A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,125
- 主要终点
- Efficacy: MACE and Dependency
研究概览
简要总结
Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors.
The objective of CoVasc-ICH 2 is 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- •Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:
- •i. history of symptomatic coronary, peripheral and/or carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease causing any degree of stenosis/occlusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular 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 (mild atherosclerotic vascular disease).
排除标准
- •secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
- •ICH volume more than 60ml in the last imaging scan prior to consent
- •Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
- •inflammatory bowel disease or chronic diarrhea
- •cirrhosis or severe hepatic dysfunction
- •renal insufficiency (eGFR<15mL/min)
- •concurrent or planned treatment with strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-gp inhibitors (cyclosporine, ranolazine)
- •pregnancy or breast-feeding
- •known allergy or sensitivity to colchicine
- •a strong indication for colchicine where assignment to placebo is deemed unacceptable
- •estimated life expectancy less than 6 months at the time of enrollment, and
- •inability to adhere to study procedures
研究组 & 干预措施
colchicine 0.5mg OD
干预措施: Colchicine 0.5 MG (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy: MACE and Dependency
时间窗: through study completion, an average of 36 months
Treatment with colchicine will reduce the risk for major adverse cardiovascular events (MACE) and dependency
Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates
时间窗: through study completion, an average of 36 months
There will be no clinically-important change in symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates with oral colchicine 0.5mg OD compared with matching placebo
次要结局
未报告次要终点