Rivaroxaban for Blood Clots

(RIVA-SVT Trial)

Recruiting at 1 trial location

Overseen By Tzu-Fei Wang, MD,MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Ottawa Hospital Research Institute

Must be taking: Anticoagulants

Must not be taking: Antiplatelets, CYP3A4 inhibitors

Disqualifiers: Atrial fibrillation, PE, DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Tzu-Fei Wang, MD,MPH

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for adults with superficial vein thrombosis (SVT) in the leg. Participants must be willing to take a blood thinner called rivaroxaban and agree to potentially receive a placebo. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either full-dose or prophylactic-dose rivaroxaban for up to 90 days

90 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Rivaroxaban

Trial Overview The study compares full-dose rivaroxaban against low-dose followed by placebo, over a period of 90 days, to see if enough people will join and follow the larger study plan. It's an early-stage trial that won't confirm safety or effectiveness yet.

Participant Groups

Group I: Group A (Intervention) Experimental Treatment 1 Intervention

Day 1-21: 15mg Rivaroxaban twice per day Day 22-90: 20mg Rivaroxaban once a day for 69 days

Group II: Group B (Comparator) Active Control 1 Intervention

Day 1-21: 10mg Rivaroxaban once a day AND placebo once a day Day 22-45: 10mg Rivaroxaban once a day Day 46-90: Placebo once a day for 45 days

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+