2024-515705-26-00招募中2 期
Multicentre Randomized trial of Ghrelin in anterior circulation ischemic stroke treated with endovascular thrombectomy. A randomized phase 2 trial.
Rijnstate Ziekenhuis Stichting4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier
研究概览
简要总结
The primary objective of this study is to assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation and treated with EVT.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery) confirmed by neuro-imaging (CTA or MRA)
- •treatment with EVT, defined as groin puncture in the angio suite
- •CT or MRI ruling out intracranial hemorrhage
- •a pre-EVT score of at least 10 on the NIHSS
- •age of 18 years or older
- •written informed consent (deferred)
- •possibility to start trial treatment within 6 hours of stroke onset
排除标准
- •pre-stroke disability defined as mRS ≥ 2
- •life expectancy shorter than one year
- •child-bearing potential
结局指标
主要结局
score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier
score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier
次要结局
- the score on the mRS at 90 days (±14) after stroke onset
- the score on Barthel index at 90 days (±14) after stroke onset
- mortality at 90 days (±14)
- scores on the NIHSS at 24 (±6) and 72 (±12) hours after stroke onset
- score on the telephone version of the Montreal Cognitive Assessment (t-MoCA) at 90 days (±14)
- infarct size at day 72 hours (±24) (based on MRI measurements)
- blood glucose levels at days 1-7 (or until discharge)
- blood pressure at days 1-7 (or until discharge)
- body temperature at days 1-7 (or until discharge)
- SAEs
研究者
Prof. dr. J. Hofmeijer
Scientific
Rijnstate Ziekenhuis Stichting
研究点 (4)
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