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Phase 2
Phase 3
Age: 18Years +
All Genders
ID06965998

Pilot Study Comparing Full Dose Rivaroxaban for 90 Days to Low Dose Rivaroxaban for 45 Days in Adults With Superficial Vein Thrombosis of the Leg

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

50

Participants Needed

2

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

Research Team

T

Tzu-Fei Wang, MD,MPH

M

Miriam Kimpton, MD,MSc,FRCPC

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