Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT07338175

Run by

Beijing Tiantan Hospital

People needed

1192

Starts

2026-04-02

Expected to finish

2028-12-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ningbo Second Hospital — Ningbo, Zhejiang, China (enrolling)
• Chongqing Tongnan District People's Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• The Second People's Hospital of Guangdong Province — Guangzhou, Guangdong, China (enrolling)
• Baoding Fourth Central Hospital (Tangxian, Hebei) — Baoding, Hebei, China (enrolling)
• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (enrolling)
• Zunhua People's Hospital — Zunhua, Hebei, China (enrolling)
• Mengzhou Fuxing Hospital — Mengzhou, Henan, China (enrolling)
• Nanle County People's Hospital — Nanle, Henan, China (enrolling)
• Neixiang County People's Hospital — Neixiang, Henan, China (enrolling)
• General Hospital of Pingmei Shenma Medical Group — Pingdingshan, Henan, China (enrolling)
• Puyang County People's Hospital — Puyang, Henan, China (enrolling)
• Yellow River Sanmenxia Hospital — Sanmenxia, Henan, China (enrolling)
• Shangqiu Third People's Hospital — Shangqiu, Henan, China (enrolling)
• Suixian Hospital of Traditional Chinese Medicine — Shangqiu, Henan, China (enrolling)
• Taikang County People's Hospital — Taikang Chengguanzhen, Henan, China (enrolling)
• Henan Sanbo Brain Hospital — Zhengzhou, Henan, China (enrolling)
• Taihe Hospital of Shiyan — Shiyan, Hubei, China (enrolling)
• Liuyang Jili Hospital — Guankou, Hunan, China (enrolling)
• Shaodong People's Hospital — Shaodong, Hunan, China (enrolling)
• Baotou Central Hospital — Baotou, Inner Mongolia, China (enrolling)
• People's Hospital of Inner Mongolia Autonomous Region — Hohhot, Inner Mongolia, China (enrolling)
• Ordos Central Hospital — Ordos, Inner Mongolia, China (enrolling)
• Ulanqab Central Hospital — Ulanqab, Inner Mongolia, China (enrolling)
• Wuyuan County People's Hospital — Wuyuan, Inner Mongolia, China (enrolling)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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