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Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage

RecruitingPhase 3Ages 18 Years - 80 YearsAllBeijing Tiantan Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. CT-confirmed spontaneous supratentorial intracerebral hemorrhage; 2. Aged 18 to 80 years; 3. Within 48 hours of symptom onset; 4. Hematoma volume 15-40 ml; 5. NIHSS score 8-24, with item 1a ≤ 2; 6. Signed informed consent by the patient or legal representative. Exclusion Criteria: 1. Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.); 2. Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles; 3. Significant subarachnoid hemorrhage (Fisher grade ≥ 3) or subdural hemorrhage; 4. Patients with uncontrollable hypertension ( systolic blood pressure persistently ≥ 180 mmHg despite intensive antihypertensive treatment); 5. Progressive neurological or other severe systemic diseases; 6. Planned surgical intervention for the intracerebral hemorrhage; 7. Pre-stroke disability (modified Rankin Scale score \> 1); 8. 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; 9. 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); 10. Allergy or intolerance to minocycline or other tetracycline antibiotics; 11. History of pseudomembranous enteritis or antibiotic-associated enteritis; 12. Use of tetracycline antibiotics within the past week; 13. Intracranial or spinal surgery within the past 3 months; 14. Any major surgery or severe physical trauma within the past month; 15. Females who are pregnant, within 30 days postpartum, or in the lactation period. 16. Participated in other interventional clinical trials within the past 3 months; 17. Inability to obtain signed informed consent from the patient or representative; 18. 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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What it tests

  • Minocycline hydrochloride capsules
  • Placebo capsules of Minocycline hydrochloride capsules
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Where

41 sites
Beijing Tiantan Hospital
Beijing, China
Chongqing Tongnan District People's Hospital
Chongqing, China
The Second People's Hospital of Guangdong Province
Guangzhou, China
Baoding Fourth Central Hospital (Tangxian, Hebei)
Baoding, China
Zhangjiakou First Hospital
Zhangjiakou, China
Zunhua People's Hospital
Zunhua, China
Mengzhou Fuxing Hospital
Mengzhou, China
Nanle County People's Hospital
Nanle, China

…and 33 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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