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NCT05514938 · ClinicalTrials.gov registry record · Phase 2
Polypill in Acute Coronary Syndrome
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT05514938: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT05514938 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05514938, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
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 either clopidogrel 75 mg or prasugrel 10 mg daily.
Primary Outcome
Within group change and between-group difference, polypill vs usual care. Represented as least squares means from linear regression models adjusting for baseline values, comparing polypill strategy versus usual care. The two relevant time points included baseline and 1 month laboratory values.
Interventions
- DRUG Polypill
- DRUG Usual Care (individual medications prescribed by primary cardiologist)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2025-06-05 |
| Phase | Phase 2 |
What the finished NCT05514938 record still lists
NCT05514938 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Polypill is the first listed.
NCT05514938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05514938 about?
NCT05514938 is a clinical study titled "Polypill in Acute Coronary Syndrome". 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...
What is the current status of trial NCT05514938?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2022-11-30. Estimated completion is 2025-06-05.
What interventions are being tested in trial NCT05514938?
The interventions under investigation include: Polypill (DRUG), Usual Care (individual medications prescribed by primary cardiologist) (DRUG).
Who is sponsoring clinical trial NCT05514938?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05514938's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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