Minocycline treatment for acute spontaneous intracerebral hemorrhage.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial will randomize 1,192 adults with CT-confirmed supratentorial intracerebral hemorrhage to receive either oral minocycline or matching placebo for five days in addition to guideline-based care. Eligible participants must be enrolled within 48 hours of symptom onset and have hematoma volumes of 15–40 ml and NIHSS scores of 8–24. The primary outcome is the proportion achieving a favorable 90-day modified Rankin Scale score (0–3), with clinical follow-up at 72 hours, 7 days, 90 days, and 180 days. Exploratory analyses will measure markers of neuroinflammation at predefined time points to explore biological effects of minocycline.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chongqing Tongnan District People's Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• The Second People's Hospital of Guangdong Province
  Guangzhou, Guangdong, China Recruiting
• Baoding Fourth Central Hospital (Tangxian, Hebei)
  Baoding, Hebei, China Recruiting
• Zunhua People's Hospital
  Zunhua, Hebei, China Recruiting
• Mengzhou Fuxing Hospital
  Mengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Kaijiang Kang, MD
• Email: kangkaijiang678@126.com
• Phone: +86 59975701

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.