Controversies in venous thromboembolism: to treat or not to treat superficial vein thrombosis.
Jan Beyer-Westendorf
https://pubmed.ncbi.nlm.nih.gov/29222259/Actively Recruiting
Led by Ottawa Hospital Research Institute · Updated on 2025-08-11
50
Participants Needed
2
Research Sites
26 weeks
Total Duration
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
A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
T
Tzu-Fei Wang, MD,MPH
M
Miriam Kimpton, MD,MSc,FRCPC
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Ottawa Hospital Research Institute
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Up to 90 days depending on treatment group
Participants receive either full dose or low dose rivaroxaban according to their assigned group.
Multiple visits during treatment period for medication administration and monitoring
Duration - Up to 6 months after treatment ends
Participants are monitored for treatment outcomes and safety after treatment completion.
Several follow-up visits to assess health status and any complications
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor