Recruiting
Phase 2
Phase 3

Minocycline with Standard Care

Sponsor:

Joyce Chen

Code:

NCT07237048

Conditions

Stroke

Ischemia Stroke

Hemorrhagic Strokes

Mortality

Morbidity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Minocycline 200mg

Study Details

Brief 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

Conditions

Stroke

Ischemia Stroke

Hemorrhagic Strokes

Mortality

Morbidity

Study ID

NCT07237048

Start date

Feb 2, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

\* 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 individual who meets any of the following criteria is excluded from participation in this study:

1. Clinically stroke is not suspected
2. Allergic to the Tetracycline group of medications or Intolerance to Minocycline
3. Pregnancy or suspected pregnancy or breastfeeding
4. Previous history of intolerance to Minocycline
5. Acute or chronic renal failure (stage III with GFR \*(Glomerular Filtration Rate) \* or Creatinine threshold)
6. Any patients with contraindications to undergo CT (Computed Tomography) / MRI (Magnetic Resonance Imaging)
7. Life expectancy less than one year or severe co-morbidities or comfort measure only (CMO) on admission
8. Pre-existing infectious disease requiring antibiotics
9. Inability to tolerate enteral medications/feeds
10. Patient/ family refusal

Study Design

Enrollment

1164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard Stroke Care without Minocycline

582 Patients in this arm will receive standard stroke care, No Minocycline will be given

experimental: 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

Interventions

Minocycline 200mg

Minocycline 200 mg every 24 hours for five days to be initiated within 24hr of stroke onset.

Primary outcome measure

  • Change in National Institutes of Health Stroke Scale (NIHSS) Score at Day 7 post stroke [ Time Frame: At day 7 after stroke onset ]
  • Change in National Institutes of Health Stroke Scale (NIHSS) Score at 90 days (+/- 7 days) post-stroke [ Time Frame: At 90 days (+/- 7 days) after stroke onset ]

Central Contacts and Locations

Central contacts

Qingliang T. Wang, MD, PhD

718.283.7670qwang@maimo.org

Ilya Levin, DO

718.283.8681

Locations

Maimonides Medical Center

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Qing Tony Wang, MD

718-283-7670qwang@maimo.org

More Information

Sponsor

Joyce Chen

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • Minocycline
  • Acute Stroke
  • Neuroprotection
  • Ischemic Stroke
  • Hemorrhagic Stroke
  • NIH Stroke Scale
  • Modified Rankin Scale (mRS)
  • Stroke Recovery
  • Stroke Treatment
  • Stroke Outcomes
  • Morbidity
  • Mortality
  • Intravenous Thrombolysis
  • Mechanical Thrombectomy
  • Hemorrhagic Transformation
  • Oral antibiotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joyce Chen on 2026-03-19.