Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX)

Capital Medical University

Status and phase: Not yet enrolling; Phase 3

Conditions: Stroke

Treatments: Drug: Colchicine 0.5 mg; Drug: Placebo colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT07035405

CHANCE-3 EX

Details and patient eligibility

About

The role of colchicine in the secondary prevention of ischemic stroke has not been determinded. This multicenter, randomized, double-blind, placebo-controlled, event-driven clinical trial of CHANCE-3 EX was aimed to assess the efficacy and safety of low-dose colchicine versus placebo on reducing the risk of recurrent ischemic stroke, myocardial infarction and vascular death in patients with minor-to-moderate ischemic stroke.

Enrollment: 7,500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. An age of 18-80 years old
2. Minor-to-moderate ischemic stroke (NIHSS<15 at randomization; confirmed by CT or MRI)
3. Within 7-30 days after the most recent qualifying stroke onset
4. Informed consent signed

Exclusion criteria

1. Iatrogenic causes (angioplasty or surgery) of stroke
2. mRS>3 at randomization
3. Known allergy, sensitivity or intolerance to colchicine
4. Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea
5. Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level > 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing
6. A history of cirrhosis, chronic active hepatitis or severe hepatic disease
7. Impaired hepatic (ALT or AST > three times 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
8. Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) or leucopenia (white blood cell count <3×109/L) at randomization
9. Comorbid gout or other indications for colchicine use
10. Active infection at randomization (including respiratory tract infection, urinary tract infection, or gastroenteritis)
11. Requiring chronic immunosuppressant, glucocorticoid, or nonsteroidal anti-inflammatory drugs therapy (except aspirin) during the study
12. Usage of contraindicated medications for colchicine at randomization: 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)
13. Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days
14. Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test
15. Severe non-cardiovascular comorbidity, active malignant tumors or terminal-stage illnesses, with a life expectancy of less than 2 years
16. Clinically significant drug or alcohol abuse in the past year
17. Any other conditions deemed unsuitable for participation in this study or inability to complete study procedures, including but not limited to mental disorders, cognitive or emotional impairments, or physical conditions that may compromise compliance with study protocols and follow-up visits

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,500 participants in 2 patient groups, including a placebo group

Colchicine Group

Experimental group

Description:

Patients in this arm will receive low-dose colchicine in addition to standard medical care

Treatment:

Drug: Colchicine 0.5 mg

Placebo Colchicine Group

Placebo Comparator group

Description:

Patients in this arm will receive placebo colchicine in addition to standard medical care

Treatment:

Drug: Placebo colchicine