Polypill for Coronary Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UT Southwestern Medical Center, Dallas, TX
Coronary Artery Disease+4 More
Polypill - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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 prasugrel 10 mg daily.

Eligible Conditions

  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • Lipoidosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 1 month

1 month
Number of participants who adhered to antiplatelet drug therapy
Number of participants who adhered to medication as assessed MMAS-8 questionnaire
Number of participants who adhered to medication as assessed by pill count
Number of participants who adhered to statin therapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Control
0%Cough
0%Cardiovascular event
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00603590) in the Control ARM group. Side effects include: Cough with 0%, Cardiovascular event with 0%.

Trial Design

2 Treatment Groups

Control
1 of 2
Polypill
1 of 2
Active Control
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Polypill · No Placebo Group · Phase 2

Polypill
Drug
Experimental Group · 1 Intervention: Polypill · Intervention Types: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Control treatment · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polypill
2011
Completed Phase 3
~2880

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Closest Location: UT Southwestern Medical Center · Dallas, TX
Photo of ut southwestern medical center 1Photo of ut southwestern medical center 2Photo of ut southwestern medical center 3
2001First Recorded Clinical Trial
2 TrialsResearching Coronary Artery Disease
321 CompletedClinical Trials

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
935 Previous Clinical Trials
594,380 Total Patients Enrolled
5 Trials studying Coronary Artery Disease
911 Patients Enrolled for Coronary Artery Disease
Ambarish Pandey, MD, MSCSPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References