Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
研究概览
简要总结
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
详细描述
It is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%.
Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60% to 79%, the AHA guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients.
Our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA coupled with optimal medical therapy.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral carotid artery stenosis that was considered to be severe (carotid artery diameter reduction 70%-79% on ultrasound)
- •This stenosis had not caused any stroke, transient cerebral ischaemia, or other relevant neurological symptoms in the past 6 months
- •Both doctor and patient were substantially uncertain whether to choose immediate CEA, or deferral of any CEA until a more definite need for it was thought to have arisen
- •The patient had no known circumstance or condition likely to preclude long-term follow-up
- •Neurologist's explicit consent to potentially perform CEA
排除标准
- •Previous ipsilateral CEA
- •Expectation of poor surgical risk (e.g., because of recent acute myocardial infarction)
- •Some probable cardiac source of emboli (because the main stroke risk might then be from cardiac, not carotid, emboli)
- •Inability to provide informed consent
- •Underlying disease other than atherosclerosis (inflammatory or autoimmune disease)
- •Life expectancy < 6 months
- •Advanced dementia
- •Advanced renal failure (serum creatinine > 2.5 mg/dL)
- •Unstable severe cardiovascular comorbidities (e.g., unstable angina, heart failure)
- •Restenosis after prior CAS or CEA
- •Atrial fibrillation
- •Allergy or contraindications to study medications (statins, ASA, losartan, amlodipine)
研究组 & 干预措施
CEA Group
Patients will undergo carotid endarterectomy (CEA) and receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.
干预措施: Carotid Endarterectomy (Procedure)
CEA Group
Patients will undergo carotid endarterectomy (CEA) and receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.
干预措施: atorvastatin, aspirin, losartan, amlodipine (Drug)
OMT Group
Patients will receive conservative therapy - optimal medical treatment (OMT) including statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.
干预措施: atorvastatin, aspirin, losartan, amlodipine (Drug)
结局指标
主要结局
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
时间窗: 5 years
次要结局
- composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death(5 years)
研究者
Igor Kolos
Senior Researcher
Russian Cardiology Research and Production Center