Full-dose versus low-dose rivaroxaban for superficial vein clots in the leg

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized pilot comparing therapeutic (full)‑dose rivaroxaban for 90 days to the common low (prophylactic) dose given for 45 days followed by 45 days of placebo in adults with ultrasound‑confirmed superficial vein thrombosis (SVT) of the lower limb. The trial enrolls adults diagnosed within 14 days and randomizes them to one of the two treatment strategies to test feasibility and study procedures. The primary operational question is the average monthly recruitment rate over a 12‑month period rather than definitive efficacy. Safety and signal outcomes will be monitored, but the study is not powered to prove superiority for clinical endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult patients age ≥ 18 years old.
2. 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.
3. Anticoagulation for SVT is warranted per clinicians.
4. Able and willing to provide written informed consent.

Exclusion Criteria:

1. Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.).
2. History of PE or DVT within 6 months (180 days) of screening.
3. \>5 days of any anticoagulants for the index SVT.
4. Requires use of aspirin \>100mg daily or other antiplatelet agents.
5. Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritanovir, etc.).
6. Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening.
7. History of severe head trauma or ophthalmic, spinal, cerebral surgery within 90 days of screening.
8. Have acute endocarditis.
9. 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.
10. Creatinine clearance \<30 ml/min.
11. Known contraindication to treatment with rivaroxaban.
12. Are participating in another interventional trial that would compromise the results or integrity of this trial as determined by the investigator.
13. Pregnant or breast feeding.
14. Known hereditary or acquired severe hemorrhagic disease.
15. Life expectancy \<3 months.
16. Unstable medical or psychological condition that would interfere with trial participation at the discretion of the site investigator.

Where it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• Hopital Montfort
  Ottawa, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Tzu-Fei Wang, MD,MPH — Ottawa Hospital Research Institute
• Study coordinator: Tzu-Fei Wang, MD,MPH
• Email: tzwang@toh.ca
• Phone: 613-737-9988

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.