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

NCT04142125 | Completed Phase 3 DMC

• 1 other identifier: CATIS-ICAD
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 10

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.

Conditions

Ischemic Stroke; Intracranial Atherosclerotic Disease

Keywords

Pilot study; Rivaroxaban; Factor Xa Inhibitors; Intracranial Atherosclerotic Disease

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Recruitment rate of potentially eligible patients from neurology clinics

  From randomization to end of recruitment (2 years)

• Refusal rate

  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

  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

  Rate of patients who experience an intracranial hemorrhage during the study

  From randomization to End of Study (median 2 years)

Secondary Outcomes (5)

• Major hemorrhage

  From randomization to End of Study (median 2 years)

• Combination of ISTH major hemorrhages & clinically-relevant non-major hemorrhages

  From randomization to End of Study (median 2 years)

• Recurrent ischemic stroke & MRI-detected incident covert brain infarction

  From randomization to End of Study (median 2 years)

• Recurrent ischemic stroke

  From randomization to End of Study (median 2 years)

• Composite of stroke, myocardial infarction or vascular death

  From randomization to End of Study (median 2 years)

Study Arms (2)

Experimental (riva + ASA)

EXPERIMENTAL

Rivaroxaban 2.5mg bid + aspirin 81mg qd

Drug: Rivaroxaban 2.5 Mg Oral Tablet bid; Drug: Acetylsalicyclic acid 81 mg tablet qd

Control (ASA alone)

ACTIVE COMPARATOR

Aspirin 81 mg qd

Drug: Acetylsalicyclic acid 81 mg tablet qd

Interventions

Rivaroxaban 2.5 Mg Oral Tablet bid DRUG

Pts will receive rivaroxaban + aspirin

Also known as: Xarelto

Experimental (riva + ASA)

Acetylsalicyclic acid 81 mg tablet qd DRUG

Pts will receive ASA

Also known as: Aspirin

Control (ASA alone); Experimental (riva + ASA)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• 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:
• a high-risk TIA defined as TIA with motor and/or speech involvement or
• an ischemic stroke
• Written informed consent consistent with local regulations governing research in human subjects

You may not qualify if:

• Indication for DAPT for \> 90 days on guideline recommendations or investigator ́s judgment; e.g., cardiac stenting.
• Indication for chronic anticoagulation based on guideline recommendations or investigator ́s judgment; e.g. patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state
• Atrial fibrillation or a history of atrial fibrillation
• Intracranial arterial occlusion (e.g. 100% stenosis) responsible for the acute brain ischemia
• Intracranial arterial stenosis secondary to causes other than atherosclerosis
• Extracranial carotid artery disease ipsilateral to the qualifying brain ischemia with a plan for carotid revascularization
• Intraluminal thrombus
• Subdural hematoma within 12 months of randomization
• Previous spontaneous hemorrhagic stroke (e.g. intracerebral or subarachnoid hemorrhage)
• Traumatic brain hemorrhage within 1 month of randomization
• Contraindication for MRI scan (e.g. pacemaker incompatible with MRI)
• Advanced kidney disease (recent estimated GFR \<30 ml per minute)
• Modified Rankin Scale (mRS) \>=4 at entry
• Platelet count less than 100,000/mm3 at enrolment or other bleeding diathesis
• Uncontrollable hypertension with systolic BP/ diastolic BP consistently above180/100mmHg after treatment

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (10)

Alberta Health Services

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Rhema Research Institute

Owen Sound, Ontario, N4K 6M9, Canada

Location

Sunnybrook Health Science Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• Perera KS, Sharma MA, Eikelboom JW, Ng KKH, Field TS, Buck BH, Hill MD, Stotts G, Casaubon LK, Mandzia J, Katsanos AH, Yip S, Shoamanesh A, Young GB, Appireddy R, Nayar S, Swartz R, Taylor A, Carrier A, Srivastava A, Deshmukh AS, Zhao R, Hart RG; CATIS-ICAD Investigators. Combination Antithrombotic Therapy for Reduction of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease. Stroke. 2025 Feb;56(2):380-389. doi: 10.1161/STROKEAHA.124.047715. Epub 2025 Jan 9.

  PMID: 39781748 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kanjana S. Perera, MD, FRCPC

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment of endpoint
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: investigator-initiated, open-label, blinded endpoint assessment, controlled, randomized pilot trial (PROBE design)

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: February 3, 2020
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)