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
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|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Lipid Disorder Coronary Artery Disease||Drug: Polypill Drug: Control treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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.
- 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.
- 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|
1. Patients admitted with acute coronary syndrome who undergo percutaneous coronary intervention with drug eluting stent placement.
- Age < 18
- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 as measured by the simplified MDRD formula
- Current need for inotropes or with cardiac index < 2.2 L/min/m2
- History of coronary artery bypass graft surgery
- Current need for systemic anticoagulation
- Contraindication to receive any components of the polypill
- History of allergic reaction or intolerance to aspirin, prasugrel, or rosuvastatin
- Comorbidities that might be expected to limit lifespan within the 1-month study period
- Inability to provide written informed consent
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
|Contact: Ambarish Pandey, MD, MSCSfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75235|
|Contact: Ambarish Pandey, MD 214-645-9762 email@example.com|
|Sub-Investigator: Neil Keshvani, MD|
|Principal Investigator:||Ambarish Pandey, MD, MSCS||UT Southwestern Medical Center|
|Responsible Party:||Ambarish Pandey, ASSISTANT PROFESSOR, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|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|
|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|
Acute coronary syndrome
Drug eluting stent
Coronary Artery Disease
Acute Coronary Syndrome
Lipid Metabolism Disorders
Arterial Occlusive Diseases