Polypill in Acute Coronary Syndrome

Description

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

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Study Overview

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Study Details

Study overview

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.

Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population

Polypill in Acute Coronary Syndrome

Condition
Acute Coronary Syndrome
Intervention / Treatment

-

Contacts and Locations

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.
  • 1. Age \< 18
  • 2. Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
  • 3. Current need for inotropes or with cardiac index \< 2.2 L/min/m2
  • 4. History of coronary artery bypass graft surgery
  • 5. Current need for systemic anticoagulation
  • 6. Contraindication to receive any components of the polypill
  • 7. History of allergic reaction or intolerance to aspirin, prasugrel or rosuvastatin, or rosuvastatin
  • 8. Comorbidities that might be expected to limit lifespan within the 1-month study period
  • 9. Inability to provide written informed consent
  • 10. Pregnancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Ambarish Pandey, MD, MSCS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2025-03-30