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NCT02072668 · ClinicalTrials.gov registry record · Phase 2
The Effect of Rivaroxaban in Sickle Cell Disease
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02072668 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants.
The verdict
NCT02072668, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce inflammation, coagulation and endothelial cell activation, and improve microvascular blood flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test this hypothesis, this study will evaluate the effects of rivaroxaban on: * plasma markers of inflammation; * plasma markers of endothelial activation; * plasma markers of thrombin generation; and * microvascular blood flow assessed using laser Doppler velocimetry (LDV) of post-occlusive reactive hyperemia (PORH). In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks each, separated by a 2-week washout phase.
Interventions
- DRUG placebo
- DRUG rivaroxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-10-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02072668
The ClinicalTrials.gov registry entry for NCT02072668 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02072668 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02072668 about?
NCT02072668 is a clinical study titled "The Effect of Rivaroxaban in Sickle Cell Disease". The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce inflammation, coagulation and endothelial cell activation, and improve microvascular blood flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test this hypothesis, this stud...
What is the current status of trial NCT02072668?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2014-02. Estimated completion is 2018-10-04.
What interventions are being tested in trial NCT02072668?
The interventions under investigation include: placebo (DRUG), rivaroxaban (DRUG).
Who is sponsoring clinical trial NCT02072668?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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