Effect of Oral Minocycline on Acute Stroke Outcome: A Randomized Open Label Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- In-hospital and 30-day Mortality
研究概览
简要总结
The goal of this study is to determine if oral Minocycline's proposed neuroprotective effects further improve the clinical outcomes, including mortality, of acute stroke patients beyond the current standard stroke care in a large scale randomized prospective open label (outcome assessor blinded) clinical trial.
Participants will be randomly assigned (1:1) to take Minocycline 200mg orally every 24 hours for five days, starting within 24 hours from stroke symptoms onset, in addition to standard care or standard care alone.
NIHSS (The National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) will be collected at the time of presentation, discharge and again at 30- and 90-days post-discharge. All-cause mortality will also be obtained at 30 days and 90 days.
详细描述
Studies on animals and humans have shown that Minocycline, a widely used semi-synthetic antibiotic, may protect the brain, spinal cord and nervous system from injuries such as ischemia, trauma, neurodegeneration or inflammation. Minocycline has been shown possibly to reduce the disability and recovery time from stroke.
Hypothesis:
When combined with the standard care treatment, Minocycline's neuroprotective effects improve the clinical outcomes, including the mortality, of acute stroke patients compared to the standard stroke care without Minocycline.
Minocycline 200mg daily, when administered less than 24 hours after onset of acute ischemic stroke orally, improves survival and functional outcome as assessed by improvement of NIHSS - (National Institutes of Health Stroke Scale) score and mRS (Modified Rankin Scale) scores on admission and at discharge (including mortality, mRS=6) and on day 90 post-stroke.
This prospective study will enroll 1120 patients who arrive in the ER at Maimonides Medical Center for suspected acute stroke (excluding transient ischemic attack). After obtaining informed consent, 1120 patients will be enrolled from November 2023 to November 2025. Consecutive randomization will be done, and 560 patients will be assigned to each arm, the Minocycline with Standard care and Standard Care alone arms. The 560 patients in the Minocycline arm will receive Minocycline 200 mg orally every 24 hours for five days in addition to standard care, while the Standard arm will accept only standard care. NIHSS -(National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) scores will be collected on presentation, on discharge, and days 30 and 90. A comparison will be made between both arms in both studies for their significance. Statistical analysis will be done with the help of a Maimonides statistician. Interim research will be conducted every six months for outcome significance and safety measures (30-day mortality and symptomatic hemorrhagic conversion).
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
Outcome assessors will contact and obtain primary outcome measures of mRS without the knowledge of participants group assignment/treatment received.
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
- •Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO (World Health Organization) guidelines
- •Acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed
- •The onset of symptoms less than 24 hours
- •Measurable neurological deficit using NIHSS (National Institutes of Health Stroke Scale )
排除标准
- •Clinically not suspect stroke.
- •Allergic to the Tetracycline group of medications or Intolerance to Minocycline
- •Pregnancy or suspected pregnancy
- •Previous history of intolerance to minocycline
- •Acute or chronic renal failure
- •Any patients with contraindications to undergo CT/ MRI
- •Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission
- •Pre-existing infectious disease requiring antibiotics
- •Inability to tolerate enteral medications/feeds
- •Patient/ family refusal
研究组 & 干预措施
Standard Stroke Care with Minocycline
560 patients in the Minocycline arm will receive Minocycline 200 mg every 24 hours for five days with standard stroke care
干预措施: Minocycline (Drug)
结局指标
主要结局
In-hospital and 30-day Mortality
时间窗: 30 days
Mortality rates during hospitalization and at 30 days
次要结局
未报告次要终点
研究者
Qingliang T. Wang
MD, PhD, Vice Chair of Neurology; Director of Jaffe Comprehensive Stroke Center
Maimonides Medical Center