Informations générales (source: ClinicalTrials.gov)
Reducing Inflammation in Ischemic Stroke With Colchicine, and Ticagrelor in High-risk Patients-extended Treatment in Ischemic Stroke
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2023
septembre 2027
29 août 2025
REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK
PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.
Etablissements
Critères
Tous
Inclusion criteria:
Patient should have the following:
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. Or TIA lasting more 10 minutes or more (with motor symptoms or aphasia/dysarthria or
visual defect), with total resolution and no brain lesion on neuro-imaging (TIA) and
with ipsilateral carotid stenosis that was revascularized (endarterectomy or
stenting) or with ipsilateral, potentially causal intracranial stenosis ≥70%) 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
3. 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)
4. 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)
5. age equal or above 18
6. 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),
7. fully informed and signed inform consent
8. with social security number.
9. medical examination before the participation to the research
10. 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).
11. Pregnancy test for women of childbearing potential
Patient should have the following:
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. Or TIA lasting more 10 minutes or more (with motor symptoms or aphasia/dysarthria or
visual defect), with total resolution and no brain lesion on neuro-imaging (TIA) and
with ipsilateral carotid stenosis that was revascularized (endarterectomy or
stenting) or with ipsilateral, potentially causal intracranial stenosis ≥70%) 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
3. 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)
4. 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)
5. age equal or above 18
6. 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),
7. fully informed and signed inform consent
8. with social security number.
9. medical examination before the participation to the research
10. 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).
11. Pregnancy test for women of childbearing potential
1. Colchicine treatment needed (e.g., gout, Mediterranean fever)
2. Hypersensitivity to ticagrelor or any of the excipients.
3. Hypersensitivity to colchicine or any of the excipients.
4. Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive
tract as uncontrolled ulcerative colitis or active Crohn disease)
5. Immunosuppression, medullary aplasia
6. Active chronic inflammatory disease, chronic active infection, evolving cancer
7. Hemodynamic instability (need for amines for more than 24 hours, circulatory
assistance)
8. A recent severe sepsis (7 days) or all recent acute reaches
9. Chronic treatment (for more than 6 months) with corticosteroids or NSAIDs (or
repeated high-dose intake for less than 7 days).
10. Anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or
CYP3A4 substrates than cannot be stopped for the course of the course of this study
11. 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 atrial fibrillation, or with a history of myocardial
infarction, or with calcified aortic stenosis will be eligible if the above
inclusion criteria are also met]
12. Indication to long-term oral anticoagulant treatment (e.g., atrial fibrillation)
13. Symptomatic hemorrhagic stroke (the mere presence of asymptomatic cerebral
hemosiderin deposits -so called "microbleedings" - on gradient echo imaging is not
an exclusion criteria)
14. Active pathological bleeding
15. Uncontrolled hypertension (investigator judgement)
16. Follow-up visit impossible or anticipated bad compliance.
17. Intercurrent disease that may interfere with evaluation of the primary end-point or
that may prevent follow-up study visits..
18. Anticipated pregnancy at time of enrollment in the study
19. Breastfeeding woman
20. Patients participating in another pharmaco therapeutic program with an experimental
therapy that is known to affect the ticagrerlor, colchicine or aspirine therapy.
21. Leukopenia <3000/μl
22. Patients with severe renal impairment (creatinine clearance < 30 ml/min)
23. Patients with severe hepatic impairment
24. Prohibited treatments: All treatments contraindicated during the use of colchicine
and/or ticagrelor