What is rivaroxaban studying for superficial vein thrombosis?

Rivaroxaban is being studied to compare full-dose treatment for 90 days with a lower dose for 45 days in adults with superficial vein thrombosis of the leg. Researchers want to evaluate the study plan and recruitment feasibility to prepare for a larger future trial. The Ottawa Hospital Research Institute is leading this research.

Who may be eligible for this superficial vein thrombosis clinical trial?

Adults 18 years and older with a recent diagnosis of superficial vein thrombosis in the lower leg may be eligible. The study is open to all genders but excludes those with recent blood clots, other blood thinner needs, or pregnancy. Please review eligibility criteria for more details.

Is there any cost to participate in this superficial vein thrombosis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for their own travel arrangements.

Actively Recruiting

Phase 2

Phase 3

Age: 18Years +

All Genders

ID06965998

A Pilot Randomized Double-Blinded Comparison of Full Treatment Dose Rivaroxaban for 90 Days to Prophylactic Dose Rivaroxaban for 45 Days in Patients With Lower Extremity Superficial Vein Thrombosis

Led by Ottawa Hospital Research Institute · Updated on 2025-08-11

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of rivaroxaban, a blood thinner, in adults with superficial vein thrombosis SVT of the leg. This pilot study aims to test the study plan and see if enough participants will join a larger trial. It includes a small group and is not designed to prove safety or effectiveness, but to measure recruitment rates over 12 months. Participants will be randomly assigned to one of two groups. One group receives full-dose rivaroxaban for 90 days, starting with 15mg twice daily for 21 days, then 20mg once daily for 69 days. The other group receives a lower dose of rivaroxaban for 45 days combined with placebo pills to keep the study blinded, followed by 45 days of placebo alone. During the study, participants will be monitored to see how many join each month and how well the study procedures work. Researchers will track outcomes over 12 months, including recruitment feasibility and secondary measures from the start of recruitment until the last participants follow-up. The study uses a randomized, double-blind design to evaluate these aspects.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult patients age 65 18 years old
Objectively confirmed diagnosis within 14 days of an acute symptomatic superficial vein thrombosis (SVT) of the lower extremities by standardized compression ultrasound
Anticoagulation for SVT is warranted as decided by clinicians
Able and willing to provide written informed consent

You will not qualify if you...

Other indications for therapeutic or prophylactic dose anticoagulation (e.g., atrial fibrillation, mechanical valve)
History of pulmonary embolism or deep vein thrombosis within 6 months of screening
More than 5 days of anticoagulant treatment for the current SVT
Requires aspirin over 100mg daily or other antiplatelet agents
Receiving systemic treatment with strong inhibitors of CYP 3A4 and P-gp (e.g., cobicistat, ketoconazole)
Active bleeding or recent clinically relevant non-major or major bleeding within 30 days
Recent severe head trauma or eye, spinal, or brain surgery within 90 days
Acute endocarditis
Low platelet count (below 50,000/uL), acute or chronic active hepatitis, or severe liver impairment
Creatinine clearance below 30 ml/min
Known contraindication to rivaroxaban
Participation in another interventional trial that may affect this study
Pregnant or breastfeeding
Known severe bleeding disorders
Life expectancy less than 3 months
Unstable medical or psychological conditions interfering with participation as judged by investigators

Research Team

Tzu-Fei Wang, MD,MPH

Miriam Kimpton, MD,MSc,FRCPC

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