Polypill in Acute Coronary Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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 prasugrel 10 mg daily.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center

Criteria

Inclusion Criteria:

1. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.

Exclusion Criteria:

1. Age < 18

2. Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified MDRD formula

3. Current need for inotropes or with cardiac index < 2.2 L/min/m2

4. History of coronary artery bypass graft surgery

5. Current need for systemic anticoagulation

6. Contraindication to receive any components of the polypill

7. History of allergic reaction or intolerance to aspirin, prasugrel, or rosuvastatin

8. Comorbidities that might be expected to limit lifespan within the 1-month study period

9. Inability to provide written informed consent

10. Pregnancy