NCT07032389RecruitingPhase 2
A Polypill for Acute Coronary Syndrome
Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 19 Jun 2025
- Start date
- 5 Dec 2025
- Primary completion date
- 1 Jun 2030
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT07032389
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 1000
- From 5 Dec 2025 to the primary completion date, 1 Jun 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
- Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \< 12 months
Other
- Current need for systemic anticoagulation
- Contraindication to receive any components of the polypill
- Comorbidities that might be expected to limit lifespan within the 12-month study period
- Inability to provide written informed consent
- Pregnancy
Who the study is looking for
- Age ≥ 18
- Hospitalization for acute coronary syndrome with percutaneous coronary intervention
- Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Baylor Scott & White, The Heart Hospital, Plano (THH, Plano) Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Parkland Health & Hospital System (PHHS) Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.