Evaluation of low dose colchicine and ticagrelor in prevention of ischemic stroke in patients with stroke due to atherosclerosis
Conditions
Interventions
Trade Name: BRILIQUE 90 mg
Product Name: Ticagrelor
Pharmaceutical Form: Tablet
INN or Proposed INN: Ticagrelor
Current Sponsor code: BRILIQUE
Other descriptive name: Ticagrelor
Concentration unit: mg
Sponsors
APHP DRCI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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: a) 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) b) 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) c) or presence of atherosclerotic disease of the aortic arch with a plaque =4mm in thickness with or without superimposed thrombus, or a plaque =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term efficacy of low dose colchicine and of ticagrelor 90 mg b.i.d. on the reduction of a composite primary outcome cluster of recurrent major vascular events ;Secondary Objective: ;Primary end point(s): Composite of: nonfatal ischemic stroke or nonfatal hemorrhagic stroke or undetermined stroke, nonfatal myocardial infarction, urgent coronary or carotid revascularization following new symptoms, and vascular death including sudden death during the study (from 36 to 48 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Recurrent fatal and nonfatal ischemic stroke or urgent carotid revascularization following a new transient ischemic attack with negative neuro-imaging during the study 2. Recurrent fatal and nonfatal ischemic stroke during the study 3. Fatal and nonfatal myocardial infarction or urgent coronary revascularization following a new acute coronary syndrome during the study 4. Fatal and nonfatal myocardial infarction during the study 5. Vascular death during the study 6. Any stroke during the study 7. Any stroke or TIA during the study 8. Major coronary events (including MI) during the study 9. Any coronary end-points (MI, hospitalization for recurrent ACS, coronary revascularization procedure urgent or elective, fatal coronary event) during the study 10. Any death during the study 11. All revascularization procedures (coronary, carotid, peripheral) during the study 12. Carotid revascularization during the study | — |
Countries
France
Outcome results
None listed