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Study of Rivaroxaban for CeREbral Venous Thrombosis (SECRET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178864
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Thalia Field, 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.

Condition or disease Intervention/treatment Phase
Cerebral Venous Thrombosis Drug: Rivaroxaban Drug: Standard of care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 12, 2019
Actual Primary Completion Date : October 5, 2022
Actual Study Completion Date : October 5, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rivaroxaban
Rivaroxaban
Drug: Rivaroxaban
Rivaroxaban 20 mg daily (15 mg daily in participants with a CrCl 30-49 mL/min as per the Cockroft-Gault equation)
Other Name: Xarelto

Active Comparator: Standard of care
Unfractionated heparin Low-molecular weight heparin (dalteparin, enoxaparin, tinzaparin) Warfarin
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.
Other Name: Heparin, Coumadin, Fragmin, Lovenox, Innohep




Primary Outcome Measures :
  1. Composite rate of all-cause mortality, symptomatic intracranial bleeding, major extracranial bleeding [ Time Frame: 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 :
  1. All-cause mortality [ Time Frame: 180 days ]
    Death from any cause

  2. Symptomatic intracranial bleeding [ Time Frame: 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.

  3. Major extracranial bleeding [ Time Frame: 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.

  4. Recurrent venous thromboembolism [ Time Frame: 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

  5. Major bleeding or clinically relevant non-major bleeding [ Time Frame: 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)

  6. Partial or complete recanalization [ Time Frame: 180 or 365 days ]
    Partial or complete recanalization between baseline and last study venogram

  7. Functional independence [ Time Frame: 365 days ]
    modified Rankin Scale 0-1

  8. Reduced functional dependence [ Time Frame: 365 days ]
    shift of one or more modified Rankin Scale categories to reduced functional dependence

  9. Health care resource utilization [ Time Frame: 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)

  10. Population Health Questionnaire (PHQ)-9 score [ Time Frame: 365 days ]
    Change in PHQ-9 score between baseline and end of study

  11. EuroQOL 5-Dimensions (EQ-5D) score [ Time Frame: 365 days ]
    Change in EQ-5D score between baseline and end of study

  12. Fatigue Assessment score [ Time Frame: 365 days ]
    Change in fatigue assessment score between baseline and end of study

  13. Headache Impact Test - 6 score [ Time Frame: 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)

  14. Montreal Cognitive Assessment score [ Time Frame: 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)

  15. National Institutes of Health toolbox - Cognitive battery score [ Time Frame: 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)

  16. Boston cookie theft picture description task [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178864


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Kelowna General Hospital
Kelowna, British Columbia, Canada, V1Y 1T2
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 2X2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Centre hospitalier de l'Université de Montréal
Montréal, Quebec, Canada
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Thalia S Field, MD FRCPC University of British Columbia
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Responsible Party: Thalia Field, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03178864    
Other Study ID Numbers: H17-00440
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon completion of the SECRET Trial, a public use database will be prepared by stripping any and all personal identifiers. The public use database, consisting of several data files, should contain: (1) baseline and demographic characteristics; (2) outcomes assessments; (3) CT/MRI data; (4) concomitant medications and procedures; and (5) adverse events. Each data file is made available as a formatted SAS dataset or other electronic format. The data files are distributed along with the data dictionary and a brief instruction ("Readme") file. These data files will be made available to the public only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thalia Field, University of British Columbia:
cerebral venous thrombosis
anticoagulation
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin
Rivaroxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors