Polypill in Acute Coronary Syndrome

NCT05514938 | Completed Phase 2 FDA Drug

• 1 other identifier: STU2022-0604
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Acute coronary syndromes (ACS) represent a major contributor to mortality, morbidity, and healthcare costs. Effective therapies are widely available; however, adherence is low. This contributes to worse patient outcomes and increased risk of morbidity and mortality. The once-daily polypill leverages a population-based strategy that has previously demonstrated efficacy in improving adherence and access to therapy in low-resource settings, making it an innovative approach for improving post-ACS care. This study aims to investigate the utility of a polypill-based strategy for patients with ACS with drug eluting stent (DES) placement. The polypill will consist of a high-intensity statin (rosuvastatin 40 mg daily), aspirin 81 mg daily, and either clopidogrel 75 mg or prasugrel 10 mg daily.

Conditions

Acute Coronary Syndrome; Lipid Disorder; Coronary Artery Disease

Keywords

Acute coronary syndrome; Antiplatlet therapy; Statin; Lipids; Drug eluting stent

Outcome Measures

Primary Outcomes (2)

• Low Density Lipoprotein - Cholesterol

  Follow-up LDL-C at 30-days.

  1 month

• Platelet Reactivity

  Follow-up platelet reactivity at 30 days. Platelet reactivity was assessed using impedance aggregometry (Ohms, Ω, lower = better platelet inhibition)

  1 month

Secondary Outcomes (3)

• Adherence by self-report

  1 month

• Treatment Satisfaction

  1 month

• Quality of Life

  1 month

Study Arms (2)

Polypill

EXPERIMENTAL

Patients will be randomized to receiving a fixed-dose polypill in addition to other guideline-directed medical therapies prescribed by their physician. Polypill formulations will include rosuvastatin 40 mg, aspirin 81 mg, and prasugrel 10 mg daily or rosuvastatin 40 mg, aspirin 81 mg, and clopidogrel 75 mg.

Drug: Polypill

Usual Care (individual medications prescribed by primary cardiologist)

ACTIVE COMPARATOR

Patients will receive usual post-ACS care and medications prescribed by their provider. All of the individual components will be available at low- or no-cost to participants as individual pill formulations.

Drug: Usual Care (individual medications prescribed by primary cardiologist)

Interventions

Polypill DRUG

Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel or consisting of rosuvastatin, aspirin, and clopidogrel.

Polypill

Usual Care (individual medications prescribed by primary cardiologist) DRUG

Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel or clopidogrel.

Usual Care (individual medications prescribed by primary cardiologist)

Eligibility Criteria

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

You may qualify if:

• \. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.

You may not qualify if:

• Age \< 18
• Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
• Current need for inotropes or with cardiac index \< 2.2 L/min/m2
• 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 1-month study period
• Inability to provide written informed consent
• Pregnancy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (14)

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  PMID: 15007110 BACKGROUND

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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; Lipid Metabolism Disorders; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ambarish Pandey, MD, MSCS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

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: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 25, 2022
• Study Start: November 30, 2022
• Primary Completion: May 30, 2025
• Study Completion: June 5, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)