Acute non-disabling cerebrovascular events
Conditions
Interventions
Low-dose group:Colchicine 0.5mg orally taken once daily
Middle-dose group:Colchicine 0.5mg orally taken twice daily (day 1-7)
Colchicine 0.5mg orally taken once daily (day 8-14)
Middle-high-dose group:Colchicine 1.0mg orally taken twice daily (day 1)
Colchicine 0.5mg orally taken twice daily (day 2-7)
High-dose group:Colchicine 1.0mg orally taken 3 times a day (day 1)
Sponsors
The Third People's Hospital of Liaocheng
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-80 years; 2. Patients with acute nondisabling ischemic stroke or transient ischemic attack at intermediate to high risk of stroke as defined below: (1) Acute non-disabling ischemic stroke (NIHSS = 4 at the time of randomization); 3. Can be treated with study drug within 24 hours of symptoms onset (Definition of time of onset of symptoms : time of last looking normal); 4. Informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI; 2. Isolated or pure sensory symptoms (such as numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI; 3. mRS score > 2 points before onset; 4. Clear indication for anticoagulation (presumed cardiac source of embolus, such as atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis); 5. Treatment with colchicine in 1 month before randomization or intolerance to colchicine; 6. Severe hepatic or renal insufficiency (ALT value > 2 x ULN or AST value > 2 x ULN; creatinine > 2 x ULN or glomerular filtration rate <= 50 mL/minute); 7. Anticipated requirement for other anti-inflammatory drugs within 14 days; 8. Current use or Anticipated requirement for moderate to strong inhibitors of CYP3A4 (such as clarithromycin, erythromycin, ritonavir, azanavir) or P-glycoprotein (P-gp) inhibitors (such as cyclosporine); 9. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 14 days requiring study drug cessation; 10. History with infectious disease on randomization; 11. History of symptomatic peripheral neuropathy and progressive neuromuscular disease; 12. Severe non-cardiovascular comorbidity with life expectancy < 14 days or failed to follow the study for other reasons; 13. Participation in another clinical study with an experimental product during the last 30 days; 14. Currently receiving an experimental drug or device; 15. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control; 16. Unsuitable for this study in the opinion of the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High sensitivity C-reactive protein;Adverse events within 14 days; | — |
Countries
China
Contacts
Public ContactWang Yongjun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed