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
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
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
Parallel
Minocycline 200mg
DrugMinocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset.
Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke
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
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.
NIHSS Score at 30 Days Post-Stroke
NIHSS scores will be assessed at 30 days (+/- 7 days) post-stroke to evaluate intermediate neurological recovery in both treatment arms.
Rate of Hemorrhagic Transformation of Ischemic Strokes
The incidence of hemorrhagic transformation in ischemic stroke patients treated with IV thrombolytics and/or thrombectomy will be assessed during hospitalization using ECASS ( European Cooperative Acute Stroke Study) II/III criteria via follow-up CT or MRI imaging.
All-Cause Mortality (mRS = 6)
Mortality rates will be measured at Day 7, 30 days (+/- 7 days), and 90 days (+/- 7 days) post-stroke in both treatment groups.
Click on the lead sponsor to view all of their trials.
Joyce Chen
Lead sponsor
Maimonides Medical Center
Sponsor institution
