NCT04775147终止不适用
Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Level of disability
研究概览
简要总结
CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.
详细描述
CRISIS I aims to determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to standard BP management target (<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).
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)
盲法说明
Open intervention; outcome assessments undertaken by trained research staff who are kept blind to treatment allocation
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 years
- •Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging
- •To receive MT <24 hours after AIS onset according to local guidelines
- •Successful recanalization (TICI score ≥2b) after MT
- •Sustained systolic BP ≥140 mmHg (defined as 2 successive readings <10 mins) within 60 minutes after recanalization
- •Provide written informed consent (or approved surrogate)
- •Perform CTA or MRI before endovascular therapy
- •Signed an approved informed consents
排除标准
- •Significant pre-stroke disability (mRS scores 2-5)
- •Definite indication/contraindication to different intensities of BP lowering treatment
- •Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients)
- •Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician
- •Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating
- •Other conditions inappropriate for inclusion judged by investigators
结局指标
主要结局
Level of disability
时间窗: 90 days (3months)
a shift (improvement) in scores (0-6) on the modified Rankin scale
次要结局
- Intracerebral hemorrhage(90 day)
- Death or neurological severity(7 days)
- BP lowering target (<120 mmHg)(3 days)
研究者
研究点 (1)
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