Study of Rivaroxaban for CeREbral Venous Thrombosis

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Calcium heparin; Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Rivaroxaban

Criteria

Inclusion criteria:

1. Patients aged 18 and above

2. New diagnosis of symptomatic cerebral venous thrombosis as confirmed on CT venogram or MR venogram

3. Ability to randomize within 14 days of neuroimaging-confirmed diagnosis

4. The treating clinician is of the opinion that the patient is appropriate for oral anticoagulation as per standard of care

5. Patient or legally authorized representative is able to give written informed consent

Exclusion criteria:

1. 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

2. Patient is anticipated to require invasive procedure (e.g. lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation**

3. Patient is unable to swallow due to depressed level of consciousness†

4. Impaired renal function (i.e., CrCl < 30 mL/min using Cockroft-Gault equation)

5. Pregnancy; if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive

6. Breastfeeding at the time of randomization

7. Bleeding diathesis or other contraindication to anticoagulation

8. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use

9. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, ketoconazole)

10. 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.