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 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.

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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Page 1 of 1 (2 locations)

1

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

2

Hopital Montfort

Ottawa, Ontario, Canada, K1K 0T2