Study of Rivaroxaban for CeREbral Venous Thrombosis
- Conditions
- Cerebral Venous Thrombosis
- Interventions
- Drug: Standard of care
- Registration Number
- NCT03178864
- Lead Sponsor
- University of British Columbia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care Standard of care Unfractionated heparin Low-molecular weight heparin (dalteparin, enoxaparin, tinzaparin) Warfarin Rivaroxaban Rivaroxaban Rivaroxaban
- Primary Outcome Measures
Name Time Method Composite rate of all-cause mortality, symptomatic intracranial bleeding, major extracranial bleeding 180 days Symptomatic intracranial bleeding is defined as a new symptomatic intracranial hemorrhage OR worsening existing intracranial hemorrhage with a \>33% change in hematoma volume, AND either an NIHSS score increase of 4 or more points, or a change in level of consciousness as per NIHSS item 1a, AND the clinical change is thought to be attributable to the hemorrhage.
Major extracranial bleeding is defined as bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobin by 20 g/L or more, leading to transfusion of 2 or more units of whole blood or red cells.
- Secondary Outcome Measures
Name Time Method All-cause mortality 180 days Death from any cause
Symptomatic intracranial bleeding 180 days Symptomatic intracranial bleeding is defined as a new symptomatic intracranial hemorrhage OR worsening existing intracranial hemorrhage with a \>33% change in hematoma volume, AND either an NIHSS score increase of 4 or more points, or a change in level of consciousness as per NIHSS item 1a, AND the clinical change is thought to be attributable to the hemorrhage.
Major extracranial bleeding 180 days Major extracranial bleeding is defined as bleeding in a critical area or organ, including intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a drop in hemoglobin by 20 g/L or more, leading to transfusion of 2 or more units of whole blood or red cells.
Recurrent venous thromboembolism 180 days or end of anticoagulation, whichever is sooner any thrombosis at a new site including cerebral venous thrombosis in a separate localization from index event
Major bleeding or clinically relevant non-major bleeding 180 days or end of anticoagulation, whichever is sooner A clinically relevant minor bleed is an acute or subacute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of: (a) a hospital admission for bleeding, or (b) a physician guided medical or surgical treatment for bleeding, or (c) a change in antithrombotic therapy (including interruption or discontinuation or study drug)
Partial or complete recanalization 180 or 365 days Partial or complete recanalization between baseline and last study venogram
Functional independence 365 days modified Rankin Scale 0-1
Reduced functional dependence 365 days shift of one or more modified Rankin Scale categories to reduced functional dependence
Health care resource utilization 365 days Cost in Canadian dollars of number of hospitalizations (length of stay, critical care unit use), emergency room visits, unscheduled outpatient consultations, postacute care (including home care, rehabilitation stays or long-term care)
Population Health Questionnaire (PHQ)-9 score 365 days Change in PHQ-9 score between baseline and end of study
EuroQOL 5-Dimensions (EQ-5D) score 365 days Change in EQ-5D score between baseline and end of study
Fatigue Assessment score 365 days Change in fatigue assessment score between baseline and end of study
Headache Impact Test - 6 score 365 days Change in Headache Impact Test - 6 score between baseline and Day 180 (score = 36-78, where a higher score indicates a worse outcome)
Montreal Cognitive Assessment score 365 days Change in performance on the Montreal Cognitive Assessment between baseline and end of study (score = 0-30, where a higher score indicates a better outcome)
National Institutes of Health toolbox - Cognitive battery score 365 days Change in performance on the cognitive battery of the National Institutes of Health toolbox between baseline and end of study (where a higher score indicates a better outcome)
Boston cookie theft picture description task 365 days Change in spontaneous speech between baseline and end of study. Components of spontaneous speech include lexical features (part-of-speech, word types and frequencies), syntactic complexity, grammaticality, fluency, vocabulary richness, and acoustic features.
Trial Locations
- Locations (11)
Kelowna General Hospital
🇨🇦Kelowna, British Columbia, Canada
Hamilton Health Sciences Centre
🇨🇦Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada