A Polypill for Acute Coronary Syndrome

NCT07032389 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU-2024-0861
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Coronary Syndrome; Polypill; Adherence

Outcome Measures

Primary Outcomes (1)

• Win ratio

  The win ratio will include all-cause death, in-stent thrombosis, ischemic events (MI, hospitalization for unstable angina, unplanned revascularization), and bleeding events (hospitalization or ED visit for bleeding, red blood cell transfusion, or a bleeding event that leads to cessation of DAPT)

  12-months

Secondary Outcomes (2)

• Medication adherence

  12-months

• Treatment satisfaction

  12-months

Study Arms (2)

Polypill

EXPERIMENTAL

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.

Combination Product: Polypill

Usual care

NO INTERVENTION

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

Interventions

Polypill COMBINATION_PRODUCT

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.

Polypill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Hospitalization for acute coronary syndrome with percutaneous coronary intervention
• Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75209, United States

RECRUITING

Related Publications (15)

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  PMID: 34431313 BACKGROUND

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• Rao S, Jamal Siddiqi T, Khan MS, Michos ED, Navar AM, Wang TJ, Greene SJ, Prabhakaran D, Khera A, Pandey A. Association of polypill therapy with cardiovascular outcomes, mortality, and adherence: A systematic review and meta-analysis of randomized controlled trials. Prog Cardiovasc Dis. 2022 Jul-Aug;73:48-55. doi: 10.1016/j.pcad.2022.01.005. Epub 2022 Feb 1.

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• Yusuf S, Joseph P, Dans A, Gao P, Teo K, Xavier D, Lopez-Jaramillo P, Yusoff K, Santoso A, Gamra H, Talukder S, Christou C, Girish P, Yeates K, Xavier F, Dagenais G, Rocha C, McCready T, Tyrwhitt J, Bosch J, Pais P; International Polycap Study 3 Investigators. Polypill with or without Aspirin in Persons without Cardiovascular Disease. N Engl J Med. 2021 Jan 21;384(3):216-228. doi: 10.1056/NEJMoa2028220. Epub 2020 Nov 13.

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• Roshandel G, Khoshnia M, Poustchi H, Hemming K, Kamangar F, Gharavi A, Ostovaneh MR, Nateghi A, Majed M, Navabakhsh B, Merat S, Pourshams A, Nalini M, Malekzadeh F, Sadeghi M, Mohammadifard N, Sarrafzadegan N, Naemi-Tabiei M, Fazel A, Brennan P, Etemadi A, Boffetta P, Thomas N, Marshall T, Cheng KK, Malekzadeh R. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet. 2019 Aug 24;394(10199):672-683. doi: 10.1016/S0140-6736(19)31791-X.

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MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The patient will be randomized into one of two groups: the polypill arm, receiving a 3-in-1 capsule containing dual antiplatelet therapy (DAPT) and a statin; or the usual care arm, receiving standard DAPT and statins as separate medications.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 24, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)