Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage
Efficacy and Safety of Minocycline in Patients With Acute Spontaneous Intracerebral Hemorrhage: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase III Trial
Beijing Tiantan Hospital
1,192 participants
Apr 2, 2026
INTERVENTIONAL
Conditions
Summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. It aims to evaluate the efficacy and safety of oral minocycline in patients with acute spontaneous intracerebral hemorrhage within 48 hours of onset.
Eligibility
Inclusion Criteria6
- CT-confirmed spontaneous supratentorial intracerebral hemorrhage;
- Aged 18 to 80 years;
- Within 48 hours of symptom onset;
- Hematoma volume 15-40 ml;
- NIHSS score 8-24, with item 1a ≤ 2;
- Signed informed consent by the patient or legal representative.
Exclusion Criteria18
- Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.);
- Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles;
- Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage;
- Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment);
- Progressive neurological or other severe systemic diseases;
- Planned surgical intervention for the intracerebral hemorrhage;
- Pre-stroke disability (modified Rankin Scale score > 1);
- Severe cardiac insufficiency (NYHA Class III-IV), severe liver disease (ALT or AST > 3 times the normal upper limit value), severe renal insufficiency (serum creatinine > 2 times the normal upper limit value, or glomerular filtration rate < 45 ml/min), or malignancy with life expectancy < 1 year;
- Moderate to severe anemia (hemoglobin < 90 g/L), thrombocytopenia (platelet count < 100×10\^9/L), leukopenia (white blood cell count < 2×10\^9/L), or coagulopathy (INR > 1.5);
- Allergy or intolerance to minocycline or other tetracycline antibiotics;
- History of pseudomembranous enteritis or antibiotic-associated enteritis;
- Use of tetracycline antibiotics within the past week;
- Intracranial or spinal surgery within the past 3 months;
- Any major surgery or severe physical trauma within the past month;
- Females who are pregnant, within 30 days postpartum, or in the lactation period.
- Participated in other interventional clinical trials within the past 3 months;
- Inability to obtain signed informed consent from the patient or representative;
- Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.
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Interventions
50 mg per capsule, containing 50mg of Minocycline Hydrochloride
50 mg per capsule, containing 0 mg of Minocycline Hydrochloride
Locations(41)
View Full Details on ClinicalTrials.gov
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NCT07338175