Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06965998

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

Led by Ottawa Hospital Research Institute · Updated on 2025-08-11

50

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of rivaroxaban, a blood thinner, in adults with superficial vein thrombosis (SVT) of the leg. This pilot study aims to test the study plan and see if enough participants will join a larger trial. It includes a small group and is not designed to prove safety or effectiveness, but to measure recruitment rates over 12 months. Participants will be randomly assigned to one of two groups. One group receives full-dose rivaroxaban for 90 days, starting with 15mg twice daily for 21 days, then 20mg once daily for 69 days. The other group receives a lower dose of rivaroxaban for 45 days combined with placebo pills to keep the study blinded, followed by 45 days of placebo alone. During the study, participants will be monitored to see how many join each month and how well the study procedures work. Researchers will track outcomes over 12 months, including recruitment feasibility and secondary measures from the start of recruitment until the last participant's follow-up. The study uses a randomized, double-blind design to evaluate these aspects.

CONDITIONS

Brief Title

A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients age 65 18 years old
  • Objectively confirmed diagnosis within 14 days of an acute symptomatic superficial vein thrombosis (SVT) of the lower extremities by standardized compression ultrasound
  • Anticoagulation for SVT is warranted as decided by clinicians
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Other indications for therapeutic or prophylactic dose anticoagulation (e.g., atrial fibrillation, mechanical valve)
  • History of pulmonary embolism or deep vein thrombosis within 6 months of screening
  • More than 5 days of anticoagulant treatment for the current SVT
  • Requires aspirin over 100mg daily or other antiplatelet agents
  • Receiving systemic treatment with strong inhibitors of CYP 3A4 and P-gp (e.g., cobicistat, ketoconazole)
  • Active bleeding or recent clinically relevant non-major or major bleeding within 30 days
  • Recent severe head trauma or eye, spinal, or brain surgery within 90 days
  • Acute endocarditis
  • Low platelet count (below 50,000/uL), acute or chronic active hepatitis, or severe liver impairment
  • Creatinine clearance below 30 ml/min
  • Known contraindication to rivaroxaban
  • Participation in another interventional trial that may affect this study
  • Pregnant or breastfeeding
  • Known severe bleeding disorders
  • Life expectancy less than 3 months
  • Unstable medical or psychological conditions interfering with participation as judged by investigators

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and consent

Treatment

Duration - Up to 90 days depending on treatment group

Participants receive either full dose or low dose rivaroxaban according to their assigned group.

Multiple visits during treatment period for medication administration and monitoring

Follow-up

Duration - Up to 6 months after treatment ends

Participants are monitored for treatment outcomes and safety after treatment completion.

Several follow-up visits to assess health status and any complications

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

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Research Team

T

Tzu-Fei Wang, MD,MPH

M

Miriam Kimpton, MD,MSc,FRCPC

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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Frequently Asked Questions

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Published Research Related To This Trial

Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised, non-inferiority SURPRISE phase 3b trial.

Jan Beyer-Westendorf, Sebastian M Schellong, Horst Gerlach...

https://pubmed.ncbi.nlm.nih.gov/28219692

Treatment of superficial vein thrombosis to prevent deep vein thrombosis and pulmonary embolism: a systematic review.

Iris M Wichers, Marcello Di Nisio, Harry R Büller...

https://pubmed.ncbi.nlm.nih.gov/15921382

Prevalence of deep vein thrombosis and pulmonary embolism in patients with superficial vein thrombosis: a systematic review and meta-analysis.

M N D Di Minno, P Ambrosino, F Ambrosini...

https://pubmed.ncbi.nlm.nih.gov/26845754

Incidence of superficial venous thrombosis in primary care and risk of subsequent venous thromboembolic sequelae: a retrospective cohort study performed with routine healthcare data from the Netherlands.

Geert-Jan Geersing, Selma Cazemier, Frans Rutten...

https://pubmed.ncbi.nlm.nih.gov/29678975