Polypill for Coronary Artery Disease
Phase-Based Progress Estimates
Effectiveness
Safety
UT Southwestern Medical Center, Dallas, TX
Coronary Artery Disease+4 More
Polypill - DrugEligibility
18+
All Sexes
What conditions do you have?
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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
Other trials for Coronary Artery Disease
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
This is further along than 68% of similar trials
Other trials for Coronary Artery Disease
Side Effects for
Control
0%Cough
0%Cardiovascular event
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: DrugControl
Drug
ActiveComparator Group · 1 Intervention: Control treatment · Intervention Types: DrugTreatment
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
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 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
- Amsterdam, Ezra A., Nanette K. Wenger, Ralph G. Brindis, Donald E. Casey Jr., Theodore G. Ganiats, David R. Holmes Jr., Allan S. Jaffe, et al.. 2014. “2014 AHA/ACC Guideline for the Management of Patients with Non–st-elevation Acute Coronary Syndromes”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2014.09.017.
- Levine, Glenn N., Eric R. Bates, John A. Bittl, Ralph G. Brindis, Stephan D. Fihn, Lee A. Fleisher, Christopher B. Granger, et al.. 2016. “2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease: A Report of the American College of Cardiology/american Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of St-elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients with Non–st-elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0000000000000404.
- Bhatt, Deepak L., and Eric J. Topol. 2003. “Scientific and Therapeutic Advances in Antiplatelet Therapy”. Nature Reviews Drug Discovery. Springer Science and Business Media LLC. doi:10.1038/nrd985.
- “Efficacy and Safety of Cholesterol-lowering Treatment: Prospective Meta-analysis of Data from 90 056 Participants in 14 Randomised Trials of Statins”. 2005. “Efficacy and Safety of Cholesterol-lowering Treatment: Prospective Meta-analysis of Data from 90 056 Participants in 14 Randomised Trials of Statins”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(05)67394-1.
- Cannon, Christopher P., Eugene Braunwald, Carolyn H. McCabe, Daniel J. Rader, Jean L. Rouleau, Rene Belder, Steven V. Joyal, Karen A. Hill, Marc A. Pfeffer, and Allan M. Skene. 2004. “Intensive Versus Moderate Lipid Lowering with Statins After Acute Coronary Syndromes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa040583.
- Ho, P. Michael. 2008. “Incidence of Death and Acute Myocardial Infarction Associated with Stopping Clopidogrel After Acute Coronary Syndrome”. Jama. American Medical Association (AMA). doi:10.1001/jama.299.5.532.
- Spertus, John A., Richard Kettelkamp, Clifton Vance, Carole Decker, Philip G. Jones, John S. Rumsfeld, John C. Messenger, et al.. 2006. “Prevalence, Predictors, and Outcomes of Premature Discontinuation of Thienopyridine Therapy After Drug-eluting Stent Placement”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.106.618066.
- Iakovou, Ioannis. 2005. “Incidence, Predictors, and Outcome of Thrombosis After Successful Implantation of Drug-eluting Stents”. Jama. American Medical Association (AMA). doi:10.1001/jama.293.17.2126.
- Lemstra, Mark, and David Blackburn. 2012. “Nonadherence to Statin Therapy: Discontinuation After a Single Fill”. Canadian Journal of Cardiology. Elsevier BV. doi:10.1016/j.cjca.2012.03.018.
- Roshandel, Gholamreza, Masoud Khoshnia, Hossein Poustchi, Karla Hemming, Farin Kamangar, Abdolsamad Gharavi, Mohammad Reza Ostovaneh, et al.. 2019. “Effectiveness of Polypill for Primary and Secondary Prevention of Cardiovascular Diseases (polyiran): A Pragmatic, Cluster-randomised Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(19)31791-x.
- Muñoz, Daniel, Prince Uzoije, Cassandra Reynolds, Roslynn Miller, David Walkley, Susan Pappalardo, Phyllis Tousey, et al.. 2019. “Polypill for Cardiovascular Disease Prevention in an Underserved Population”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1815359.
- “Effects of a Polypill (polycap) on Risk Factors in Middle-aged Individuals Without Cardiovascular Disease (TIPS): A Phase II, Double-blind, Randomised Trial”. 2009. “Effects of a Polypill (polycap) on Risk Factors in Middle-aged Individuals Without Cardiovascular Disease (TIPS): A Phase II, Double-blind, Randomised Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(09)60611-5.
- Thom, Simon. 2013. “Effects of a Fixed-dose Combination Strategy on Adherence and Risk Factors in Patients with or at High Risk of CVD”. Jama. American Medical Association (AMA). doi:10.1001/jama.2013.277064.
- Yusuf, Salim, Jackie Bosch, Gilles Dagenais, Jun Zhu, Denis Xavier, Lisheng Liu, Prem Pais, et al.. 2016. “Cholesterol Lowering in Intermediate-risk Persons Without Cardiovascular Disease”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1600176.
- Ambarish Pandey 2022. "Polypill in Acute Coronary Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05514938.
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