JPRN-jRCT2031230083招募中2 期
A phase 2b, multinational, randomized, double-blind study to investigate the efficacy and safety of redasemtide (S 005151) compared with placebo in adult participants with acute ischemic stroke who are not eligible for tissue plasminogen activator or thrombectomy
Gomez Juan Carlos0 个研究点目标入组 627 人开始时间: 2023年5月20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
- 627
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Male or female adults >= 18 years of age (or complies with country-specific regulatory requirements) at the time of obtaining informed consent
- •- Diagnosis of supratentorial (including anterior and posterior circulation) ischemic stroke as the main infarction site, confirmed by computed tomography (CT) scan or magnetic resonance imaging (MRI) at the time of screening. The CT imaging criteria are hypodensity, perfusion deficit, or vessel occlusion in the anterior or posterior circulation
- •- Able to initiate study intervention within 25 hours of stroke onset (if the onset time is unknown, the last time at which the participant was known to be healthy is regarded as the onset time ['last known to be well'])
- •- Determined by the investigator to not be eligible for recanalization thrombolysis or endovascular recanalization therapy (ie, mechanical thrombectomy, local fibrinolytic therapy) for the current stroke. (Note: Participants who underwent mechanical thrombectomy, but a stent could not be placed to reach the occluded vessel site may be eligible for this study)
- •- Baseline NIHSS score of 8 to 22 (inclusive) and stable, defined as absence of an increase or decrease of >= 4 points within >= 1 hour to =< 3 hours between screening and baseline assessment of NIHSS score
排除标准
- •- A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Not alert, responds only with reflex motor or autonomic effects, or totally unresponsive, flaccid, and areflexic)
- •- Disability corresponding to a mRS score of >= 2 before the onset of stroke
- •- A history of stroke (excluding transient ischemic attack), history of or current intracranial hemorrhage, or head trauma that caused neurological effects within 90 days prior to obtaining informed consent
- •- Participants with an ischemic stroke in cerebellum and/or brain stem as the main infarction site
- •- Diagnosis of a current transient ischemic attack
- •- Unable to undergo either CT or MRI
- •- Considered by the investigator to be inappropriate to participate due to a history or complication of serious cardiovascular disease within 1 month of screening (eg, history of acute myocardial infarction, current acute myocardial infarction, uncontrollable heart failure, infective endocarditis requiring treatment, or acute aortic dissection, or requiring or likely to require hospitalization for severe arrhythmia during the study)
- •- Blood glucose level < 50 or > 400 mg/dL after glycemic control
- •- Systolic blood pressure >= 220 mm Hg or diastolic blood pressure >= 120 mm Hg after antihypertensive treatment
- •- Current or ongoing anticancer treatment; however, nonmelanoma skin cancer or lesions equivalent to intramucosal cancer or carcinoma in situ curable by endoscopic resection may be eligible for this study
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