Phase
Condition
Venous Thrombosis
Claudication
Venous Thromboembolism
Treatment
Low dose rivaroxaban and placebo
Full dose rivaroxaban
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patients age ≥ 18 years old.
Objectively confirmed diagnosis within 14 days of an acute symptomatic SVT of thelower extremities by standardized CUS, where SVT is defined as incompressibility ofa venous segment located along the course of a known superficial vein.
Anticoagulation for SVT is warranted per clinicians.
Able and willing to provide written informed consent.
Exclusion
Exclusion Criteria:
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 daysof screening.
Have acute endocarditis.
Thrombocytopenia (platelet count <50,000/uL), acute hepatitis, chronic activehepatitis, cirrhosis with severe hepatic impairment defined by a Childs-Pugh class Bor C.
Creatinine clearance <30 ml/min.
Known contraindication to treatment with rivaroxaban.
Are participating in another interventional trial that would compromise the resultsor 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 trialparticipation at the discretion of the site investigator.
Study Design
Study Description
Connect with a study center
Hopital Montfort
Ottawa, Ontario K1K 0T2
CanadaSite Not Available
The Ottawa Hospital
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.