NCT06965998 A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
| NCT ID | NCT06965998 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | SVT |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-08-06 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial, called a pilot study or a feasibility study, is to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. This type of study includes a small number of participants so it is not expected to prove how safe the treatment is or how well the treatment works. The main question it hopes to answer is: 1.What is the average number of patients that are recruited per month during the 12 month study period? To test the study plan, adults being treated for a superficial vein thrombosis (SVT), which is a blood clot in the superficial veins of the leg, will be given a type of blood thinner called rivaroxaban. Half of the participants in this study will be given the standard (low-dose) rivaroxaban for 45 days, then 45 days of placebo (a substance that looks like the study medication but does not have any active or medicinal ingredients). The other half of participants will be given full-dose rivaroxaban for a total of 90 days. The placebo in this study is not intended to have any effect on the participants blood clot. A placebo is used to make the results of the study more reliable.
Eligibility Criteria
Inclusion Criteria: 1. Adult patients age ≥ 18 years old. 2. Objectively confirmed diagnosis within 14 days of an acute symptomatic SVT of the lower extremities by standardized CUS, where SVT is defined as incompressibility of a venous segment located along the course of a known superficial vein. 3. Anticoagulation for SVT is warranted per clinicians. 4. Able and willing to provide written informed consent. Exclusion Criteria: 1. Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.). 2. History of PE or DVT within 6 months (180 days) of screening. 3. \>5 days of any anticoagulants for the index SVT. 4. Requires use of aspirin \>100mg daily or other antiplatelet agents. 5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritanovir, etc.). 6. Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening. 7. History of severe head trauma or ophthalmic, spinal, cerebral surgery within 90 days of screening. 8. Have acute endocarditis. 9. Thrombocytopenia (platelet count \<50,000/uL), acute hepatitis, chronic active hepatitis, cirrhosis with severe hepatic impairment defined by a Childs-Pugh class B or C. 10. Creatinine clearance \<30 ml/min. 11. Known contraindication to treatment with rivaroxaban. 12. Are participating in another interventional trial that would compromise the results or integrity of this trial as determined by the investigator. 13. Pregnant or breast feeding. 14. Known hereditary or acquired severe hemorrhagic disease. 15. Life expectancy \<3 months. 16. Unstable medical or psychological condition that would interfere with trial participation at the discretion of the site investigator.
Contact & Investigator
Tzu-Fei Wang, MD,MPH
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT06965998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SVT. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06965998 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06965998 currently recruiting?
Yes, NCT06965998 is actively recruiting participants. Contact the research team at tzwang@toh.ca for enrollment information.
Where is the NCT06965998 trial being conducted?
This trial is being conducted at Ottawa, Canada, Ottawa, Canada.
Who is sponsoring the NCT06965998 clinical trial?
NCT06965998 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Tzu-Fei Wang, MD,MPH at Ottawa Hospital Research Institute. The trial plans to enroll 50 participants.