A Polypill for Acute Coronary Syndrome

NCT07032389 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2026-01-20

No results posted yet for this study

Summary

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

  • Acute Coronary Syndrome

Interventions

COMBINATION_PRODUCT

Polypill

The polypill is an inert capsule designed to combine multiple individual medications into a convenient, once-daily pill. In this case it will include DAPT and a statin.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2029-08-01
Completion
2029-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT07032389 on ClinicalTrials.gov