Study of Rivaroxaban for CeREbral Venous Thrombosis

NCT ID: NCT03178864

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2022-10-05

Brief Summary

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

Detailed 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.

Conditions

Cerebral Venous Thrombosis

Keywords

cerebral venous thrombosis; anticoagulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rivaroxaban

Rivaroxaban

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

Rivaroxaban 20 mg daily (15 mg daily in participants with a CrCl 30-49 mL/min as per the Cockroft-Gault equation)

Standard of care

Unfractionated heparin Low-molecular weight heparin (dalteparin, enoxaparin, tinzaparin) Warfarin

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: DRUG

Accepted standard of care as per American Heart Association/American Stroke Association Guidelines (initial use of unfractionated heparin or low-molecular weight heparin with transition to an oral vitamin K antagonist or continuation with low-molecular weight heparin) with choice of agent at the treating physician's discretion.

Interventions

Rivaroxaban

Rivaroxaban 20 mg daily (15 mg daily in participants with a CrCl 30-49 mL/min as per the Cockroft-Gault equation)

Intervention Type: DRUG

Standard of care

Accepted standard of care as per American Heart Association/American Stroke Association Guidelines (initial use of unfractionated heparin or low-molecular weight heparin with transition to an oral vitamin K antagonist or continuation with low-molecular weight heparin) with choice of agent at the treating physician's discretion.

Intervention Type: DRUG

Other Intervention Names

Xarelto; Heparin, Coumadin, Fragmin, Lovenox, Innohep

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Thalia Field

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thalia S Field, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

Kelowna General Hospital

Kelowna, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

Field TS, Dizonno V, Almekhlafi MA, Bala F, Alhabli I, Wong H, Norena M, Villaluna MK, King-Azote P, Ratnaweera N, Mancini S, Van Gaal SC, Wilson LK, Graham BR, Sposato LA, Blacquiere D, Dewar BM, Boulos MI, Buck BH, Odier C, Perera KS, Pikula A, Tkach A, Medvedev G, Canfield C, Mortenson WB, Nadeau JO, Alshimemeri S, Benavente OR, Demchuk AM, Dowlatshahi D, Lanthier S, Lee AYY, Mandzia J, Suryanarayan D, Weitz JI, Hill MD; SECRET Investigators. Study of Rivaroxaban for Cerebral Venous Thrombosis: A Randomized Controlled Feasibility Trial Comparing Anticoagulation With Rivaroxaban to Standard-of-Care in Symptomatic Cerebral Venous Thrombosis. Stroke. 2023 Nov;54(11):2724-2736. doi: 10.1161/STROKEAHA.123.044113. Epub 2023 Sep 7.

Reference Type: DERIVED

PMID: 37675613 (View on PubMed)

Other Identifiers

H17-00440

Identifier Type: -

Identifier Source: org_study_id