Clevidipine Infusion for Blood Pressure Management After Successful Revascularization in Acute Ischemic Stroke (CLEVER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint (Drug-related)
研究概览
简要总结
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset.
详细描述
The CLEVER Study is a prospective, 2-arm, randomized, single-center pilot study to assess the safety and efficacy of intensive blood pressure control using Clevidipine (on-label use) in AIS patients undergoing standard of care mechanical thrombectomy (MT) within 24-hours of symptoms onset. Eligible patients will be randomized 1:1 to a systolic blood pressure goal after successful MT (mTICI 2c or greater) of either: 90-120mmHg (Intensive BP management group) or 90-160mmHg (Standard BP management group). Patients enrolled into the study will be followed and assessed for up to 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age 18 or older
- •Acute hypertension (systolic blood pressure of greater than 140 mmHg) at recanalization
- •Anterior circulation ischemic stroke symptoms and confirmed occlusion (ICA, M1, or M2) on angiogram with mechanical thrombectomy initiated within 24 hours since last known well
- •Success revascularization score of mTICI 2c or higher after mechanical thrombectomy
- •ASPECTS score of greater than 6
- •Premorbid mRS 0-4
- •Signed informed consent within 30 minutes from end of MT procedure.
排除标准
- •Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT scan
- •Pregnant or lactating
- •Acute traumatic brain injury
- •Patient on active dialysis
- •Intracranial neoplasm
- •Acute or recent STEMI in the last 30 days
- •Severe arrhythmias, unstable cardiac function
- •Any terminal medical condition with life expectancy less than 6 months
- •Concurrent enrollment in another trial that could confound the results of this study
研究组 & 干预措施
Intensive blood pressure management group
Target blood pressure of 90-120mmHg (Intensive BP management group)
干预措施: Clevidipine (Drug)
Standard blood pressure management group
Target blood pressure of 90-160mmHg (Standard BP management group)
干预措施: Clevidipine (Drug)
结局指标
主要结局
Primary Efficacy Endpoint (Drug-related)
时间窗: Time from drug initiation to target blood pressure, up to 24 hours after study drug adminstration
Time to target blood pressure
Primary Safety Endpoint (Disease-related)
时间窗: 24 hours from the time of treatment with Clevidipine
Incidence of any hemorrhagic conversion at 24 hours
次要结局
- Drug-related, Rate of hypotension and severe hypertension(Up to 24 hours after study drug adminstration)
- Drug-related(Up to 24 hours after study drug adminstration)
- Disease-related, Incidence of acute kidney injury(From drug adminstration to 90 days post-randomization)
- Disease-related,(90 days after randomization)
- Disease-related, Use of additional hypertensive agents(Up to 24 hours after study drug adminstration)
- Disease-related, Incidence of symptomatic intracerebral hemorrhage(Within 24 hours of randomization)
- Disease-related, Delayed ICH after 24 hours(Within 24 hours of randomization)
- Disease-related, Onset of atrial fibrillation or cardiovascular events(Up to 24 hours after study drug adminstration)
- Drug-related, Rate of hypotension requiring intervention(Up to 24 hours after study drug adminstration)
- Disease-related, Length of hospital stay(Day 6 (+/- 1 day) post-randomization or discharge (whichever sooner))
- Disease-related, mRS 0-2 or return to baseline at 90 days(90 days post-randomization)