Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 25, 2019
First Posted Date  ICMJE October 29, 2019
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE February 3, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • Recruitment rate [ Time Frame: From randomization to end of recruitment (2 years) ]
    Recruitment rate of potentially eligible patients from neurology clinics
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • Major hemorrhage [ Time Frame: From randomization to End of Study (median 2 years) ]
    Major hemorrhage as defined by ISTH criteria
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease
Official Title  ICMJE Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Ischemic Stroke
  • Intracranial Atherosclerotic Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Experimental (riva + ASA)
    Rivaroxaban 2.5mg bid + aspirin 81mg qd
    Interventions:
    • Drug: Rivaroxaban 2.5 Mg Oral Tablet bid
    • Drug: Acetylsalicyclic acid 81 mg tablet qd
  • Active Comparator: Control (ASA alone)
    Aspirin 81 mg qd
    Intervention: Drug: Acetylsalicyclic acid 81 mg tablet qd
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amanda Taylor 905.527.4322 ext 40508 CATIS-ICAD@phri.ca
Contact: Anna Cheng 905.527.4322 ext 41089 CATIS-ICAD@phri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04142125
Other Study ID Numbers  ICMJE CATIS-ICAD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kanjana S. Perera, MD, FRCPC Hamilton Health Sciences Corporation
PRS Account Population Health Research Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP