Two-center, Prospective, Randomized, Open-label, Controlled Clinical Trial With Endpoint Evaluation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Any new stroke events
研究概览
简要总结
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization.
详细描述
This study is two-center, prospective, randomized, open-label, controlled, investigator-sponsored study that aims to investigate the efficacy of low-dose colchicine in preventing recurrent stroke in the patients with acute atherothrombotic minor-to-moderate ischemic stroke during hospitalization. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. Patients in one arm will receive colchicine initiated with a dose of 0.5 mg per day during on days 1 through 14. Study visits will be performed on the day of randomization and at discharge. The outcomes were stroke, neurological deterioration, сombined endpoint events (stroke, myocardial infarction and death), bleeding during 14 days of follow-up in an intention-to treat analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form by patient prior to any study-specific procedure.
- •Patient age over 18 years
- •Presence of ipsilateral lesion of the extracranial artery ≥50% according to the European measurement method ECST or its occlusion, as well as stenosis < 50% with signs of morphological instability of the atherosclerotic plaque (ulceration, hemorrhage into the plaque, intimal flotation, mural thrombus, etc.).
- •Minor neurological deficit (NIHSS score ≤5).
- •The duration of development of stroke symptoms before colchicine taken is no more than 48 hours.
- •Confirmation of the presence of a focus of acute ischemia in the brain according to computed tomography or magnetic resonance imaging of the brain.
排除标准
- •The presence of risk factors and conditions that determine a different pathogenetic subtype of ischemic stroke (atrial fibrillation/flutter, ventricular aneurysm, ets.).
- •Hemorrhagic stroke
- •NIHSS score ≤
- •Hospitalization of the patient more than 48 hours from the onset of the disease.
- •Severe anemia, thrombocytopenia, leukopenia.
- •Course of an infectious/viral disease.
- •Concomitant treatment with moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil or pilitin disulfazole) inhibitors (cyclosporine) at randomization.
- •Concomitant severe degenerative disease of the nervous system.
- •Concomitant inflammatory or autoimmune disease.
- •Dementia, established mental illness.
- •History of malignancy, known hepatitis B or C, or HIV infection.
- •Swallowing impairment interfering with oral administration of the study drug.
- •Pregnancy or breastfeeding. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
- •Participation in another clinical study with an investigational product at any time during the 30 days prior to randomization
- •Previous enrolment or randomization in the present study.
- •Decrease renal function with creatinine clearance < 30 ml/min.
- •Presence of contraindications to taking colchicine, acetylsalicylic acid and clopidogrel.
研究组 & 干预措施
Clopidogrel treatment group
All patients in this arm will receive standard treatment including clopidogrel.
干预措施: Clopidogrel (Drug)
Colchicine Group
All patients in this arm will receive colchicine for 14 days in addition to standard medical care without clopidogrel (acetylsalicylic acid, lipid-lowering, antihypertensive, gastroprotective, hypoglycemic drugs if necessary, lifestyle recommendations, early rehabilitation activities).
干预措施: Colchicine (Drug)
结局指标
主要结局
Any new stroke events
时间窗: any time within 14 days
Incidence of any new ischemic stroke.
Neurological deterioration
时间窗: any time within 14 days
Neurological deterioration, defined as an increase in The National Institutes of Health Stroke Scale (NIHSS) of 2 or more. The NIHSS provides a quantitative measure of stroke-related neurologic deficit. The higher the score, the more severe the neurological deficit.
次要结局
- New vascular events(any time within 14 days)
- Bleeding event(any time within 14 days)
- Positive functional outcome(any time within 14 days)
研究者
Mikhail Zykov
Principal Investigator
Research Institute for Complex Problems of Cardiovascular Diseases, Russia