Colchicine in High-risk Patients With Acute Minor-to-moderate Ischemic Stroke or Transient Ischem… (NCT05439356) | Clinical Trial Compass
CompletedPhase 3
Colchicine in High-risk Patients With Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3)
China8,343 participantsStarted 2022-08-11
Plain-language summary
This study is a multicentre, randomized, double-blind, placebo-controlled, investigator-sponsored study that aims to investigate the efficacy of colchicine in preventing recurrent stroke in the patients with acute minor-to-moderate ischemic stroke or TIA and a hsCRP level of ≥2mg/L.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. 40 years or older than 40 years；
✓. Acute cerebral ischemic event due to： Acute minor-to-moderate ischemic stroke (NIHSS≤5 at the time of randomization) or TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 4 at the time of randomization)；
✓. With a hsCRP level of ≥2mg/L at randomization;
✓. Can be treated with study drug within 24 hours of symptoms onset\*(\*Symptom onset is defined by the "last seen normal" principle)；
✓. Informed consent signed.
Exclusion criteria
✕. Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
✕. Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
✕. Iatrogenic causes (angioplasty or surgery) of stroke or TIA.
✕. Presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve).
✕. A score of ≥ 2 on the modified Rankin scale immediately before the occurrence of the index event.
✕. Usage of colchicine within 30 days before randomization or planning to take colchicine therapy for other indications.