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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2023-09-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemic Stroke Intracranial Atherosclerotic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Blinded assessment of endpoint

Study Groups

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Experimental (riva + ASA)

Rivaroxaban 2.5mg bid + aspirin 81mg qd

Group Type EXPERIMENTAL

Rivaroxaban 2.5 Mg Oral Tablet bid

Intervention Type DRUG

Pts will receive rivaroxaban + aspirin

Acetylsalicyclic acid 81 mg tablet qd

Intervention Type DRUG

Pts will receive ASA

Control (ASA alone)

Aspirin 81 mg qd

Group Type ACTIVE_COMPARATOR

Acetylsalicyclic acid 81 mg tablet qd

Intervention Type DRUG

Pts will receive ASA

Interventions

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Rivaroxaban 2.5 Mg Oral Tablet bid

Pts will receive rivaroxaban + aspirin

Intervention Type DRUG

Acetylsalicyclic acid 81 mg tablet qd

Pts will receive ASA

Intervention Type DRUG

Other Intervention Names

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Xarelto Aspirin

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No