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RECRUITING

NCT07338175

PHASE3

Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1192

Start Date

2026-04-02

Completion Date

2028-12

Last Updated

2026-04-23

Healthy Volunteers

Conditions

Intracerebral Hemorrhage

Interventions

DRUG

Minocycline hydrochloride capsules

50 mg per capsule, containing 50mg of Minocycline Hydrochloride

DRUG

Placebo capsules of Minocycline hydrochloride capsules

50 mg per capsule, containing 0 mg of Minocycline Hydrochloride

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.

Locations (41)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Chongqing Tongnan District People's Hospital

Chongqing, Chongqing Municipality, China

The Second People's Hospital of Guangdong Province

Guangzhou, Guangdong, China

Baoding Fourth Central Hospital (Tangxian, Hebei)

Baoding, Hebei, China

Zhangjiakou First Hospital

Zhangjiakou, Hebei, China

Zunhua People's Hospital

Zunhua, Hebei, China

Mengzhou Fuxing Hospital

Mengzhou, Henan, China

Nanle County People's Hospital

Nanle, Henan, China

Neixiang County People's Hospital

Neixiang, Henan, China

General Hospital of Pingmei Shenma Medical Group

Pingdingshan, Henan, China

Puyang County People's Hospital

Puyang, Henan, China

Yellow River Sanmenxia Hospital

Sanmenxia, Henan, China

Shangqiu Third People's Hospital

Shangqiu, Henan, China

Suixian Hospital of Traditional Chinese Medicine

Shangqiu, Henan, China

Taikang County People's Hospital

Taikang Chengguanzhen, Henan, China

Henan Sanbo Brain Hospital

Zhengzhou, Henan, China

Taihe Hospital of Shiyan

Shiyan, Hubei, China

Liuyang Jili Hospital

Guankou, Hunan, China

Shaodong People's Hospital

Shaodong, Hunan, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

People's Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

Ordos Central Hospital

Ordos, Inner Mongolia, China

Ulanqab Central Hospital

Ulanqab, Inner Mongolia, China

Wuyuan County People's Hospital

Wuyuan, Inner Mongolia, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Siyang Kangda Hospital

Siyang, Jiangsu, China

Dalian Lushunkou District Hospital of Traditional Chinese Medicine

Dalian, Liaoning, China

Kuandian Central Hospital

Dandong, Liaoning, China

Yingkou Fangda Hospital

Yingkou, Liaoning, China

The Fifth People's Hospital of Ningxia Hui Autonomous Region

Shizuishan, Ningxia, China

Xianyang Hospital of Yan'an University

Xianyang, Shaanxi, China

Binzhou Central Hospital, Shandong Province

Binzhou, Shandong, China

Third People's Hospital of Liaocheng City, Shandong Province

Liaocheng, Shandong, China

Weihai Wendeng District People's Hospital

Tianfu, Shandong, China

Weihai Municipal Hospital

Weihai, Shandong, China

Weihai Municipal Third Hospital

Weihai, Shandong, China

451560995@Qq.Com

Shanghai, Shanghai Municipality, China

Yilong County People's Hospital

Jincheng, Sichuan, China

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Yiyang Central Hospital

Hunan, Yiyang, China

Ningbo Second Hospital

Ningbo, Zhejiang, China