RecruitingPhase 2Phase 3NCT06965998

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

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


Sponsor

Ottawa Hospital Research Institute

Enrollment

50 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Full dose rivaroxaban, a drug called Low dose rivaroxaban, and others for people with svt, superficial vein thrombosis, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFull dose rivaroxaban

The intervention group will receive full dose rivaroxaban for 90 days.

DRUGLow dose rivaroxaban

The comparator group will receive the standard treatment of low dose rivaroxaban.

DRUGPlacebo

Since the treatment arm has an AM and PM dose of study drug from Day 1-21, the comparator group will take 1 placebo pill in the PM to keep the two arms blinded.


Locations(2)

The Ottawa Hospital

Ottawa, Ontario, Canada

Hopital Montfort

Ottawa, Ontario, Canada

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NCT06965998


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