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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Treatments: Aspirin; Rivaroxaban

Criteria

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