Infarction in Young or Middle-Aged Patients.

Mariana Garcia, Zakaria Almuwaqqat, Kasra Moazzami...

https://pubmed.ncbi.nlm.nih.gov/34431313

Neighborhood Socioeconomic Disadvantage and Care After Myocardial Infarction in the National Cardiovascular Data Registry.

Jacob A Udell, Nihar R Desai, Shuang Li...

https://pubmed.ncbi.nlm.nih.gov/29848476