REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.
Our main hypothesis is that low-dose colchicine (0.5 mg/day) on top of best medical care, in patients with an ischemic stroke with ipsilateral atherosclerotic stenosis, will reduce the risk of major vascular events after 36-60 months of treatment as compared to no colchicine. Our second main hypothesis, tested in 2x2 factorial design, is that ticagrelor 90 mg bid in the same patients, will reduce the long-term risk of major vascular events (after 36-60 months of treatment) as compared to aspirin 75-300 mg/day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,800
Colchicine is a medication used to treat gout and Behçet's disease. In gout, it is less preferred to NSAIDs or steroids. Other uses for colchicine include the management of pericarditis and familial Mediterranean fever.
Ticagrelor, sold under the brand name Brilinta among others, is a medication used for the prevention of stroke, heart attack and other events in people with acute coronary syndrome, meaning problems with blood supply in the coronary arteries. It acts as a platelet aggregation inhibitor by antagonising the P2Y 12 receptor.
Also known as Aspirin, acetylsalicylic acid (ASA) is a commonly used drug for the treatment of pain and fever due to various causes. Acetylsalicylic acid has both anti-inflammatory and antipyretic effects. This drug also inhibits platelet aggregation and is used in the prevention of blood clots stroke, and myocardial infarction (MI).
URC Lariboisière-Fernand Widal-Saint Louis
Paris, Paris, France
RECRUITINGNumber of Participants with nonfatal ischemic stroke
Sudden onset of focal neurologic symptoms related to impaired cerebral circulation. ASCOD phenotyping will be used. TIAs will not be part of strokes. However, any focal neurologic symptoms associated with positive DWI or hypodensity on the CT scan in an appropriate area in relation with these symptoms will be considered a cerebral infarction and be part of "strokes".
Time frame: 36 months
Number of Participants with undetermined stroke
Sudden onset of focal neurologic symptoms related to impaired cerebral circulation. ASCOD phenotyping will be used. TIAs will not be part of strokes. However, any focal neurologic symptoms associated with positive DWI or hypodensity on the CT scan in an appropriate area in relation with these symptoms will be considered a cerebral infarction and be part of "strokes".
Time frame: 36 months
Number of Participants with nonfatal myocardial infarction
* Fatal or nonfatal myocardial infarction (OMS.AHA/ACC definition) o Clinical symptoms + elevated troponin * Silent myocardial infarction following universal definition
Time frame: 36 months
Number of Participants with urgent coronary or carotid revascularization following new symptoms
Revascularization Procedure * Coronary : Angioplasty or stenting or CABG * Carotid : angioplasty or stenting, surgical endarterectomy * Peripheral: angioplasty or stenting including aorta, surgical by-pass or endarterectomy of a peripheral artery.
Time frame: 36 months
Number of Participants with vascular death including sudden death
\- Vascular death * Death due to cardiac or vascular cause * Death due to systemic hemorrhage * Death due to pulmonary embolism * Sudden death: death occurring within 24 hours, unexpected in a patient in apparent healthy condition or condition that was stable or improved * Death without documented nonvascular cause * Fatal stroke: death occurring within 30 days of stroke onset (whether ischemic or hemorrhagic).
Time frame: 36 months
Number of Participants with recurrent fatal and nonfatal ischemic stroke
Time frame: 36 months
Number of Participants with urgent carotid revascularization following a new transient ischemic attack with negative neuro-imaging
Time frame: 36 months
Number of Participants with fatal and nonfatal myocardial infarction
Time frame: 36 months
Number of Participants with fatal and nonfatal myocardial infarction or urgent coronary revascularization following a new acute coronary syndrome
Time frame: 36 months
Number of Participants with vascular death
Time frame: 36 months
Number of Participants with any stroke or TIA
A TIA is defined by sudden onset of neurologic symptoms presumed of ischemic origin, with total resolution, being clearly related to focal cerebral or retinal involvement, and with negative neuro-imaging in the cerebral area corresponding to the symptoms. TIA diagnosis must be confirmed by a neurologist, based on clinical and negative neuro-imaging evaluation (MRI with DWI is recommended).
Time frame: 36 months
Number of Participants with major coronary events
Time frame: 36 months
Number of Participants with any coronary end-points (MI, hospitalization for recurrent ACS, coronary revascularization procedure urgent or elective, fatal coronary event)
ACS: Acute Coronary Syndrome
Time frame: 36 months
Number of death participant (any death)
Time frame: 36 months
Number of Participant with all revascularization procedures (coronary, carotid, peripheral)
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Time frame: 36 months
Number of Participants with Carotid revascularization
Time frame: 36 months