Colchicine in High-risk Patients With Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3)

Inclusion Criteria:

1. 40 years or older than 40 years；

2. 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)；

3. With a hsCRP level of ≥2mg/L at randomization;

4. Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset isdefined by the "last seen normal" principle)；

5. Informed consent signed.

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 (e.g., numbness), isolated visual changes, orisolated dizziness/vertigo without evidence of acute infarction on baseline head CTor MRI.

3. Iatrogenic causes (angioplasty or surgery) of stroke or TIA.

4. Presumed cardiac source of embolus, such as atrial fibrillation or prostheticcardiac valve).

5. A score of ≥ 2 on the modified Rankin scale immediately before the occurrence of theindex event.

6. Usage of colchicine within 30 days before randomization or planning to takecolchicine therapy for other indications.

7. Known allergy or sensitivity or intolerance to colchicine.

8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea.

9. Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular diseaseor with creatine kinase (CK) level > 3 times the upper limit of normal as measuredwithin the past 30 days and determined to be non-transient through repeat testing.

10. A history of cirrhosis, chronic active hepatitis or severe hepatic disease.

11. Impaired hepatic (ALT or AST > twice the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization.

12. Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) orleucopenia (white blood cell <3×109/L) at randomization.

13. In the acute phase of respiratory tract infection, urinary tract infection, andgastro-enteritis, or currently using or planning to receive oral or intravenousanti-infective therapy for any other infection.

14. Currently using or planning to begin long-term (>7 days) systemic anti-inflammatorydrugs (NSAIDs except for aspirin, oral or intravenous steroid therapy) during thestudy.

15. Planning to use moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin,telithromycin, other macrolide antibiotics, ketoconazole, itraconazole,voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors,verapamil, diltiazem, quinidine, digoxin, disulfiram, etc) or P-gp inhibitors (cyclosporine) at randomization.

16. Planned surgery or interventional treatment requiring cessation of the study drugduring the study.

17. Participating in another clinical trial with an investigational drug or deviceconcurrently or during the last 30 days.

18. Women of childbearing age who were not practicing reliable contraception and did nothave a documented negative pregnancy test or severe noncardiovascular coexistingcondition.

19. Severe non-cardiovascular comorbidity with a life expectancy of less than 3 months.

20. With a history of clinically significant drug or alcohol abuse.

21. Inability to understand and/or follow research procedures due to mental, cognitive,or emotional disorders, or to be an unsuitable candidate for the study for any otherconsidered by the investigator.