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NCT02545933 · ClinicalTrials.gov registry record · Phase 4
Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
NCT02545933: Completed Phase 4 study, sponsored by University of Florida.
NCT02545933 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 130 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02545933, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
Study Summary
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high, which may be in part due to the fact that other platelet signaling pathways, such as thrombin-induced platelet aggregation, continue to be activated. Vorapaxar is a protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation. It is approved for clinical use by the Food and Drug Administration for the reduction of thrombotic cardiovascular events in patients with a history of MI or with peripheral arterial disease. However, to date clinical trial experience with vorapaxar has been almost exclusively with the P2Y12 receptor inhibitor clopidogrel and the effects of vorapaxar in combination with antiplatelet therapy including prasugrel or ticagrelor, is largely unexplored. Further, the role of vorapaxar as part of a dual antithrombotic treatment regimen, in addition to a novel P2Y12 receptor inhibitor, with withdrawal of aspirin, represents another important area of clinical interest as it has the potential to maximize ischemic protection while reducing the risk of bleeding. The proposed prospective, randomized, parallel-design, open label, study conducted in a real world clinical setting of post-MI patients will aim to assess the pharmacodynamic effects of vorapaxar in addition to antiplatelet therapy with a novel P2Y12 receptor inhibitor (prasugrel or ticagrelor) with and without aspirin.
Primary Outcome
The primary end point of our study is the comparison of maximal platelet aggregation measured by light transmittance aggregometry using CAT (collagen-ADP-TRAP) between DAPT and DAPT plus vorapaxar after 30 days of treatment.
Interventions
- DRUG Aspirin
- DRUG Prasugrel
- DRUG Ticagrelor
- DRUG Vorapaxar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2016-02 |
| Est. Completion | 2020-01 |
| Phase | Phase 4 |
What the finished NCT02545933 record still lists
NCT02545933 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 4 interventions - of which Aspirin is the first listed.
NCT02545933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02545933 about?
NCT02545933 is a clinical study titled "Vorapaxar in Patients With Prior Myocardial Infarction Treated With Prasugrel and Ticagrelor". Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI). However, rates of ischemic recurrences remain high, which may be in part due to ...
What is the current status of trial NCT02545933?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2016-02. Estimated completion is 2020-01.
What interventions are being tested in trial NCT02545933?
The interventions under investigation include: Aspirin (DRUG), Prasugrel (DRUG), Ticagrelor (DRUG), Vorapaxar (DRUG).
Who is sponsoring clinical trial NCT02545933?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02545933's enrollment target sits among peer trials
130 622nd of 2000 higher than 1,370 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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