NCT07032389 A Polypill for Acute Coronary Syndrome
| NCT ID | NCT07032389 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2029-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,000 participants in total. It began in 2025-12-05 with a primary completion date of 2029-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07032389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07032389 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07032389 currently recruiting?
Yes, NCT07032389 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Texas Southwestern Medical Center to inquire about joining.
Where is the NCT07032389 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07032389 clinical trial?
NCT07032389 is sponsored by University of Texas Southwestern Medical Center. The trial plans to enroll 1,000 participants.