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

Phase 3
Not yet recruiting
Conditions
Stroke
Interventions
Registration Number
NCT07035405
Lead Sponsor
Beijing Tiantan Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
7500
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Colchicine GroupColchicine 0.5 mgPatients in this arm will receive low-dose colchicine in addition to standard medical care
Placebo Colchicine GroupPlacebo colchicinePatients in this arm will receive placebo colchicine in addition to standard medical care
Primary Outcome Measures
NameTimeMethod
First Event of ischemic stroke, myocardial infarction and vascular deathFrom randomization to occurrence of the first event, with a median follow-up time of 24 months

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

Secondary Outcome Measures
NameTimeMethod
Ischemic strokeFrom randomization to event, with a median follow-up time of 24 months.

The descriptive statistics are presented as the number of participants having had ischemic stroke.

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

The descriptive statistics are presented as the number of participants having had myocardial infarction.

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

The descriptive statistics are presented as the number of participants having had a vascular death.

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

The descriptive statistics are presented as the number of participants having had mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year.

mRS shiftAt 1 year

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