Actively Recruiting
A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
Led by Ottawa Hospital Research Institute · Updated on 2025-08-11
50
Participants Needed
2
Research Sites
77 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older
- Confirmed diagnosis of acute symptomatic superficial vein thrombosis (SVT) in lower extremities within 14 days by standardized ultrasound
- Anticoagulation treatment for SVT recommended by clinicians
- Able and willing to provide written informed consent
You will not qualify if you...
- Need for anticoagulation for other reasons such as atrial fibrillation or mechanical heart valve
- History of pulmonary embolism or deep vein thrombosis within 6 months before screening
- More than 5 days of anticoagulant treatment for the current SVT
- Use of aspirin over 100mg daily or other antiplatelet drugs
- Treatment with strong inhibitors of CYP 3A4 and P-gp enzymes (e.g., cobicistat, ketoconazole)
- Active bleeding or history of clinically relevant non-major or major bleeding within 30 days
- Severe head trauma or eye, spinal, or brain surgery within 90 days
- Acute endocarditis
- Low platelet count (under 50,000/uL), acute or chronic active hepatitis, or severe liver disease
- Kidney function with creatinine clearance under 30 ml/min
- Known allergy or contraindication to rivaroxaban
- Participation in another interventional trial that might affect this study
- Pregnant or breastfeeding
- Known severe bleeding disorders
- Life expectancy less than 3 months
- Unstable medical or psychological conditions that interfere with study participation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
2
Hopital Montfort
Ottawa, Ontario, Canada, K1K 0T2
Not Yet Recruiting
Research Team
T
Tzu-Fei Wang, MD,MPH
CONTACT
M
Miriam Kimpton, MD,MSc,FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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