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Compares treatment options for SVT
Official title A Pilot Trial Comparing Full Dose Rivaroxaban to Prophylactic Dose Rivaroxaban in Patients With Superficial Vein Thrombosis in the Leg
ClinicalTrials.gov ID: NCT06965998
What this study is testing
What is Full dose rivaroxaban?
Full dose rivaroxaban is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for svt.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients age ≥ 18 years old.
- Objectively confirmed diagnosis within 14 days of an acute symptomatic SVT of the lower extremities by standardized CUS, where SVT is defined as...
- Anticoagulation for SVT is warranted per clinicians.
- Able and willing to provide written informed consent.
You likely can't join if
- Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.).
- History of PE or DVT within 6 months (180 days) of screening.
- \>5 days of any anticoagulants for the index SVT.
- Requires use of aspirin \>100mg daily or other antiplatelet agents.
- Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole...
- Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening.
See the full eligibility criteria
- Adult patients age ≥ 18 years old.
- 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...
- Anticoagulation for SVT is warranted per clinicians.
- Able and willing to provide written informed consent.
- Other indication(s) for therapeutic or prophylactic dose anticoagulation (e.g. atrial fibrillation, mechanical valve, etc.).
- History of PE or DVT within 6 months (180 days) of screening.
- \>5 days of any anticoagulants for the index SVT.
- Requires use of aspirin \>100mg daily or other antiplatelet agents.
- Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (e.g. cobicistat, ketoconazole, itraconazole, posaconazole, ritanovir, etc.).
- Active bleeding or history of CRNMB or major bleeding (as defined by the ISTH) within 30 days of screening.
- History of severe head trauma or ophthalmic, spinal, cerebral surgery within 90 days of screening.
- Have acute endocarditis.
- Thrombocytopenia (platelet count \<50,000/uL), acute hepatitis, chronic active hepatitis, cirrhosis with severe hepatic impairment defined by a Childs-Pugh class B or C.
- Creatinine clearance \<30 ml/min.
- Known contraindication to treatment with rivaroxaban.
- Are participating in another treatment trial that would compromise the results or integrity of this trial as determined by the investigator.
- Pregnant or breast feeding.
- Known hereditary or acquired severe hemorrhagic disease.
- Life expectancy \<3 months.
- Unstable medical or psychological condition that would interfere with trial participation at the discretion of the site investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.