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NCT02548650 · ClinicalTrials.gov registry record · Phase 4
Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT02548650 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 66 participants.
The verdict
NCT02548650, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor, more frequently clopidogrel, represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI) or peripheral arterial disease (PAD). However, rates of ischemic recurrences remain high. Vorapaxar is a protease-activated receptor (PAR)-1 inhibitor, which exerts potent inhibition of thrombin-mediated platelet aggregation. Patients with diabetes mellitus (DM) are known to be at increased risk of recurrent atherothrombotic events, which translates into worse outcomes, despite the use of standard of care therapy. This is in part due to the hyperreactive platelet phenotype, which characterizes DM patients, and to inadequate response to oral antiplatelet agents, including clopidogrel. Therefore, vorapaxar is an attractive treatment option for DM patients with a prior MI. The pharmacodynamic (PD) effects of vorapaxar in DM patients and how these may differentiate from non-DM patients has not been explored. Further, the role of vorapaxar as part of a dual antithrombotic treatment regimen combined with clopidogrel (and stopping aspirin) represents another important area of clinical interest. The proposed prospective, parallel-design study conducted in patients post-MI or with PAD with and without DM will aim the assess the pharmacodynamic effects of vorapaxar in addition to standard DAPT with aspirin and clopidogrel as well as in combination with clopidogrel only following aspirin withdrawal.
Interventions
- DRUG Aspirin
- DRUG Clopidogrel
- DRUG Vorapaxar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2016-03-25 |
| Est. Completion | 2019-02-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02548650
The ClinicalTrials.gov registry entry for NCT02548650 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 66 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 3 interventions - of which Aspirin is the first listed.
NCT02548650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02548650 about?
NCT02548650 is a clinical study titled "Vorapaxar as an Add-On Antiplatelet Therapy in Patients With and Without Diabetes Mellitus". Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor, more frequently clopidogrel, represents the standard of care for the long-term secondary prevention of atherothrombotic events in patients with myocardial infarction (MI) or peripheral arterial disease (PAD). However, rate...
What is the current status of trial NCT02548650?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2016-03-25. Estimated completion is 2019-02-14.
What interventions are being tested in trial NCT02548650?
The interventions under investigation include: Aspirin (DRUG), Clopidogrel (DRUG), Vorapaxar (DRUG).
Who is sponsoring clinical trial NCT02548650?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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