Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients Wit… (NCT05476991) | Clinical Trial Compass
RecruitingPhase 3
Evaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis
France2,800 participantsStarted 2023-05-17
Plain-language summary
REDUCING INFLAMMATION IN ISCHEMIC STROKE WITH COLCHICINE, AND TICAGRELOR IN HIGH-RISK PATIENTS-EXTENDED TREATMENT IN ISCHEMIC STROKE.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. 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
✓. and documented atherosclerotic stenosis:
✓. 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)
✓. 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)
✓. 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)
✓
What they're measuring
1
Number of Participants with nonfatal ischemic stroke
Timeframe: 36 months
2
Number of Participants with undetermined stroke
Timeframe: 36 months
3
Number of Participants with nonfatal myocardial infarction
Timeframe: 36 months
4
Number of Participants with urgent coronary or carotid revascularization following new symptoms
Timeframe: 36 months
5
Number of Participants with vascular death including sudden death
. 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)
✕. Hypersensitivity to ticagrelor or any of the excipients.
✕. Hypersensitivity to colchicine or any of the excipients.
✕. Major digestive disorders (chronic diarrhea, inflammatory disease of the digestive tract as uncontrolled ulcerative colitis or active Crohn disease)
✕. Immunosuppression, medullary aplasia
✕. Active chronic inflammatory disease, chronic active infection, evolving cancer
✕. Hemodynamic instability (need for amines for more than 24 hours, circulatory assistance)
✕. A recent severe sepsis (7 days) or all recent acute reaches