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RIISC THETIS Evaluation of low dose colchicine in prevention of ischemic stroke in patients with stroke due to atherosclerosis. Reducing inflammation in ischemic stroke with colchicine (riisc),

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513669-38-00
Acronym
APHP211055
Enrollment
1400
Registered
2024-09-26
Start date
2023-05-17
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic, TIA, Cardiac Disease, Atherosclerosis, Myocardial Infarction, Coronary Syndrome, Cerebral Infarction

Brief summary

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 60 months)

Detailed description

Recurrent fatal and nonfatal ischemic stroke or urgent carotid revascularization following a new transient ischemic attack with negative neuro-imaging during the study, Recurrent fatal and nonfatal ischemic stroke during the study, Fatal and nonfatal myocardial infarction or urgent coronary revascularization following a new acute coronary syndrome during the study, Fatal and nonfatal myocardial infarction during the study, Vascular death during the study, Any stroke during the study, Any stroke or TIA during the study, Major coronary events (including MI) during the study, Any coronary end-points (MI, hospitalization for recurrent ACS, coronary revascularization procedure urgent or elective, fatal coronary event) during the study, Any death during the study, Fatal and non-fatal stroke with mRS>1, All revascularization procedures (coronary, carotid, peripheral) during the study, Carotid revascularization during the study

Interventions

DRUGcomprimé sécable

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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 60 months)

Secondary

MeasureTime frame
Recurrent fatal and nonfatal ischemic stroke or urgent carotid revascularization following a new transient ischemic attack with negative neuro-imaging during the study, Recurrent fatal and nonfatal ischemic stroke during the study, Fatal and nonfatal myocardial infarction or urgent coronary revascularization following a new acute coronary syndrome during the study, Fatal and nonfatal myocardial infarction during the study, Vascular death during the study, Any stroke during the study, Any stroke or TIA during the study, Major coronary events (including MI) during the study, Any coronary end-points (MI, hospitalization for recurrent ACS, coronary revascularization procedure urgent or elective, fatal coronary event) during the study, Any death during the study, Fatal and non-fatal stroke with mRS>1, All revascularization procedures (coronary, carotid, peripheral) during the study, Carotid revascularization during the study

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026