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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• First Event of ischemic stroke, myocardial infarction and vascular death [Срок оценки: From randomization to occurrence of the first event, with a median follow-up time of 24 months]

Вторичные конечные точки (5)

• Ischemic stroke [Срок оценки: From randomization to event, with a median follow-up time of 24 months.]
• Myocardial Infarction [Срок оценки: From randomization to event, with a median follow-up time of 24 months.]
• Vascular death [Срок оценки: 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 [Срок оценки: At 1 year]
• mRS shift [Срок оценки: At 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07035405 · CHANCE-3 EX

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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