About this trial
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:
1. Does Minocycline improve \*National Institutes of Health Stroke Scale\* (NIHSS) scores at hospital discharge and 90 days post-stroke? 2. 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:
1. 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
Eligibility criteria
Qualifiers
Age >/=18
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Minocycline 200mg
Treatment groups
Sponsors and collaborators
Joyce Chen
Lead sponsor
Maimonides Medical Center
Sponsor institution