Menu
Not yet recruiting NCT07035405

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

Phase III Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colchicine 0.5 mg, Placebo colchicine.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX): a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial

Overview

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.

Interventions

  • Drug Colchicine 0.5 mg
    Oral colchicine will be initiated with a dose of 0.5 mg per day.
  • Drug Placebo colchicine
    Oral placebo colchicine will be initiated with a dose of 0.5 mg per day.

Primary outcome measures

  • First Event of ischemic stroke, myocardial infarction and vascular death [Time frame: From randomization to occurrence of the first event, with a median follow-up time of 24 months]
Secondary outcome measures (5)
  • Ischemic stroke [Time frame: From randomization to event, with a median follow-up time of 24 months.]
  • Myocardial Infarction [Time frame: From randomization to event, with a median follow-up time of 24 months.]
  • Vascular death [Time frame: 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 [Time frame: At 1 year]
  • mRS shift [Time frame: At 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Clinically significant drug or alcohol abuse in the past year
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07035405 · CHANCE-3 EX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗