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Polypill in Acute Coronary Syndrome (POLY-ACS)

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ClinicalTrials.gov Identifier: NCT05514938
Recruitment Status : Recruiting
First Posted : August 25, 2022
Last Update Posted : December 20, 2022
Information provided by (Responsible Party):
Ambarish Pandey, University of Texas Southwestern Medical Center

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 prasugrel 10 mg daily.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Lipid Disorder Coronary Artery Disease Drug: Polypill Drug: Control treatment Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Polypill Strategy for Evidence-Based Management of Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention in an Underserved Patient Population
Actual Study Start Date : November 30, 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Polypill
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.
Drug: Polypill
Polypill formulation consisting of rosuvastatin, aspirin, and prasugrel.

Active Comparator: Control
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: Control treatment
Typical prescriptions for post-acute coronary syndrome care including statin, aspirin, and prasugrel.

Primary Outcome Measures :
  1. Number of participants who adhered to antiplatelet drug therapy [ Time Frame: 1 month ]
    The number of participants who adhered to antiplatelet drug therapy is assessed by platelet function aggregometry testing.

  2. Number of participants who adhered to statin therapy [ Time Frame: 1 month ]
    The number of participants who adhered to statin therapy is assessed by LDL-C (low density lipoprotein-cholesterol ) levels via lab draw.

Secondary Outcome Measures :
  1. Number of participants who adhered to medication as assessed by pill count [ Time Frame: 1 month ]
    The number of participants who adhered to medication is assessed by pill count done for each of the participants.

  2. Number of participants who adhered to medication as assessed MMAS-8 questionnaire [ Time Frame: 1 month ]
    The number of participants who adhered to medication will be assessed by Morisky Medication Adherence (MMAS-8) questionnaire which is a validated assessment tool used to measure non-adherence. Possible scores range from 0 to 8, with higher scores indicating higher adherence.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  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
  8. Comorbidities that might be expected to limit lifespan within the 1-month study period
  9. Inability to provide written informed consent
  10. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05514938

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Contact: Ambarish Pandey, MD, MSCS 214-645-9762 ambarish.pandey@utsouthwestern.edu

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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Ambarish Pandey, MD    214-645-9762    ambarish.pandey@utsouthwestern.edu   
Sub-Investigator: Neil Keshvani, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Ambarish Pandey, MD, MSCS UT Southwestern Medical Center
Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 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. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available. Erratum In: Circulation. 2016 Sep 6;134(10):e192-4.

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Responsible Party: Ambarish Pandey, ASSISTANT PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05514938    
Other Study ID Numbers: STU2022-0604
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ambarish Pandey, University of Texas Southwestern Medical Center:
Acute coronary syndrome
Antiplatlet therapy
Drug eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Acute Coronary Syndrome
Lipid Metabolism Disorders
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Metabolic Diseases