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A Polypill for Acute Coronary Syndrome

Study acronym: PolyACS
StatusRecruiting
PhasePhase 2
Started2025-12-05
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Aug 1, 2029 → Jun 1, 2030
See other at-risk trials from University of Texas Southwestern Medical Center

Amendment history

2026-07-08
Study Status, Outcome Measures, Contacts/Locations v5
Primary completion pushed: 2029-08-01 → 2030-06-01
Completion pushed: 2029-08-01 → 2030-07-31
Study sites1→2
Secondary endpointsdetails revised at 2 of 2 entries
2026-01-16
Study Status, Study Design v4
PhasePhase 3→Phase 2
2025-12-10
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-12-01→confirmed 2025-12-05
Study sitesdetails revised at 1 of 1 site
2025-10-17
Study Status, Oversight v2
Start date2025-10-01→2025-12-01
2025-08-18
Study Status, Sponsor/Collaborators v1
Start date2025-08-01→2025-10-01
Collaborators1 entry, revised
National InstitutesHeart, ofLung, Healthand Blood Institute (NIHNHLBI)
2025-06-19
Original filing
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.
Trial Details
NCT Number NCT07032389
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Acute Coronary Syndrome
Enrollment 1,000 participants
Start Date 2025-12-05
Primary Completion 2030-06-01 (estimated)
Study Completion 2030-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-23