Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy: A Phase II, Randomized, Multicenter, Double-blind, Single Dose, Placebo-controlled Parallel Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes of NIHSS score between baseline and at 7 days after randomization.
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of Sarecycline versus placebo in the treatment of microcirculation dysfunction after reperfusion therapy in patients with large vessel occlusion stroke.
详细描述
This study evaluated the efficacy and safety of 7-day Sarecycline versus placebo in patients with large vessel occlusion stroke who received reperfusion therapy within 24 hours of onset. In addition, we will explore the effect of Sarecycline versus placebo on indicators of venous thrombotic inflammation at different time points in patients with acute ischemic stroke with large vessel occlusion.
This trial was a prospective, randomized, multicenter, double-blind, placebo-controlled parallel trial. Patients with acute large vessel occlusion stroke who received reperfusion therapy within 24 hours of onset were randomly assigned according to the ratio of the experimental group: control group =2:1.
The trial was divided into three phases: screening/baseline period, treatment period, and follow-up period. The primary research objective is to evaluate the effect of Sarecycline in improving neurological deficits at 7 days in patients with acute large vessel occlusion stroke who received reperfusion therapy within 24 hours of onset.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The Sarecycline drug used in the study is indistinguishable from the Sarecycline placebo (the shape, color, and appearance are identical).
In addition, to ensure the blind method, the drug packaging and batch numbers of the two groups are identical, and the packaging batch numbers are uniformly marked.
During the implementation of the study, except for the authorized personnel of the company's supply chain, research management department, and subject security department, members of each research execution group, research center personnel, and CRO data processing personnel cannot view the randomization scheme.
The blind method was also used to evaluate the outcome. The subjects were randomly divided into groups and blinded to the members of the adjudication committee.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sarecycline treatment group
The first dose should be given immediately after randomization (within 30 minutes); Take one tablet once a day for 7 days continuously (the patient with dysphagia will be administrated through a nasal feeding tube).
干预措施: Sarecycline Tablet (Drug)
Sarecycline placebo control group
The control group received Sarecycline placebo tablets (each containing Sarecycline 0 mg) in the same way as the experimental group.
干预措施: Placebo tablets of Sarecycline tablets (Drug)
结局指标
主要结局
Changes of NIHSS score between baseline and at 7 days after randomization.
时间窗: at 7 days after randomization
National Institute of Health stroke scale (NIHSS 0-42 scores; higher scores mean a worse outcome）
次要结局
- Early neurological deterioration at 72 hours after randomization.(at 72 hours after randomization.)
- Early neurological deterioration at 7 days after randomization.(at 7 days after randomization)
- Quality of life (EQ-5D) score at 90 days after randomization.(at 90 days after randomization)
- Changes of NIHSS score between baseline and within 2 hours after reperfusion.(within 2 hours after reperfusion)
- Changes of NIHSS score between baseline and 72 hours after randomization.(at 72 hours after randomization)
- Changes of infarction volume between baseline and at 72 hours after randomization.(at 72 hours after randomization)
- Changes of cerebral blood perfusion between baseline and at 72 hours after randomization.(at 72 hours after randomization)
- The proportion of combined vascular events (recurrent stroke, myocardial infarction, and vasogenic death) at 90 days after randomization.(at 90 days after randomization)
- Modified Rankin Scale (mRS) score at 90 days after randomization.(at 90 days after randomization)
- Changes of collateral circulation compensation between baseline and at 72 hours after randomization.(at 72 hours after randomization)
研究者
yilong Wang
Vice President of Beijing Tiantan Hospital
Beijing Tiantan Hospital