EVALUATION OF LOW DOSE COLCHICINE AND TICAGRELOR IN PREVENTION OF ISCHEMIC STROKE IN PATIENTS WITH STROKE DUE TO ATHEROSCLEROSIS

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.

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

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Aspirin; Colchicine; Ticagrelor

Criteria

Inclusion criteria:

Patient with:

1. cerebral infarction (CI) proven by neuro-imaging (MRI or head-CT), immediately once the neurologic deficit is stabilized (investigator judgement) if the patient was on antiplatelet agent monotherapy after the qualifying event, or after 21 days if the patient was on clopidogrel plus aspirin after the qualifying event, or after 21 to 30 days if the patient was on ticagrelor plus aspirin after the qualifying event (TIA with documented ischemic lesion (MRI or CT) in the appropriate area corresponding to the symptoms will be considered CI, following the current definition)

2. and documented atherosclerotic stenosis:

1. presence of carotid atherosclerotic stenosis (on the basis of carotid duplex, CTA, MRA, XRA - only the report will be required to document atherosclerotic disease) ipsilateral to the cerebral ischemic symptoms (stenosis defined by luminal narrowing ≥30%, judgement of the investigator)

2. or presence of atherosclerotic stenosis of another cerebral artery (documented vertebral artery stenosis, basilar artery stenosis, other intracranial artery stenosis) ipsilateral to the ischemic area (stenosis defined by luminal narrowing ≥30%, judgement of the investigator)

3. or presence of atherosclerotic disease of the aortic arch with a plaque ≥4mm in thickness with or without superimposed thrombus, or a plaque <4 mm with a superimposed mobile thrombus (detected by transesophageal echocardiography or CT angiography)

3. with no clear indication of colchicine treatment (gout, Mediterranean fever) and with an indication to long-term antiplatelet therapy (no clear indication to oral anticoagulant)

4. age equal or above 18

5. Rankin score less than ≤4 (ranges from 0 to 6, with 0 indicating no symptoms, 1 no disability, 2 to 3 needing some help with daily activities, 4 to 5 dependent or bedridden, and 6 death),

6. fully informed and signed inform consent

7. with social security number.

8. medical examination before the participation to the research

9. Under contraception in case of childbearing potential (highly effective: 1) combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation et 2) progestogen-only).

Exclusion Criteria:

1. Colchicine treatment needed (e.g., gout)

2. Hypersensitivity to ticagrelor or any of the excipients.

3. Anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or CYP3A4 substrates than cannot be stopped for the course of this study

4. CI/TIA due to arterial dissection (as documented following the judgment of the investigator) or due to cardiac source of embolism without documented atherosclerotic disease (e.g., mitral stenosis or endomyocardial fibrosis, endocarditis) a patient with a history of myocardial infarction, or with calcified aortic stenosis will be eligible if the above inclusion criteria are also met]

5. Oral anticoagulant indicated (e.g., atrial fibrillation)

6. Symptomatic hemorrhagic stroke (the mere presence of asymptomatic cerebral microbleeding -or hemosiderin deposit - on gradient echo imaging is not an exclusion criteria)

7. Active pathological bleeding.

8. Uncontrolled hypertension (investigator judgement)

9. Follow-up visit impossible or anticipated bad compliance.

10. Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits (e.g., severe hepatic failure, severe renal impairment, cancer).

11. Anticipated pregnancy at time of enrollment in the study

12. Participation to another clinical trial

13. Leukopenia <3000/μl

14. Patients with severe renal impairment (creatinine clearance < 30 ml/min)

15. Patients with severe hepatic impairment

16. Prohibited treatments: All treatments contraindicated during the use of colchicine and/or ticagrelor