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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 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 130 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02545933
The ClinicalTrials.gov registry entry for NCT02545933 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Aspirin is the first listed.
NCT02545933 reports 0 study locations.
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.
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