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Study of Rivaroxaban for CeREbral Venous Thrombosis (SECRET)

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ClinicalTrials.gov Identifier: NCT03178864
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : April 16, 2019
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. Three hundred and eighty adult patients within 14 days of diagnosis of symptomatic cerebral venous thrombosis will be randomized to receive rivaroxaban 20 mg daily versus standard of care (regimen at the discretion of the local investigator in keeping with AHA/ASA guidelines). Patients will be followed for 1 year. The feasibility of recruitment will also be tested.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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 GFR of <50 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 ]
    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 ]
    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 days ]
    Partial or complete recanalization between baseline and last study venogram

  7. Functional independence [ Time Frame: 180 days ]
    modified Rankin Scale 0-1

  8. Reduced functional dependence [ Time Frame: 180 days ]
    shift of one or more modified Rankin Scale categories to reduced functional dependence

  9. Health care resource utilization [ Time Frame: 180 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: 180 days ]
    Change in PHQ-9 score between baseline and end of study

  11. EuroQOL 5-Dimensions (EQ-5D) score [ Time Frame: 180 days ]
    Change in EQ-5D score between baseline and end of study

  12. Fatigue Assessment score [ Time Frame: 180 days ]
    Change in fatigue assessment score between baseline and end of study



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 is anticipated to require invasive procedure (e.g., lumbar puncture, thrombectomy, hemicraniectomy) prior to initiation of oral anticoagulation
  2. Patient is unable to swallow due to depressed level of consciousness
  3. Impaired renal function (CrCl < 30 mL/min using Cockroft-Gault equation)
  4. Pregnancy - if a woman is of childbearing potential a urine or serum beta human chorionic gonadotropin (β-hCG) test is positive
  5. Breastfeeding at the time of randomization
  6. Bleeding diathesis or other contraindication to anticoagulation
  7. Any concurrent medical condition requiring mandatory antiplatelet or anticoagulant use
  8. Concomitant use of strong CYP3A4 inducers (e.g., ongoing use of dilantin, carbamazepine, HIV protease inhibitors) or CYP3A4 inhibitors (e.g., diltiazem, systemic ketoconazole)
  9. 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


Contacts
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Contact: Thalia S Field, MD FRCPC 604-875-4554 thalia.field@ubc.ca
Contact: Vanessa Dizonno 604-875-4111 ext 67814 vanessa.dizonno@ubc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Vanessa Dizonno, MSc    6048754111 ext 67814    vanessa.dizonno@ubc.ca   
Principal Investigator: Laura Wilson, MD         
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     History of Changes
Other Study ID Numbers: H17-00440
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
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
Calcium heparin
Rivaroxaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors