Status:
RECRUITING
A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
SVT
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 proced...
Detailed Description
The standard or usual treatment for a superficial vein thrombosis (SVT) is to treat with a low-dose (often called a prophylactic dose) of blood thinner for 45 days. Rivaroxaban is a type of oral blood...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06965998
Start Date
August 6 2025
End Date
February 1 2027
Last Update
August 11 2025
Active Locations (2)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
2
Hopital Montfort
Ottawa, Ontario, Canada, K1K 0T2