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Clinical Trial NCT07032389 (PolyACS) for Acute Coronary Syndrome is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Polypill for Acute Coronary Syndrome (PolyACS) Phase 2 1,000 Randomized Multi-Center

Recruiting
Clinical Trial NCT07032389 (PolyACS) is designed to study Treatment for Acute Coronary Syndrome. It is a Phase 2 interventional study that is recruiting, having started on 5 December 2025, with plans to enroll 1,000 participants. Led by University of Texas Southwestern Medical Center, it is expected to complete by 1 August 2029. The latest data from ClinicalTrials.gov was last updated on 20 January 2026.
Brief Summary
The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, mu...Show More
Detailed Description
Acute coronary syndrome (ACS) poses a major public health challenge in the United States. ACS, a constellation of acute cardiovascular conditions including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and unstable angina, is a major determinant of morbidity and mortality across the United States. An American will suffer from an ACS event every 40 seconds...Show More
Official Title

Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial

Conditions
Acute Coronary Syndrome
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • PolyACS
  • STU-2024-0861
NCT ID Number
NCT07032389
Start Date (Actual)
2025-12-05
Last Update Posted
2026-01-20
Completion Date (Estimated)
2029-08-01
Enrollment (Estimated)
1,000
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Acute Coronary Syndrome
Polypill
Adherence
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPolypill
The polypill combines DAPT and a high intensity statin: (a) aspirin 81 mg, (b) rosuvastatin (40 or 10 mg) and (c) prasugrel 10 mg or clopidogrel 75 mg.
Polypill
The polypill is an inert capsule designed to combine multiple individual medications into a convenient, once-daily pill. In this case it will include DAPT and a statin.
No InterventionUsual care
Participants in the usual care arm will be prescribed DAPT and statins as standard therapy in individual pills.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Win ratio
The win ratio will include all-cause death, in-stent thrombosis, ischemic events (MI, hospitalization for unstable angina, unplanned revascularization), and bleeding events (hospitalization or ED visit for bleeding, red blood cell transfusion, or a bleeding event that leads to cessation of DAPT)
12-months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Medication adherence
Medication adherence will be evaluated with the Morisky Medication Adherence Score (MMAS) and pill counts
12-months
Treatment satisfaction
Treatment satisfaction will be measured using the validated Treatment Satisfaction Questionnaire for Medication (TSQM)
12-months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Age ≥ 18
  • Hospitalization for acute coronary syndrome with percutaneous coronary intervention
  • Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin

  • Current need for systemic anticoagulation
  • Contraindication to receive any components of the polypill
  • History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
  • Comorbidities that might be expected to limit lifespan within the 12-month study period
  • Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for < 12 months
  • Inability to provide written informed consent
  • Pregnancy
University of Texas Southwestern Medical Center logoUniversity of Texas Southwestern Medical Center
National Heart, Lung, and Blood Institute (NHLBI) logoNational Heart, Lung, and Blood Institute (NHLBI)747 active studies to explore
Study Responsible Party
Ambarish Pandey, Principal Investigator, Associate Professor, University of Texas Southwestern Medical Center
No contact data.
1 Study Locations in 1 Countries

Texas

University of Texas Southwestern Medical Center, Dallas, Texas, 75209, United States
Ambarish Pandey, MD, Contact, 214-645-9868, [email protected]
Recruiting