Phase 2
N=140
Polypill in Acute Coronary Syndrome
Acute Coronary Syndrome · Lipid Disorder · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT05514938 ↗Enrolled (actual)
140
Serious AEs
11.4%
Results posted
May 2026
Primary outcome: Primary: Low Density Lipoprotein - Cholesterol — -6.74; 0.53 mg/dL — p=0.27
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Polypill (Drug); Usual Care (individual medications prescribed by primary cardiologist) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Density Lipoprotein - Cholesterol |
-6.74; 0.53 | 0.27 |
| PRIMARY Platelet Reactivity |
0.55; 0.76 | 0.88 |
| SECONDARY Adherence by Self-report |
0.61; 0.21 | 0.47 |
| SECONDARY Treatment Satisfaction |
1.81; 0.65 | 0.82 |
| SECONDARY Quality of Life at 1 Month |
8.18; 5.08 | 0.59 |
Summary
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 with drug eluting stent (DES) placement. 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.
Eligibility Criteria
Inclusion Criteria
- Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.
Exclusion Criteria
- Age < 18
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Current need for inotropes or with cardiac index < 2.2 L/min/m2
- 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 that might be expected to limit lifespan within the 1-month study period
- Inability to provide written informed consent
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT05514938). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.