Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,164
- 试验地点
- 1
- 主要终点
- Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke
研究概览
简要总结
The goal of this study is to determine if Minocycline, when added to standard care, can improve survival and functional outcomes in patients with moderate acute stroke (ischemic or hemorrhagic) aged 18 years and older.
The main questions it aims to answer are:
- Does Minocycline improve *National Institutes of Health Stroke Scale* (NIHSS) scores at hospital discharge and 90 days post-stroke?
- Does Minocycline reduce stroke-related disability, all-cause in hospital mortality (mRS -*Modified Rankin Scale* = 6) and at 90 days besides reducing brain bleeding complications compared to standard care?
Researchers will compare patients receiving oral Minocycline plus standard care to those receiving standard care only to see if Minocycline leads to better neurological outcomes and lower mortality.
Participants will:
- Be randomly assigned by block to receive either:
Minocycline 200 mg orally once daily for five days within 24 hours from symptoms onset + Standard Care, or Standard Care only 2. Undergo neurological assessments using NIHSS *National Institutes of Health Stroke Scale* and Modified Rankin Scale (mRS) at admission, discharge, 30 days post-stroke, 90 days post-stroke 3. Be monitored for: a) hemorrhagic transformation of ischemic strokes; b) Adverse events and mortality outcomes; c) Safety and efficacy signals through interim analyses
NIHSS: *National Institutes of Health Stroke Scale*, which is stroke severity scale,
mRS: *Modified Rankin Scale*, which is stroke disability scale
详细描述
Stroke is a major cause of death and disability in the United States. While treatments such as clot-busting drugs (tPA or TNK) and thrombectomy can help some patients with ischemic strokes, there are limited options for protecting the brain after a stroke. Minocycline is a low-cost antibiotic that may have protective effects on the brain due to its anti-inflammatory and neuroprotective properties.
At Maimonides Medical Center, we have used Minocycline for all eligible patients with acute strokes in clinical practice until March 2019, Studies found that Minocycline was associated with better stroke outcomes and lower death rates, especially in patients with moderate stroke severity. However, no large, randomized trial has yet confirmed its benefits.
This study will prospectively enroll 1,164 adults with moderate stroke (National Institutes of Health Stroke Scale 5-20) within 24 hours of symptom onset. Participants will be assigned by block randomization to receive either:
Minocycline 200 mg orally once daily for 5 days + standard stroke care, or Standard stroke care alone.
The study will measure stroke severity (using the *NIHSS*- National Institutes of Health Stroke Scale) and disability (using the mRS - *modified Rankin Scale*) at hospital discharge, 30 days, and 90 days. It will also monitor for death and any bleeding complications in the brain.
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
This is an outcome assessor-blinded study. Independent outcome assessor will contact participants and obtain primary outcome measures of mRS *(Modified Rankin Scale) * and NIHSS *(National Institute of Stroke Scale) * without the knowledge of participants group assignment/treatment received to reduce the bias and improve validity.
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
- •* Inclusion criteria
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •NIHSS 5-20 *National Institutes of Health Stroke Scale*
- •Acute onset neurological deficit consistent with acute ischemic stroke or on imaging consistent with acute ischemia as defined by WHO *(World Health Organization) * guidelines or acute onset of neurological deficits with intracerebral Hemorrhage on imaging consistent with intracerebral bleed
- •The onset of neurological symptoms less than 24 hours
排除标准
- •An individual who meets any of the following criteria is excluded from participation in this study:
- •Clinically stroke is not suspected
- •Allergic to the Tetracycline group of medications or Intolerance to Minocycline
- •Pregnancy or suspected pregnancy or breastfeeding
- •Previous history of intolerance to Minocycline
- •Acute or chronic renal failure (stage III with GFR *(Glomerular Filtration Rate) * or Creatinine threshold)
- •Any patients with contraindications to undergo CT (Computed Tomography) / MRI (Magnetic Resonance Imaging)
- •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
582 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 200mg (Drug)
Standard Stroke Care without Minocycline
582 Patients in this arm will receive standard stroke care, No Minocycline will be given
结局指标
主要结局
Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke
时间窗: At day 7 after stroke onset
The NIHSS score will be assessed at Day 7 post-stroke to measure neurological impairment and recovery. The primary outcome is the difference in NIHSS scores between the Minocycline plus standard care group and the standard care alone group.
Change in National Institutes of Health Stroke Scale (NIHSS) Score at 90 days (+/- 7 days) post-stroke
时间窗: At 90 days (+/- 7 days) after stroke onset
The NIHSS score will be assessed 90 days (+/- 7 days) post-stroke to measure neurological impairment and recovery. The primary outcome is the difference in NIHSS scores between the Minocycline plus standard care group and the standard care alone group.
次要结局
- NIHSS Score at 30 Days Post-Stroke(up to 30 days after stroke onset)
- Rate of Hemorrhagic Transformation of Ischemic Strokes(22-36 hours post treatment)
- All-Cause Mortality (mRS = 6)(Up to 90 days (±7 days) after stroke onset)
研究者
Joyce Chen
Clinical Data Analyst
Maimonides Medical Center