A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective different doses of a blood-thinning medication called rivaroxaban are for treating superficial vein thrombosis (SVT), which is a blood clot in the superficial veins of the leg. Participants will be divided into two groups: one group will receive a lower dose of rivaroxaban for 45 days, followed by a placebo (a harmless pill with no active ingredients) for another 45 days, while the other group will take a full dose of rivaroxaban for a total of 90 days. The trial aims to recruit enough participants to see if it is feasible to conduct a larger study in the future.

To be eligible for this trial, participants need to be adults aged 18 or older who have been diagnosed with an SVT within the last 14 days. They must also be approved by their healthcare provider to receive treatment with blood thinners. However, certain people, such as those with a history of severe bleeding, recent surgeries, or specific health conditions, will not be able to participate. If you or a loved one qualifies, you can expect to take the medication as directed and attend follow-up appointments to monitor your health during the study. It's important to know that this trial is not yet recruiting participants, but it will be essential for understanding the treatment options for SVT in the future.

Gender

ALL

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.