Colchicine After Stroke Event to Prevent Event Recurrence (CASPER): A randomised trial to evaluate the efficacy of oral Colchicine in high-risk patients with atherosclerosis-associated inflammation post-Stroke

niversity of Sydney0 sites1,500 target enrollmentOctober 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 20, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Presentation with an ischaemic stroke without major disability (MRS less than or equal to 3 \- at time of registration \[4\-52 weeks]) OR clinical TIA with brain imaging evidence of acute infarction and commenced on OMT
•2\.hs\-CRP greater than or equal to 1\.0mg/L (at time of registration) 4 to 52 weeks post\-stroke event
•3\.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments

•1\.Suspected cardio\-embolic stroke/ TIA, that is probably caused by
•a.Identified atrial fibrillation (permanent or paroxysmal),
•b.Other identified cardiac source (intra\-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction \<30%),
•c.Stroke/ TIA caused by dissection, endo\-carditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours after carotid or cardiac surgery,
•2\.Hypercoagulability states,
•3\.Migraines related to the index stroke or TIA/ Migrainous Strokes, or inherited cerebrovascular disorders.
•4\.Any known intolerance to Colchicine
•5\.Pre\-existing Colchicine treatment for greater than 7 days within the last 3 months
•6\.Current active myopathy with creatine kinase (CK) \>3x upper limit of normal.
•7\.Severe liver disease or aminotransferase level \>3 x upper limit of normal, within the last 3 months