Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage

NCT07338175 | Recruiting Phase 3 DMC

• 1 other identifier: MISTICH
• Study Type: interventional
• Target: 1,192
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Minocycline; Neuroprotection

Outcome Measures

Primary Outcomes (1)

• mRS score 0-3

  Modified Rankin Scale score

  At 90±7 days after randomization

Secondary Outcomes (9)

• mRS score

  At 90±7 days and 180±7 days after randomization

• Changes in NIHSS score compared with baseline score

  At 72±12 hours and 7±1 days after randomization

• Changes in Glasgow Coma Scale score compared with baseline score

  At 72±12 hours and 7±1 days after randomization

• Early neurological deterioration

  At 72±12 hours and 7±1 days after randomization

• Changes in hs-CRP level compared with baseline level

  At 72±12 hours and 7±1 days after randomization

Other Outcomes (7)

• Changes in the levels of venous neuroinflammation indicators compared with baseline levels

  At 72±12 hours and 7±1 days after randomization

• Perihematomal blood-brain barrier permeability

  At 7±1 days after randomization

• Hematoma expansion or rebleeding

  At 72±12 hours and 7±1 days after randomization

Study Arms (2)

Active Comparator: Minocycline treatment group

EXPERIMENTAL

Minocycline Hydrochloride Capsules (50 mg per capsule). The first dose (200mg, 4 capsules) should be given immediately after randomization (within 30 minutes); Subsequently, 100mg (2 capsules) will be administered once every 12 hours; a total of 10 times (lasting 5 days; the subject with dysphagia will be administrated through a nasal feeding tube).

Drug: Minocycline hydrochloride capsules

Placebo Comparator: Minocycline placebo-control group

PLACEBO COMPARATOR

Placebo of Minocycline Hydrochloride capsules (50mg per capsule, containing 0 mg of Minocycline). The method of administration was the same as that of treatment group.

Drug: Placebo capsules of Minocycline hydrochloride capsules

Interventions

Minocycline hydrochloride capsules DRUG

50 mg per capsule, containing 50mg of Minocycline Hydrochloride

Active Comparator: Minocycline treatment group

Placebo capsules of Minocycline hydrochloride capsules DRUG

50 mg per capsule, containing 0 mg of Minocycline Hydrochloride

Placebo Comparator: Minocycline placebo-control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (41)

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

Zhangjiakou First Hospital

Zhangjiakou, Hebei, China

NOT YET RECRUITING

Zunhua People's Hospital

Zunhua, Hebei, China

RECRUITING

Mengzhou Fuxing Hospital

Mengzhou, Henan, China

RECRUITING

Nanle County People's Hospital

Nanle, Henan, China

RECRUITING

Neixiang County People's Hospital

Neixiang, Henan, China

RECRUITING

General Hospital of Pingmei Shenma Medical Group

Pingdingshan, Henan, China

RECRUITING

Puyang County People's Hospital

Puyang, Henan, China

RECRUITING

Yellow River Sanmenxia Hospital

Sanmenxia, Henan, China

RECRUITING

Shangqiu Third People's Hospital

Shangqiu, Henan, China

RECRUITING

Suixian Hospital of Traditional Chinese Medicine

Shangqiu, Henan, China

RECRUITING

Taikang County People's Hospital

Taikang Chengguanzhen, Henan, China

RECRUITING

Henan Sanbo Brain Hospital

Zhengzhou, Henan, China

RECRUITING

Taihe Hospital of Shiyan

Shiyan, Hubei, China

RECRUITING

Liuyang Jili Hospital

Guankou, Hunan, China

RECRUITING

Shaodong People's Hospital

Shaodong, Hunan, China

RECRUITING

Baotou Central Hospital

Baotou, Inner Mongolia, China

RECRUITING

People's Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

RECRUITING

Ordos Central Hospital

Ordos, Inner Mongolia, China

RECRUITING

Ulanqab Central Hospital

Ulanqab, Inner Mongolia, China

RECRUITING

Wuyuan County People's Hospital

Wuyuan, Inner Mongolia, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Siyang Kangda Hospital

Siyang, Jiangsu, China

RECRUITING

Dalian Lushunkou District Hospital of Traditional Chinese Medicine

Dalian, Liaoning, China

RECRUITING

Kuandian Central Hospital

Dandong, Liaoning, China

RECRUITING

Yingkou Fangda Hospital

Yingkou, Liaoning, China

RECRUITING

The Fifth People's Hospital of Ningxia Hui Autonomous Region

Shizuishan, Ningxia, China

RECRUITING

Xianyang Hospital of Yan'an University

Xianyang, Shaanxi, China

RECRUITING

Binzhou Central Hospital, Shandong Province

Binzhou, Shandong, China

RECRUITING

Third People's Hospital of Liaocheng City, Shandong Province

Liaocheng, Shandong, China

RECRUITING

Weihai Wendeng District People's Hospital

Tianfu, Shandong, China

RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, China

RECRUITING

Weihai Municipal Third Hospital

Weihai, Shandong, China

RECRUITING

451560995@Qq.Com

Shanghai, Shanghai Municipality, China

RECRUITING

Yilong County People's Hospital

Jincheng, Sichuan, China

RECRUITING

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Yiyang Central Hospital

Hunan, Yiyang, China

RECRUITING

Ningbo Second Hospital

Ningbo, Zhejiang, China

RECRUITING

Related Publications (25)

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• Xue M, Yong VW. Neuroinflammation in intracerebral haemorrhage: immunotherapies with potential for translation. Lancet Neurol. 2020 Dec;19(12):1023-1032. doi: 10.1016/S1474-4422(20)30364-1.

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MeSH Terms

Conditions

Cerebral Hemorrhage; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Kaijiang Kang, MD

CONTACT

+86 59975701; kangkaijiang678@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (41)