Effect of Oral Minocycline in Patients With Acute Stroke - a Randomized, Open Label, Prospective Trial
Joyce Chen
Summary
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
Description
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 s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
\* Inclusion criteria In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Age \>/=18 2. NIHSS 5-20 \*National Institutes of Health Stroke Scale\* 3. 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 4. The onset of neurological symptoms less than 24 hours * Exclusion criteria An individu…
Interventions
- DrugMinocycline 200mg
Minocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset.
Location
- Maimonides Medical CenterBrooklyn, New York