Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- National Institutes of Health Stroke Scale score
研究概览
简要总结
About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome in these patients. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter also known as the 'hunger hormone.' Treatment with acylated ghrelin consistently improved functional and histological recovery in in vitro and in vivo models of ischemic stroke.
详细描述
We will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT. The study population will be drawn from adult patients with acute ischemic stroke treated with EVT at UMC Utrecht, Rijnstate, MST or Isala.
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
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
- None
盲法说明
PROBE design
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
- •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).
排除标准
- •pre-stroke disability defined as mRS ≥ 2,
- •life expectancy shorter than one year,
- •child-bearing potential.
研究组 & 干预措施
Ghrelin treatment
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
干预措施: Ghrelin (Drug)
结局指标
主要结局
National Institutes of Health Stroke Scale score
时间窗: 7 days after stroke onset
The primary outcome measure is the score on the National Institutes of Health Stroke Scale at seven days (±1) after stroke onset or at discharge, if earlier. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
次要结局
- National Institutes of Health Stroke Scale score(72 hours after stroke onset)
- Telephonic Montreal Cognitive Assessment(90 days after stroke onset)
- Blood pressure(Days 1-7 after stroke onset)
- Modified Rankin Scale score(90 days after stroke onset)
- Mortality(90 days after stroke onset)
- Infarct size(72 hours after stroke onset)
- Blood glucose levels(Days 1-7 after stroke onset)
- Body temperature(Days 1-7 after stroke onset)