Combination Antithrombotic Treatment for Prevention of Recurrent Ischemic Stroke in IntraCranial Atherosclerotic diseaSe (CATIS- ICAS)

NCT07468448 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CATIS-ICAS
• Study Type: interventional
• Target: 1,172
• Locations: 0 countries
• Sites: N/A

Brief Summary

CATIS-ICAS is a double-blind, randomized, placebo-controlled (RCT), phase III study seeking to demonstrate that oral rivaroxaban 2.5 mg twice daily plus aspirin daily is superior to clopidogrel 75 mg daily plus aspirin daily for 90 days followed by placebo plus aspirin daily for preventing recurrent stroke in those with ischemic stroke secondary to intracranial atherosclerotic disease (ICAD) of 30-99%, when started within 30 days of index stroke.

Conditions

Ischemic Stroke; Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Time to first symptomatic stroke for participants

  Time to first symptomatic stroke (including ischemic, hemorrhagic and undefined) for all participants affected, by treatment arm

  From randomization until end of study visit (12 months after Last Patient First Visit)

Study Arms (2)

Dual pathway inhibition

EXPERIMENTAL

rivaroxaban 2.5mg BID, plus clinical ASA

Drug: Rivaroxaban

Antiplatelet therapy

ACTIVE COMPARATOR

Placebo BID, plus clinical ASA

Drug: ASA

Interventions

Rivaroxaban DRUG

Low-dose rivaroxaban (2.5 mg BID) plus clinical ASA

Dual pathway inhibition

ASA DRUG

clopidogrel loading dose (if applicable), then dual antiplatelet therapy (placebo plus clopidogrel plus clinical ASA) for first 90 days, followed by placebo plus clinical ASA for remainder of treatment period.

Antiplatelet therapy

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
• Ischemic stroke or high-risk TIA (motor and/ or speech involvement)
• Randomization within 30 days of index stroke
• Stroke potentially attributable to ICAS 30-99% (or flow gap on time-offlight MRA) of a major intracranial artery (internal carotid artery, middle cerebral artery, anterior cerebral artery, posterior cerebral artery, intracranial vertebral artery, or basilar artery) by MRA or CTA or catheter angiography.
• Modified Rankin Scale Score \< 4 at randomization
• Ability to obtain informed consent prior to randomization.

You may not qualify if:

• Cardioembolic stroke
• Indication for long-term dual antiplatelet or anticoagulant therapy (e.g. venous thromboembolism, coronary stent, mechanical prosthetic valve)
• Intracranial arterial stenosis secondary to causes other than atherosclerosis e.g. dissection, moya moya disease
• Substantial extracranial carotid artery disease ipsilateral to the qualifying stroke with plans for carotid revascularization
• Intended intracranial stenting for the qualifying stroke
• Symptomatic hemorrhagic transformation of the index stroke, or neuroradiological class 2 (PH2 type) or symptomatic class 3 on Heidelberg scale prior to randomization
• Previous non-traumatic intracerebral hemorrhage, non-aneurysmal subarachnoid hemorrhage (treated aneurysmal subarachnoid hemorrhage will be allowed)
• Subdural hematoma within 12 months prior to randomization or traumatic brain hemorrhage within 1 month prior to randomization
• Advanced kidney disease at randomization (eGFR \<15 ml per minute)
• Platelet count less than 100,000/mm3 at enrolment or other bleeding diatheses
• Uncontrolled hypertension with BP consistently above 180 mmHg for systolic and 110mmHg for diastolic while on treatment
• Known hypersensitivity or contraindication to ASA, clopidogrel or rivaroxaban
• Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) or P- glycoprotein (P-gp)
• Females of childbearing potential who are not surgically sterile, pregnant, or breast-feeding
• Previous randomization to this study

Sponsors & Collaborators

• Population Health Research Institute: lead

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kanjana Perera, MD

  Population Health Research Institute, Hamilton Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin W Reeh, MSc

CONTACT

905-521-2100; CATIS-ICAS@phri.ca

Amanda Taylor, BSc

CONTACT

CATIS-ICAS@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled trial (RCT)

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03