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

NCT ID: NCT07035405

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 7500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-04
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Colchicine Group

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

Group Type: EXPERIMENTAL

Colchicine 0.5 mg

Intervention Type: DRUG

Oral colchicine will be initiated with a dose of 0.5 mg per day.

Placebo Colchicine Group

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

Group Type: PLACEBO_COMPARATOR

Placebo colchicine

Intervention Type: DRUG

Oral placebo colchicine will be initiated with a dose of 0.5 mg per day.

Interventions

Colchicine 0.5 mg

Oral colchicine will be initiated with a dose of 0.5 mg per day.

Intervention Type: DRUG

Placebo colchicine

Oral placebo colchicine will be initiated with a dose of 0.5 mg per day.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Medical Academy of Research and Translation

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongjun Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Central Contacts

Jiejie Li, Ph.D

Role: CONTACT

neverever1983@gmail.com

+86-18210895564

Other Identifiers

CHANCE-3 EX

Identifier Type: -

Identifier Source: org_study_id