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Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease

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ClinicalTrials.gov Identifier: NCT04142125
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
CATIS-ICAD is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Intracranial Atherosclerotic Disease Drug: Rivaroxaban 2.5 Mg Oral Tablet bid Drug: Acetylsalicyclic acid 81 mg tablet qd Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: investigator-initiated, open-label, blinded endpoint assessment, controlled, randomized pilot trial (PROBE design)
Masking: Single (Outcomes Assessor)
Masking Description: Blinded assessment of endpoint
Primary Purpose: Treatment
Official Title: Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental (riva + ASA)
Rivaroxaban 2.5mg bid + aspirin 81mg qd
Drug: Rivaroxaban 2.5 Mg Oral Tablet bid
Pts will receive rivaroxaban + aspirin
Other Name: Xarelto

Drug: Acetylsalicyclic acid 81 mg tablet qd
Pts will receive ASA
Other Name: Aspirin

Active Comparator: Control (ASA alone)
Aspirin 81 mg qd
Drug: Acetylsalicyclic acid 81 mg tablet qd
Pts will receive ASA
Other Name: Aspirin




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: From randomization to end of recruitment (2 years) ]
    Recruitment rate of potentially eligible patients from neurology clinics

  2. Refusal rate [ Time Frame: From randomization to end of recruitment (2 years) ]
    Rate of patients who refuse to participate in the clinical trial who otherwise are eligible for the study

  3. Retention rate [ Time Frame: From randomization to End of Study (median 2 years) ]
    Rate of patients who remain in the clinical trial until EOS or qualifying event

  4. Incidence rate of Intracranial hemorrhage [ Time Frame: From randomization to End of Study (median 2 years) ]
    Rate of patients who experience an intracranial hemorrhage during the study


Secondary Outcome Measures :
  1. Major hemorrhage [ Time Frame: From randomization to End of Study (median 2 years) ]
    Major hemorrhage as defined by ISTH criteria

  2. Combination of ISTH major hemorrhages & clinically-relevant non-major hemorrhages [ Time Frame: From randomization to End of Study (median 2 years) ]
    Major hemorrhage and clinically relevant non-major as per ISTH criteria

  3. Recurrent ischemic stroke & MRI-detected incident covert brain infarction [ Time Frame: From randomization to End of Study (median 2 years) ]
    Symptomatic investigator reported ischemic stroke and MRI detected covert brain infarct as determined by MRI corelab reading baseline and end of study MRI

  4. Recurrent ischemic stroke [ Time Frame: From randomization to End of Study (median 2 years) ]
    Recurrent ischemic stroke that is restricted to the area of the qualifying stenosis

  5. Composite of stroke, myocardial infarction or vascular death [ Time Frame: From randomization to End of Study (median 2 years) ]
    Composite of stroke, MI or vascular death



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 40 years
  2. Recent brain ischemia attributed to intracranial atherosclerotic stenosis of 30-99% as evidenced by CT or MR angiography, occurring between 7 to 100 days prior to randomization and consisting of either:

    1. a high-risk TIA defined as TIA with motor and/or speech involvement or
    2. an ischemic stroke
  3. Written informed consent consistent with local regulations governing research in human subjects

Exclusion Criteria:

  1. Indication for DAPT for > 90 days on guideline recommendations or investigator ́s judgment; e.g., cardiac stenting.
  2. Indication for chronic anticoagulation based on guideline recommendations or investigator ́s judgment; e.g. patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state
  3. Atrial fibrillation or a history of atrial fibrillation
  4. Intracranial arterial occlusion (e.g. 100% stenosis) responsible for the acute brain ischemia
  5. Intracranial arterial stenosis secondary to causes other than atherosclerosis
  6. Extracranial carotid artery disease ipsilateral to the qualifying brain ischemia with a plan for carotid revascularization
  7. Intraluminal thrombus
  8. Subdural hematoma within 12 months of randomization
  9. Previous spontaneous hemorrhagic stroke (e.g. intracerebral or subarachnoid hemorrhage)
  10. Traumatic brain hemorrhage within 1 month of randomization
  11. Contraindication for MRI scan (e.g. pacemaker incompatible with MRI)
  12. Advanced kidney disease (recent estimated GFR <30 ml per minute)
  13. Modified Rankin Scale (mRS) >=4 at entry
  14. Platelet count less than 100,000/mm3 at enrolment or other bleeding diathesis
  15. Uncontrollable hypertension with systolic BP/ diastolic BP consistently above180/100mmHg after treatment
  16. Known hypersensitivity to either ASA or rivaroxaban
  17. Life expectancy less than 6 months
  18. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e., human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, or posaconazole, if used systemically
  19. Female of childbearing potential who are not surgically sterile, or, if sexually active not willing to use adequate contraceptive measures with a failure rate less than 1% per year (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study, as well as pregnant or breast-feeding women
  20. Inability to adhere to study procedures
  21. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)
  22. Previous randomization to this study or participating in a study with an investigational drug or medical device at the time of randomization
  23. Antiphospholipid antibody syndrome

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): NCT04142125


Contacts
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Contact: Amanda Taylor 905.527.4322 ext 40508 CATIS-ICAD@phri.ca
Contact: Anna Cheng 905.527.4322 ext 41089 CATIS-ICAD@phri.ca

Locations
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Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Rhema Research Institute Recruiting
Owen Sound, Ontario, Canada, N4K 6M9
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
Population Health Research Institute
Investigators
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Principal Investigator: Kanjana S. Perera, MD, FRCPC Hamilton Health Sciences Corporation
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT04142125    
Other Study ID Numbers: CATIS-ICAD
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Population Health Research Institute:
Pilot study
Rivaroxaban
Factor Xa Inhibitors
Intracranial Atherosclerotic Disease
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Aspirin
Rivaroxaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors