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

September 24, 2023 updated by: Population Health Research Institute

Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Alberta Health services
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute
      • Owen Sound, Ontario, Canada, N4K 6M9
        • Rhema Research Institute
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Science Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Xarelto
Drug: Acetylsalicyclic acid 81 mg tablet qd
Pts will receive ASA
Other Names:
  • Aspirin
Active Comparator: Control (ASA alone)
Aspirin 81 mg qd
Drug: Acetylsalicyclic acid 81 mg tablet qd
Pts will receive ASA
Other Names:
  • Aspirin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: From randomization to end of recruitment (2 years)
Recruitment rate of potentially eligible patients from neurology clinics
From randomization to end of recruitment (2 years)
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
From randomization to end of recruitment (2 years)
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
From randomization to End of Study (median 2 years)
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
From randomization to End of Study (median 2 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major hemorrhage
Time Frame: From randomization to End of Study (median 2 years)
Major hemorrhage as defined by ISTH criteria
From randomization to End of Study (median 2 years)
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
From randomization to End of Study (median 2 years)
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
From randomization to End of Study (median 2 years)
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
From randomization to End of Study (median 2 years)
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
From randomization to End of Study (median 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kanjana S. Perera, MD, FRCPC, Hamilton Health Sciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CATIS-ICAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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