NCT06965998

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 thinner that is used in the treatment and prevention of blood clots. Currently, rivaroxaban 10mg daily for 45 days is the most commonly used treatment in patients with lower extremity SVT. Recent studies of participants with SVT suggest that treatment with full-dose (sometimes called therapeutic dose) blood thinners could be promising in preventing additional complications from SVT such as: * A new blood clot in the deep veins of the legs or arms * A new pulmonary embolism (a blood clot in the lungs) * A recurrence or extension of the existing SVT (the existing clot comes back after treatment is stopped or gets bigger) The Investigators are studying whether a full-dose of rivaroxaban for 90 days could prevent or improve additional complications from SVT.

Conditions

• SVT
• Thrombosis
• Superficial Vein Thrombosis

Interventions

Type	Name	Description
DRUG	Full dose rivaroxaban	The intervention group will receive full dose rivaroxaban for 90 days.
DRUG	Low dose rivaroxaban	The comparator group will receive the standard treatment of low dose rivaroxaban.
DRUG	Placebo	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.

Timeline

• Start date: 2025-08-06
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2025-05-11
• Last updated: 2025-08-11

Locations

2 sites across 1 country: Canada