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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: Completed Phase 4 study, sponsored by University of Florida.
NCT02548650 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in diabetic patients
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 |
What the finished NCT02548650 record still lists
NCT02548650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.
NCT02548650 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02548650's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 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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