Polypill treatment for patients with acute coronary syndrome
Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population
This study is testing if a daily polypill that combines three heart medications can help people who have had a heart attack feel better and stay healthier compared to those taking separate medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05514938 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a once-daily polypill that combines a high-intensity statin, aspirin, and a P2Y12 inhibitor for patients who have experienced acute coronary syndrome and undergone percutaneous coronary intervention with drug-eluting stent placement. The polypill aims to improve medication adherence and access to therapy, which are critical for reducing morbidity and mortality associated with acute coronary syndromes. Participants will be compared to those receiving usual care with individual medications prescribed by their cardiologist. The study focuses on evaluating the utility of this innovative approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults admitted with acute coronary syndrome who are undergoing percutaneous coronary intervention with drug-eluting stent placement.
Not a fit: Patients under 18, those with severe renal impairment, or those with contraindications to any components of the polypill may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve medication adherence and health outcomes for patients recovering from acute coronary syndrome.
How similar studies have performed: Previous studies have shown that polypill strategies can improve adherence and health outcomes in various populations, suggesting potential success for this approach in acute coronary syndrome.
Eligibility criteria
Show full inclusion / exclusion 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, 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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ambarish Pandey, MD, MSCS — UT Southwestern Medical Center
- Study coordinator: Ambarish Pandey, MD, MSCS
- Email: ambarish.pandey@utsouthwestern.edu
- Phone: 214-645-9762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.