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NCT03718429 · ClinicalTrials.gov registry record · Phase 4
Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 86
- Enrollment target
NCT03718429: Completed Phase 4 study, sponsored by University of Florida.
NCT03718429 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 86 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03718429, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 86 participants
- Enrollment target
Study Summary
Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. To date there is very little data, and not conducted in human subjects, on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies, and in particular how this affects profiles of platelet reactivity and thrombin generation. Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations, including coronary artery disease (CAD) and peripheral arterial disease (PAD), the study team proposes a prospective pharmacodynamic (PD) investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice.
Primary Outcome
Comparison of platelet-mediated global thrombogenicity measured by light transmittance aggregometry following collagen-related peptide+adenosine diphosphate+ tissue factor (CATF) stimuli between aspirin plus clopidogrel vs. aspirin plus clopidogrel plus rivaroxaban. This was reported as maximal aggregation %. The combination of agonists included in the CATF cocktail leads to activation of multiple platelet pathways including thrombin generation and is therefore a marker of thrombus formation med
Interventions
- DRUG Rivaroxaban 2.5 mg Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2019-01-14 |
| Est. Completion | 2020-08-30 |
| Phase | Phase 4 |
What the finished NCT03718429 record still lists
NCT03718429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Rivaroxaban 2.5 mg Tablet is the first listed.
NCT03718429 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03718429 about?
NCT03718429 is a clinical study titled "Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies". Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. To date there is very little data, and not conducted in human subjects, on the interplay between anti-Xa...
What is the current status of trial NCT03718429?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 86 participants. The study started on 2019-01-14. Estimated completion is 2020-08-30.
What interventions are being tested in trial NCT03718429?
The interventions under investigation include: Rivaroxaban 2.5 mg Tablet (DRUG).
Who is sponsoring clinical trial NCT03718429?
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 NCT03718429's enrollment target sits among peer trials
86 926th of 2000 higher than 1,073 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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