A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
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
Ottawa Hospital Research Institute
50 participants
Aug 6, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Adult patients age ≥ 18 years old.
- 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.
- Anticoagulation for SVT is warranted per clinicians.
- Able and willing to provide written informed consent.
Exclusion Criteria16
- Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.).
- History of PE or DVT within 6 months (180 days) of screening.
- \>5 days of any anticoagulants for the index SVT.
- Requires use of aspirin \>100mg daily or other antiplatelet agents.
- Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritanovir, etc.).
- Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening.
- History of severe head trauma or ophthalmic, spinal, cerebral surgery within 90 days of screening.
- Have acute endocarditis.
- 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.
- Creatinine clearance \<30 ml/min.
- Known contraindication to treatment with rivaroxaban.
- Are participating in another interventional trial that would compromise the results or integrity of this trial as determined by the investigator.
- Pregnant or breast feeding.
- Known hereditary or acquired severe hemorrhagic disease.
- Life expectancy \<3 months.
- Unstable medical or psychological condition that would interfere with trial participation at the discretion of the site investigator.
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Interventions
The intervention group will receive full dose rivaroxaban for 90 days.
The comparator group will receive the standard treatment of low dose rivaroxaban.
Since the treatment arm has an AM and PM dose of study drug from Day 1-21, the comparator group will take 1 placebo pill in the PM to keep the two arms blinded.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06965998