Cerebral Venous Thrombosis Clinical Trial
— SECRETOfficial title:
Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Early Anticoagulation With Rivaroxaban Versus Standard of Care in Determining Safety at 365 Days in Symptomatic Cerebral Venous Thrombosis
Verified date | December 2022 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
SECRET examines the safety of rivaroxaban versus standard-of-care for treatment of symptomatic cerebral venous thrombosis, initiated within 14 days of diagnosis.
Status | Completed |
Enrollment | 55 |
Est. completion date | October 5, 2022 |
Est. primary completion date | October 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 (ß-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. |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Hamilton Health Sciences Centre | Hamilton | Ontario |
Canada | Kelowna General Hospital | Kelowna | British Columbia |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Centre hospitalier de l'Université de Montréal | Montréal | Quebec |
Canada | The Ottawa Hospital Research Institute | Ottawa | Ontario |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Toronto Western Hospital | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite rate of all-cause mortality, symptomatic intracranial bleeding, major extracranial bleeding | 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. |
180 days | |
Secondary | All-cause mortality | Death from any cause | 180 days | |
Secondary | Symptomatic intracranial bleeding | 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. | 180 days | |
Secondary | Major extracranial bleeding | 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. | 180 days | |
Secondary | Recurrent venous thromboembolism | any thrombosis at a new site including cerebral venous thrombosis in a separate localization from index event | 180 days or end of anticoagulation, whichever is sooner | |
Secondary | Major bleeding or clinically relevant non-major bleeding | 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) | 180 days or end of anticoagulation, whichever is sooner | |
Secondary | Partial or complete recanalization | Partial or complete recanalization between baseline and last study venogram | 180 or 365 days | |
Secondary | Functional independence | modified Rankin Scale 0-1 | 365 days | |
Secondary | Reduced functional dependence | shift of one or more modified Rankin Scale categories to reduced functional dependence | 365 days | |
Secondary | Health care resource utilization | 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) | 365 days | |
Secondary | Population Health Questionnaire (PHQ)-9 score | Change in PHQ-9 score between baseline and end of study | 365 days | |
Secondary | EuroQOL 5-Dimensions (EQ-5D) score | Change in EQ-5D score between baseline and end of study | 365 days | |
Secondary | Fatigue Assessment score | Change in fatigue assessment score between baseline and end of study | 365 days | |
Secondary | Headache Impact Test - 6 score | Change in Headache Impact Test - 6 score between baseline and Day 180 (score = 36-78, where a higher score indicates a worse outcome) | 365 days | |
Secondary | Montreal Cognitive Assessment score | 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) | 365 days | |
Secondary | National Institutes of Health toolbox - Cognitive battery score | 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) | 365 days | |
Secondary | Boston cookie theft picture description task | 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. | 365 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00924859 -
The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)
|
||
Recruiting |
NCT03747081 -
Efficacy Comparison of Warfarin Versus Rivaroxaban CVT
|
Phase 1/Phase 2 | |
Recruiting |
NCT03217448 -
The Efficacy and Safety of Dabigatran Etexilate for the Treatment of Cerebral Venous Thrombosis
|
Phase 3 | |
Recruiting |
NCT04660747 -
Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis
|
||
Recruiting |
NCT04972058 -
Philippine Neurological Association One Database - Stroke
|
||
Completed |
NCT02013635 -
Thrombin Generation and Thrombus Degradation in Cerebral Venous Thrombosis : Clinical and Radiological Correlations
|
N/A | |
Completed |
NCT06266585 -
Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study
|
||
Completed |
NCT05990894 -
Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.
|
||
Completed |
NCT03033966 -
Evaluation of Cerebral Oxygenation and Hemodynamics in Patients With Cerebral Venous Thrombosis
|
N/A | |
Not yet recruiting |
NCT03191305 -
Comparison of the Efficacy of Rivroxaban to Coumadin( Warfarin ) in Cerebral Venous Thrombosis
|
N/A | |
Recruiting |
NCT05491980 -
Florida Cerebrovascular Disease Biorepository and Genomics Center
|
||
Completed |
NCT01796015 -
Intracranial Hypertension and Optic Nerve Sheath Diameter
|
N/A |