Second Enhanced Control of Hypertension and Thrombectomy Stroke Study (ENCHANTED2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 816
- 试验地点
- 1
- 主要终点
- Level of disability
研究概览
简要总结
ENCHANTED2 is an international, multicenter, prospective, randomised, open, blinded end-point assessed (PROBE) trial, to assess different approaches to manage blood pressure (BP) in acute ischemic stroke (AIS) patients who have undergone mechanical thrombectomy (MT). There are two nested substudies evaluating different approaches to secondary prevention in this high-risk stroke population.
详细描述
Objectives: To determine the effectiveness of more intensive BP lowering target (<120 mmHg) compared to higher BP management target (140-180mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to large vessel occlusion (LVO).
Inclusion Criteria:
- Age ≥18 years;
- Diagnosis of AIS with 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 3 hours after recanalization;
- Provide written informed consent (or approved surrogate).
Exclusion Criteria:
- 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. known significant pre-stroke disability (mRS scores 3-5), advance cancer and renal failure);
- 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);
- Patients with aortic isthmus stenosis and arteriovenous shunt (exception: patients with haemodynamically inactive dialysis shunt);
- Women who are lactating;
- Currently participating in another trial which would interfere with outcome assessments.
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 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 3 hours after recanalization; Provide written informed consent (or approved surrogate).
排除标准
- •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. known significant pre-stroke disability (mRS scores 3-5), advance cancer and renal failure); 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); Patients with aortic isthmus stenosis and arteriovenous shunt (exception: patients with haemodynamically inactive dialysis shunt); Women who are lactating; Currently participating in another trial which would interfere with outcome assessments.
结局指标
主要结局
Level of disability
时间窗: 90 days (3 months)
a shift (improvement) in scores (0-6) on the modified Rankin scale
次要结局
- Imaging endpoints(Day 7)
- Death or neurological severity(7 days)
- Others(90 days)
- intracerebral hemorrhage (ICH)(90 days)
研究者
Craig Anderson
Executive Director
The George Institute for Global Health, China