Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors. The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,125
colchicine 0.5mg once-daily
matching placebo, lacking active ingredient, once-daily
Efficacy: MACE and Dependency
Treatment with colchicine will reduce the risk for major adverse cardiovascular events (MACE) and dependency
Time frame: through study completion, an average of 36 months
Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates
There will be no clinically-important change in symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates with oral colchicine 0.5mg OD compared with matching placebo
Time frame: through study completion, an average of 36 months
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