Single polypill combining aspirin, a P2Y12 inhibitor, and a statin after acute coronary syndrome
Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial
This trial tests whether giving adults who had an acute coronary syndrome a single combined pill with aspirin, a P2Y12 inhibitor, and a high-intensity statin helps them stick to their medicines and lowers complications after discharge.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07032389 on ClinicalTrials.gov |
What this trial studies
This pragmatic, randomized Phase 2 trial compares a polypill strategy to usual care in adults hospitalized with acute coronary syndrome who underwent percutaneous coronary intervention and are discharged on aspirin, a P2Y12 inhibitor (prasugrel or clopidogrel), and a high-intensity statin. Participants are randomized at hospital discharge and followed for about 12 months to measure feasibility, medication adherence, and clinical outcomes such as major adverse cardiac events. The intervention combines the three standard post-ACS drugs into a single pill to simplify regimens and potentially improve uptake. The trial is led by University of Texas Southwestern with NHLBI collaboration and enrolls at participating clinical sites.
Who should consider this trial
Good fit: Adults aged 18 or older who were hospitalized for an acute coronary syndrome, underwent PCI, and are discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin, who can provide informed consent, are ideal candidates.
Not a fit: Patients who need systemic anticoagulation, have contraindications or allergies to any polypill components, have a high bleeding risk or planned short-duration DAPT, are pregnant, or have life-limiting comorbidities are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the polypill could increase long-term medication adherence and reduce recurrent ischemic events after ACS by simplifying therapy.
How similar studies have performed: Previous polypill trials in cardiovascular prevention have improved adherence and risk-factor control, but combining antiplatelet therapy and a statin immediately after ACS is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Hospitalization for acute coronary syndrome with percutaneous coronary intervention * Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin Exclusion Criteria: * 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 12-month study period * Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \< 12 months * Inability to provide written informed consent * Pregnancy
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
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.