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

NCT07035405 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CHANCE-3 EX
• Study Type: interventional
• Target: 7,500
• Locations: 0 countries
• Sites: N/A

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

Keywords

stroke; colchicine; secondary prevention

Outcome Measures

Primary Outcomes (1)

• First Event of ischemic stroke, myocardial infarction and vascular death

  The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.

  From randomization to occurrence of the first event, with a median follow-up time of 24 months

Secondary Outcomes (5)

• Ischemic stroke

  From randomization to event, with a median follow-up time of 24 months.

• Myocardial Infarction

  From randomization to event, with a median follow-up time of 24 months.

• Vascular death

  From randomization to death, with a median follow-up time of 24 months.

• mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year

  At 1 year

• mRS shift

  At 1 year

Other Outcomes (2)

• Any serious adverse event

  Through study completion, a median follow-up time of 24 months.

• Adverse events of special interest

  Through study completion, a median follow-up time of 24 months.

Study Arms (2)

Colchicine Group

EXPERIMENTAL

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

Drug: Colchicine 0.5 mg

Placebo Colchicine Group

PLACEBO COMPARATOR

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

Drug: Placebo colchicine

Interventions

Colchicine 0.5 mg DRUG

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

Colchicine Group

Placebo colchicine DRUG

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

Placebo Colchicine Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Iatrogenic causes (angioplasty or surgery) of stroke
• mRS\>3 at randomization
• Known allergy, sensitivity or intolerance to colchicine
• Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea
• 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
• A history of cirrhosis, chronic active hepatitis or severe hepatic disease
• 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
• Anemia (haemoglobin \<10g/dL), thrombocytopenia (platelet count \<100×109/L) or leucopenia (white blood cell count \<3×109/L) at randomization
• Comorbid gout or other indications for colchicine use
• Active infection at randomization (including respiratory tract infection, urinary tract infection, or gastroenteritis)
• Requiring chronic immunosuppressant, glucocorticoid, or nonsteroidal anti-inflammatory drugs therapy (except aspirin) during the study
• 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)
• Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days
• Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test
• Severe non-cardiovascular comorbidity, active malignant tumors or terminal-stage illnesses, with a life expectancy of less than 2 years

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Shenzhen Medical Academy of Research and Translation: collaborator

MeSH Terms

Conditions

Stroke

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Yongjun Wang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiejie Li, Ph.D

CONTACT

+86-18210895564; neverever1983@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 25, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share