Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 13
- 主要终点
- Hierarchical composite endpoint (HCE) that combines MACE and dependency, which includes the following components:
研究概览
简要总结
To demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with documented spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset (or last seen normal)
- •Qualifying for at least one of the following categories: i. history of symptomatic coronary, peripheral and/or carotid artery disease (symptomatic atherosclerotic disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease that protrudes into the vessel lumen (imaging confirmation of atherosclerotic disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (eGFR: 15-50mL/min), history of ischemic stroke or current smoking (risk for atherosclerotic disease)
- •Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
排除标准
- •Secondary causes of ICH (relating to trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
- •ICH volume more than 40 ml on the most recent imaging scan obtained prior to consent
- •ICH score 3 or higher
- •Glasgow Coma Scale (GCS) score equal to or <8 at the time of consent or on mechanical ventilation
- •Inflammatory bowel disease or chronic diarrhea
- •Cirrhosis or severe hepatic dysfunction
- •Renal insufficiency (eGFR <15mL/min)
研究组 & 干预措施
Placebo 0.5mg tablet
干预措施: Placebo 0.5mg tablet (Drug)
Colchicine Aspire 0.5 mg Tablets
干预措施: Colchicine Aspire 0.5 mg Tablets (Drug)
结局指标
主要结局
Hierarchical composite endpoint (HCE) that combines MACE and dependency, which includes the following components:
Hierarchical composite endpoint (HCE) that combines MACE and dependency, which includes the following components:
a. time-to first stroke (ischemic, hemorrhagic or undefined)
a. time-to first stroke (ischemic, hemorrhagic or undefined)
b. time-to cardiovascular death
b. time-to cardiovascular death
c. dependency, defined as modified Rankin Scale scores (mRS) between 3 and 5, at 6 months from randomization
c. dependency, defined as modified Rankin Scale scores (mRS) between 3 and 5, at 6 months from randomization
d. time-to first myocardial infarction
d. time-to first myocardial infarction
e. time-to first revascularization procedure for coronary, carotid, or peripheral arterial disease
e. time-to first revascularization procedure for coronary, carotid, or peripheral arterial disease
次要结局
- Functional outcome at 6-months, assessed with the modified Rankin Score (mRS) scale
- Cognitive outcome at the end of study, assessed by the telephone Montreal Cognitive Assessment (T-MoCA) and the telephone Mental Alternation Test (t-MAT)
- Quality of life at the end of study, assessed with the EQ-5D-5L [global questionnaire]
- Disabling or fatal stroke during follow-ups, assessed with the Modified Rankin Scale (mRS) scale
研究者
Aris Katsanos
Scientific
Hamilton Health Sciences Corporation