NCT05514938CompletedPhase 2
Polypill in Acute Coronary Syndrome
Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
Acute coronary syndromes (ACS) represent a major contributor to mortality, morbidity, and healthcare costs. Effective therapies are widely available; however, adherence is low. This contributes to worse patient outcomes and increased risk of morbidity and mortality. The once-daily polypill leverages a population-based strategy that has previously demonstrated efficacy in improving adherence and access to therapy in low-resource settings, making it an innovative approach for improving post-ACS care. This study aims to investigate the utility of a polypill-based strategy for patients with ACS or high-risk PCI. The polypill will consist of a high-intensity statin (rosuvastatin 40 mg daily), aspirin 81 mg daily, and either clopidogrel 75 mg or prasugrel 10 mg daily.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 30 Nov 2022
- Primary completion date
- 30 May 2025
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05514938
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 140
- From 30 Nov 2022 to the primary completion date, 30 May 2025
- 2 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
- Current need for inotropes or with cardiac index \< 2.2 L/min/m2
- History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
Age
- Age \< 18
Other
- Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Current need for systemic anticoagulation
- Contraindication to receive any components of the polypill
- Comorbidities that might be expected to limit lifespan within the 1-month study period
- Inability to provide written informed consent
- Pregnancy
Who the study is looking for
- 1\. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Parkland Health & Hospital System (PHHS) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.