COMPLETED

Polypill in Acute Coronary Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-11-30
Study Completion:2025-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05514938

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.
  1. 1. Age \< 18
  2. 2. Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
  3. 3. Current need for inotropes or with cardiac index \< 2.2 L/min/m2
  4. 4. Current need for systemic anticoagulation
  5. 5. Contraindication to receive any components of the polypill
  6. 6. History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
  7. 7. Comorbidities that might be expected to limit lifespan within the 1-month study period
  8. 8. Inability to provide written informed consent
  9. 9. Pregnancy

Contacts and Locations

Principal Investigator

Ambarish Pandey, MD, MSCS
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-30
Study Completion Date2025-06-05

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2025-06-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Acute Coronary Syndrome
  • Lipid Disorder
  • Coronary Artery Disease