NCT03160677已完成不适用
Comparison of Two Strategies for Blood Pressure Control in the Setting of Acute Ischemic Stroke to Reduce Cerebral Hemorrhage After Thrombectomy: Systolic Blood Pressure Target of Less Than 130 mmHg vs Less Than 185 mmHg, for 24 Hours Following Reperfusion, in Patients With Cerebral Infarction Due to Occlusion of the Anterior Circulation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 10
- 主要终点
- Rate of patients with intracranial hemorrhagic complications
研究概览
简要总结
A randomized, multicenter study comparing two strategies: 1 / standard management of systolic blood pressure according to international recommendations (systolic blood pressure <185 mm Hg) versus 2 / intensive blood pressure management Systolic with a target <130 mm Hg.
详细描述
Patients will be followed for 3 months:
- inclusion after reperfusion: clinical evaluation with NIHSS (National Institute of Health Stroke Score) score, measurement of blood pressure.
- within 24 hours after reperfusion: blood pressure measurements
- at 24 hours: measurement of blood pressure (T0 + 24 h and evaluation of the NIHSS score.
- Between 24 and 36 hours :cerebral scan (assessment of hemorrhagic transformations and cerebral infarction volumes). For some centers: Cerebral MRI without injection between H24 and H36
- 72 hours after reperfusion: Cerebral scanner in case of hyperdensity on the initial scanner
- 3 months after reperfusion: disability assessment by Rankin score
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
- Single (Outcomes Assessor)
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
- •Intracranial Occlusion of internal carotid arteries and/or proximal middle cerebral (segment M1) diagnosis made on initial Imaging.
- •Reperfusion after a thrombectomy procedure (defined by a 2b-3 TICI score -Thrombolysis In Cerebral Infarction- score).
排除标准
- •Per-procedure hemorrhagic complications (prior to reperfusion)
- •Systolic blood pressure at baseline <130 mm Hg within one hour of recanalization
- •Pre-existing stroke handicap defined by a Rankin score (modified scale, mRS)> 3
- •Hemodynamically significant carotid stenosis
- •Occlusion of the isolated cervical carotid artery
- •Known pregnancy
- •Legal protection
- •Non-affiliation to a social security scheme
- •Refusal of the patient (or of his / her relatives in case of urgent inclusion)
结局指标
主要结局
Rate of patients with intracranial hemorrhagic complications
时间窗: Scan performed between 24 and 36 hours after thrombectomy
Rate of patients with intracranial hemorrhagic complications (Symptomatic or asymptomatic) on cerebral scan, evaluated with a double centralized blind reading
次要结局
未报告次要终点
研究者
研究点 (10)
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