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

Study acronym: RIVA-SVT
StatusRecruiting
PhasePhase 2/3
Started2025-08-06
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 11, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-08-05
notable
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-03→2026-08
Completion date2027-09→2027-02
Start dateestimated 2025-07→confirmed 2025-08-06
InterventionsFull dose rivaroxaban (Drug), Low dose rivaroxaban and placebo (Drug)→Full dose rivaroxaban (Drug), Low dose rivaroxaban (Drug), Placebo (Drug)
Secondary endpoints1 to 4 entries
Secondary Feasibility Outcomes Secondary Feasibility Outcomes Secondary Feasibility Outcomes
Study sitesdetails revised at 2 of 2 sites
2025-05-02
minor
Original filing
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.
Trial Details
NCT Number NCT06965998
Lead Sponsor Ottawa Hospital Research Institute
Conditions SVT, Thrombosis, Superficial Vein Thrombosis
Enrollment 50 participants
Start Date 2025-08-06
Primary Completion 2026-08 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-11