Recruiting
Phase 2

Polypill for ACS

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07032389

Conditions

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polypill

Study Details

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.

Conditions

Acute Coronary Syndrome

Study ID

NCT07032389

Start date

Dec 5, 2025

Status verified date

Sep, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Polypill

The polypill combines DAPT and a high intensity statin: (a) aspirin 81 mg, (b) rosuvastatin (40 or 10 mg) and (c) prasugrel 10 mg or clopidogrel 75 mg.

no intervention: Usual care

Participants in the usual care arm will be prescribed DAPT and statins as standard therapy in individual pills.

Interventions

Polypill

The polypill is an inert capsule designed to combine multiple individual medications into a convenient, once-daily pill. In this case it will include DAPT and a statin.

Primary outcome measure

  • Win ratio [ Time Frame: 6-months ]

Central Contacts and Locations

Locations

Baylor Scott & White, The Heart Hospital, Plano (THH, Plano)

Recruiting

Dallas, Texas, United States, 75093

Contacts

Javed Butler, MD

214-820-2687javed.butler@bswhealth.org

Neil Keshvani, MD

neil.keshvani@bswhealth.org

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75209

Contacts

Ambarish Pandey, MD

214-645-9868ambarish.pandey@utsouthwestern.edu

Parkland Health & Hospital System (PHHS)

Recruiting

Dallas, Texas, United States, 75235

Contacts

Ambarish Pandey, MD

617-869-8957Ambarish.Pandey@UTSouthwestern.edu

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Subhash Banerjee, MD

469-800-7400subhash.banerjee@bswhealth.org

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • Acute Coronary Syndrome
  • Polypill
  • Adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.