EVALUATION OF TWO SECONDARY CARE STRATEGIES AFTER STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA): ACHEIVED TARGET LDL-C TO 100 mg/dL (+/- 10,mg/dL) OR LESS THAN 70 mg/dL.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,873
- 试验地点
- 4
- 主要终点
- recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
研究概览
简要总结
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and vascular death in each group.
3760 patients will be recruited and followed for eight and a half years maximum.
详细描述
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
Inclusion criteria:
- Recent (less than 3 months) ischemic stroke As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment). These ischemic strokes include TIA with ischemic lesion documented by CT or MRI.
- Or recent TIA (less than 15 days) without documentation of ischemic lesion on CT/MR imaging. Must be limb weakness or aphasia lasting more than 10 min.
- And documented atherosclerotic stenosis in carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray- angiography), Or in the aortic arch (investigator judgment) (based on TEE or CTA), Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA), Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography)
- And statin treatment is indicated, following ANSM guidelines (French drug agency), age >18 years, rankin score ≤ 4, patient or a legal representative signs consent, patient is affiliated to social security system
Exclusion criteria :
- Ischemic stroke/TIA du to arterial dissection (investigator judgment)
- Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- Symptomatic hemorrhagic stroke : Presence of microbleeds on gradient echo imaging (T2*) is not an exclusion criteria. Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
- Uncontrolled hypertension (investigator judgment)
- LDL-C <100 mg/dL or patients for whom treatment intensification is impossible
- F/U impossible or bad observance anticipated.
- Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint
- Participation to another clinical trial
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Recent (less than 3 months) ischemic stroke
- •As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment)
- •These ischemic strokes include TIA with ischemic lesion documented by CT or MRI
- •Or recent TIA (less than 15 days)
- •without documentation of ischemic lesion on CT/MR imaging
- •Must be limb weakness or aphasia lasting more than 10 min
- •And documented atherosclerotic stenosis
- •In carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray- angiography)
- •Or in the aortic arch (investigator judgment) (based on TEE or CTA)
- •Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA)
- •Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography)
- •Statin treatment is indicated, following ANSM guidelines (French drug agency)
- •age >18 years
- •rankin score ≤ 4
- •patient or a legal representative signs consent
- •Patient is affiliated to social security system
排除标准
- •• Ischemic stroke/TIA du to
- •arterial dissection (investigator judgment)
- •Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- •Symptomatic hemorrhagic stroke
- •Presence of microbleeds on gradient echo imaging (T2*) is not an exclusion criteria.
- •Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
- •Uncontrolled hypertension (investigator judgment)
- •LDL-C <100 mg/dL or patients for whom treatment intensification is impossible
- •F/U impossible or bad observance anticipated.
- •Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint
- •Participation to another clinical trial
研究组 & 干预措施
LDL-C to100 mg/dL (+/-10 mg/dL)
Target : 100 mg/dL (+/-10 mg/dL):
Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of 100 mg/dL(+/-10 mg/dL).
干预措施: Target : 100 mg/dL (+/-10 mg/dL) (Procedure)
LDL-C < 70 mg/dL
70 mg/dL: Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of less than 70 mg/dL.
干预措施: 70 mg/dL (Procedure)
结局指标
主要结局
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
时间窗: each 6 months
recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.
次要结局
- All causes deaths(each 6 months)
- Recurrent ischemic stroke, fatal or non(each 6 months)
- Recurrent ischemic stroke or TIA(each 6 months)
- Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)(each three weeks until target is not achieved then each 6 months)
- Recurrent nonfatal ischemic stroke(each 6 months)
- Nonfatal myocardial infarction(each 6 months)
- Any revascularisation procedure (coronary, carotid, or peripheral artery))(each 6 months)
- All stroke (ischemic or hemorrhagic)(each three weeks until target is not achieved then each 6 months)
- Any major coronary events (including fatal and nonfatal myocardial infarction)(each 6 months)
- Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)(each 6 months)
- Carotid artery revascularization procedure (urgent following new symptoms or elective)(each 6 months)
- Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)(each 6 months)
- Primary endpoint plus intracranial hemorrhage(each 6 months)
- New onset diabetes(each 6 months)