Study of Rivaroxaban for CeREbral Venous Thrombosis

  • STATUS
    Recruiting
  • End date
    Dec 25, 2021
  • participants needed
    50
  • sponsor
    University of British Columbia
Updated on 25 January 2021

Summary

SECRET examines the safety of rivaroxaban versus standard-of-care for treatment of symptomatic cerebral venous thrombosis, initiated within 14 days of diagnosis.

Description

SECRET is an open-label, randomized, controlled, phase II study that will assess the safety of rivaroxaban, a non-vitamin K antagonist oral anticoagulant (NOAC), compared with standard-of-care (unfractionated or low-molecular weight heparin with transition to warfarin [INR 2.0-3.0], or continued low molecular-weight heparin) for cerebral venous thrombosis. Recruitment will occur at 17 high-volume stroke research centres across Canada over 3 years. During the pilot phase, 50 adult patients within 14 days of symptomatic cerebral venous thrombosis diagnosis will be randomized to receive rivaroxaban 20 mg daily versus standard of care (warfarin or low-molecular weight heparin). Patients will be followed for 1 year. The feasibility of recruitment will be tested during the pilot phase and outcomes refined for a future Phase III trial.

Details
Condition Cerebral Venous Thrombosis
Treatment Rivaroxaban, Standard of Care
Clinical Study IdentifierNCT03178864
SponsorUniversity of British Columbia
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Cerebral Venous Thrombosis?
Do you have any of these conditions: Do you have Cerebral Venous Thrombosis??
Patients aged 18 and above
New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT venogram or MR venogram
Ability to randomize within 14 days of neuroimaging-confirmed diagnosis
The treating clinician is of the opinion that the patient is appropriate for oral anticoagulation as per standard of care
Patient or legally authorized representative is able to give written informed consent

Exclusion Criteria

Patient has known antiphospholipid antibody syndrome (APLS; lupus anticoagulant, anti-beta 2-glycoprotein I antibodies, and anticardiolipin antibody) by Sapporo-Sydney criteria with a previous history of venous or arterial thrombosis
Patient is anticipated to require invasive procedure (e.g. lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation
Patient is unable to swallow due to depressed level of consciousness
Impaired renal function (i.e., CrCl < 30 mL/min using Cockroft-Gault equation)
Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (-hCG) test is positive
Breastfeeding at the time of randomization
Bleeding diathesis or other contraindication to anticoagulation
Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)
Patient has a severe or fatal comorbid illness that will prevent improvement, or cannot complete follow-up due to the same, or cannot complete follow-up due to co-morbid non-fatal illness, non-residence in the city, or for any other known reason for which follow-up would be impossible
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