Intracerebral HemorrhagePhase 3MISTICHNCT07338175
Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage
A Phase 3 study testing Minocycline hydrochloride capsules in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 41 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Minocycline hydrochloride capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,192 participants
- Where
- 41 sitesChina
- Study dates
- 2 Apr 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
China41 sites, 41 recruiting
- Recruiting
Baoding Fourth Central Hospital (Tangxian, Hebei)
Baoding, Hebei
Yuntao Di, 15176391949, 15176391949@126.com
- Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
Yu Fan, 13654729916, 13654729916@163.com
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Xingquan Zhao, MD
Yilong Wang, MD
- Recruiting
Binzhou Central Hospital, Shandong Province
Binzhou, Shandong
Shicong Zhou, 15954375895, doctorzsc@163.com
- Recruiting
Chongqing Tongnan District People's Hospital
Chongqing, Chongqing Municipality
Wenhui Fan, 13908362802, 923540597@qq.com
- Recruiting
Dalian Lushunkou District Hospital of Traditional Chinese Medicine
Dalian, Liaoning
Changhao Jiang, 18640937766, jiangchanghao2@163.com
- Recruiting
Kuandian Central Hospital
Dandong, Liaoning
Chuang Feng, 18641579817, 17712084@qq.com
- Recruiting
The Second People's Hospital of Guangdong Province
Guangzhou, Guangdong
Xuying He, 13688877133, aprilrtz@126.com
- Recruiting
Liuyang Jili Hospital
Guankou, Hunan
Yuzhang Bei, 13487494488, 277475748@qq.com
- Recruiting
People's Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia
Weiping Zhao, 18047192306, zhaowp@163.com
- Recruiting
Yiyang Central Hospital
Hunan, Yiyang
Xuezhi Sun, 13647370015, sunxuezhi@163.com
- Recruiting
Yilong County People's Hospital
Jincheng, Sichuan
18380788562, 676962839@qq.com
- Recruiting
Third People's Hospital of Liaocheng City, Shandong Province
Liaocheng, Shandong
Liguo Chang, 17763559299, chliguo@163.com
- Recruiting
Mengzhou Fuxing Hospital
Mengzhou, Henan
Dali Li, 13938140266, drlidali@163.com
- Recruiting
Nanle County People's Hospital
Nanle, Henan
Tingting Zhang, 13503930546, 1024675614@qq.com
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Peipei Gong, 13921490679, ntgpp@ntu.edu.cn
- Recruiting
Neixiang County People's Hospital
Neixiang, Henan
Tieshuan Xue, 15539914986, 15539914986@163.com
- Recruiting
Ningbo Second Hospital
Ningbo, Zhejiang
Feiyu Chen, 15988659916, cfy979619@sina.com
- Recruiting
Ordos Central Hospital
Ordos, Inner Mongolia
Yong Liu, 18647733342, 113358146@qq.com
- Recruiting
General Hospital of Pingmei Shenma Medical Group
Pingdingshan, Henan
18738931113, zyysjwk@sina.com
- Recruiting
Puyang County People's Hospital
Puyang, Henan
Sumin Bai, 18538335396, 494778602@qq.com
- Recruiting
Yellow River Sanmenxia Hospital
Sanmenxia, Henan
Meng Xue, 15039875526, 531897034@qq.com
- Recruiting
451560995@Qq.Com
Shanghai, Shanghai Municipality
Chang Yan, 13681692190
- Recruiting
Shangqiu Third People's Hospital
Shangqiu, Henan
Yong Liu, 13937095949, 552038839@qq.com
- Recruiting
Suixian Hospital of Traditional Chinese Medicine
Shangqiu, Henan
Ying Li, 13619878828, 1074317027@qq.com
- Recruiting
Shaodong People's Hospital
Shaodong, Hunan
Qiong Zhao, 13975970252, 16504980@qq.com
- Recruiting
Taihe Hospital of Shiyan
Shiyan, Hubei
Kuanming Huang, 13986886592, hkm1111@sina.com
- Recruiting
The Fifth People's Hospital of Ningxia Hui Autonomous Region
Shizuishan, Ningxia
Jiqin Yang, 13895329070, 61993234@qq.com
- Recruiting
Siyang Kangda Hospital
Siyang, Jiangsu
Enyong Ma, 18951391898, 452393798@qq.com
- Recruiting
Taikang County People's Hospital
Taikang, Henan
Xinxia Zhao, 15890587206, 15890587206@139.com
- Recruiting
Weihai Wendeng District People's Hospital
Tianfu, Shandong
Jinguo Zhao, 13561852177, zjg52177@163.com
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality
Jialing Wu, 18622271026, zhengxw930@163.com
- Recruiting
Ulanqab Central Hospital
Ulanqab, Inner Mongolia
Haining Mi, 18047409997, 18047409997@163.com
- Recruiting
Weihai Municipal Hospital
Weihai, Shandong
Fangzhou Ma, 15266102650, 724964360@qq.com
- Recruiting
Weihai Municipal Third Hospital
Weihai, Shandong
Zengsheng Yang, 13676313923, 451560995@qq.com
- Recruiting
Wuyuan County People's Hospital
Wuyuan, Inner Mongolia
Yongming Chen, 15647811211, cyongm2010@163.com
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, Shaanxi
Xiongfei Zhao, 15229497558, 523560371@qq.com
- Recruiting
Yingkou Fangda Hospital
Yingkou, Liaoning
Mingli Zhao, 19975989515, zml_024789@qq.com
- Not yet recruiting
Zhangjiakou First Hospital
Zhangjiakou, Hebei
Lizhong Wang, 13722300490, 995563702@qq.com
- Recruiting
Henan Sanbo Brain Hospital
Zhengzhou, Henan
Peng Zhao, 13603454852, 406106650@qq.com
- Recruiting
Zunhua People's Hospital
Zunhua, Hebei
Zhongyuan Zhang, 13903156136, doctorzhongyuan@163.com
About this study
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
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.
Read the detailed description
The aim of this study was to evaluate the efficacy and safety of 5-day Minocycline versus placebo in patients with acute intracerebral hemorrhage within 48 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation at different time points in patients with acute intracerebral hemorrhage within 48 hours of onset.
A total of 1192 participants will be randomized 1:1 to receive either minocycline or matching placebo for 5 days, in addition to guideline-based standard medical care.
The primary objective is to evaluate the effect of Minocycline in improving the level of 90-day mRS score to 0-3 in patients with acute intracerebral hemorrhage within 48 hours of onset.
The trial is divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants are interviewed at screening/baseline period, 72±12 hours, 7±1 days, 90±7 days,180±7 days after randomization, and when events occur.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Minocycline hydrochloride capsules, Placebo capsules of Minocycline hydrochloride capsules
- Keywords
- Intracerebral Hemorrhage, Minocycline, Neuroprotection
- Medical subject headings
- Cerebral Hemorrhage, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline hydrochloride capsulesDrug
50 mg per capsule, containing 50mg of Minocycline Hydrochloride
Placebo capsules of Minocycline hydrochloride capsulesDrug
50 mg per capsule, containing 0 mg of Minocycline Hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebo capsules of Minocycline hydrochloride capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score 0-3
Modified Rankin Scale score
Measured: At 90±7 days after randomization
Secondary outcomes (9)
mRS score
Modified Rankin Scale score
Measured: At 90±7 days and 180±7 days after randomization
Changes in NIHSS score compared with baseline score
NIHSS score
Measured: At 72±12 hours and 7±1 days after randomization
Changes in Glasgow Coma Scale score compared with baseline score
Glasgow Coma Scale score
Measured: At 72±12 hours and 7±1 days after randomization
Early neurological deterioration
Early neurological deterioration is defined as a decrease of ≥2 in GCS score or an increase of ≥4 in NIHSS score caused by non-sedatives/sleeping drugs compared with the baseline level.
Measured: At 72±12 hours and 7±1 days after randomization
Changes in hs-CRP level compared with baseline level
hs-CRP is examined to evaluate the level of systematic inflammation.
Measured: At 72±12 hours and 7±1 days after randomization
Volume of perihematomal edema (PHE)
Volume of perihematomal edema (PHE) on MRI
Measured: At 7±1 days after randomization
EQ-5D-5L utility score
Quality of life assessed by the EQ-5D-5L utility score
Measured: At 90±7 days and 180±7 days after randomization
Recurrent stroke
Recurrent stroke includes ischemic stroke and hemorrhagic stroke.
Measured: At 90±7 days and 180±7 days after randomization
Combined vascular events
Combined vascular events include stroke, myocardial infarction, and vascular death.
Measured: At 90±7 days and 180±7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingquan Zhao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338175
- Sponsor's protocol ID
- MISTICH
- Acronym
- MISTICH
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chang JJ, Kim-Tenser M, Emanuel BA, Jones GM, Chapple K, Alikhani A, Sanossian N, Mack WJ, Tsivgoulis G, Alexandrov AV, Pourmotabbed T. Minocycline and matrix metalloproteinase inhibition in acute intracerebral hemorrhage: a pilot study. Eur J Neurol. 2017 Nov;24(11):1384-1391. doi: 10.1111/ene.13403. Epub 2017 Sep 20.
PubMed 28929560Lu Y, Guan L, Zhang M, Yang Q, Qiu B, Zhou D, Wang Y, Pan Y, Wang L, Zhou X, Qu H, Liao X, Liu L, Zhao X, Bath PM, Johnston SC, Amarenco P, Wang Y, Wang Y. Rationale and Study Design to Assess the Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke (EMPHASIS). Stroke Vasc Neurol. 2025 Dec 23;10(6):786-792. doi: 10.1136/svn-2024-003577.
PubMed 40147820Fouda AY, Newsome AS, Spellicy S, Waller JL, Zhi W, Hess DC, Ergul A, Edwards DJ, Fagan SC, Switzer JA. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Stroke. 2017 Oct;48(10):2885-2887. doi: 10.1161/STROKEAHA.117.018658. Epub 2017 Sep 8.
PubMed 28887388Lampl Y, Boaz M, Gilad R, Lorberboym M, Dabby R, Rapoport A, Anca-Hershkowitz M, Sadeh M. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study. Neurology. 2007 Oct 2;69(14):1404-10. doi: 10.1212/01.wnl.0000277487.04281.db.
PubMed 17909152Wu DC, Jackson-Lewis V, Vila M, Tieu K, Teismann P, Vadseth C, Choi DK, Ischiropoulos H, Przedborski S. Blockade of microglial activation is neuroprotective in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine mouse model of Parkinson disease. J Neurosci. 2002 Mar 1;22(5):1763-71. doi: 10.1523/JNEUROSCI.22-05-01763.2002.
PubMed 11880505Kraus RL, Pasieczny R, Lariosa-Willingham K, Turner MS, Jiang A, Trauger JW. Antioxidant properties of minocycline: neuroprotection in an oxidative stress assay and direct radical-scavenging activity. J Neurochem. 2005 Aug;94(3):819-27. doi: 10.1111/j.1471-4159.2005.03219.x.
PubMed 16033424Lee JM, Yin K, Hsin I, Chen S, Fryer JD, Holtzman DM, Hsu CY, Xu J. Matrix metalloproteinase-9 in cerebral-amyloid-angiopathy-related hemorrhage. J Neurol Sci. 2005 Mar 15;229-230:249-54. doi: 10.1016/j.jns.2004.11.041. Epub 2004 Dec 29.
PubMed 15760647Yrjanheikki J, Tikka T, Keinanen R, Goldsteins G, Chan PH, Koistinaho J. A tetracycline derivative, minocycline, reduces inflammation and protects against focal cerebral ischemia with a wide therapeutic window. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13496-500. doi: 10.1073/pnas.96.23.13496.
PubMed 10557349Garrido-Mesa N, Zarzuelo A, Galvez J. What is behind the non-antibiotic properties of minocycline? Pharmacol Res. 2013 Jan;67(1):18-30. doi: 10.1016/j.phrs.2012.10.006. Epub 2012 Oct 17.
PubMed 23085382Fu Y, Hao J, Zhang N, Ren L, Sun N, Li YJ, Yan Y, Huang D, Yu C, Shi FD. Fingolimod for the treatment of intracerebral hemorrhage: a 2-arm proof-of-concept study. JAMA Neurol. 2014 Sep;71(9):1092-101. doi: 10.1001/jamaneurol.2014.1065.
PubMed 25003359Xue 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.
PubMed 33212054Bai Q, Xue M, Yong VW. Microglia and macrophage phenotypes in intracerebral haemorrhage injury: therapeutic opportunities. Brain. 2020 May 1;143(5):1297-1314. doi: 10.1093/brain/awz393.
PubMed 31919518Puy L, Perbet R, Figeac M, Duchene B, Deramecourt V, Cordonnier C, Berezowski V. Brain Peri-Hematomal Area, a Strategic Interface for Blood Clearance: A Human Neuropathological and Transcriptomic Study. Stroke. 2022 Jun;53(6):2026-2035. doi: 10.1161/STROKEAHA.121.037751. Epub 2022 Apr 25.
PubMed 35465695Li N, Guo J, Kang K, Zhang J, Zhang Z, Liu L, Liu X, Du Y, Wang Y, Zhao X. Cytotoxic Edema and Adverse Clinical Outcomes in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2023 Apr;38(2):414-421. doi: 10.1007/s12028-022-01603-2. Epub 2022 Sep 30.
PubMed 36180765Cordonnier C, Demchuk A, Ziai W, Anderson CS. Intracerebral haemorrhage: current approaches to acute management. Lancet. 2018 Oct 6;392(10154):1257-1268. doi: 10.1016/S0140-6736(18)31878-6.
PubMed 30319113
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07338175
- Acronym / sponsor ID
- MISTICH / MISTICH
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral Hemorrhage, Minocycline, Neuroprotection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,192 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this study was to evaluate the efficacy and safety of 5-day Minocycline versus placebo in patients with acute intracerebral hemorrhage within 48 hours of onset. In addition, we will explore the effect of Minocycline versus placebo on indicators of venous neuroinflammation at different time points in patients with acute intracerebral hemorrhage within 48 hours of onset.
A total of 1192 participants will be randomized 1:1 to receive either minocycline or matching placebo for 5 days, in addition to guideline-based standard medical care.
The primary objective is to evaluate the effect of Minocycline in improving the level of 90-day mRS score to 0-3 in patients with acute intracerebral hemorrhage within 48 hours of onset.
The trial is divided into three phases: screening/baseline period, treatment period, and follow-up period. The visit schedule is as follows: Randomized participants are interviewed at screening/baseline period, 72±12 hours, 7±1 days, 90±7 days,180±7 days after randomization, and when events occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Minocycline treatment group | Experimental | Drug: Minocycline hydrochloride capsulesMinocycline 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). |
| Placebo Comparator: Minocycline placebo-control group | Placebo comparator | Drug: Placebo capsules of Minocycline hydrochloride capsulesPlacebo of Minocycline Hydrochloride capsules (50mg per capsule, containing 0 mg of Minocycline). The method of administration was the same as that of treatment group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline hydrochloride capsules50 mg per capsule, containing 50mg of Minocycline Hydrochloride | Drug | Active Comparator: Minocycline treatment group |
| Placebo capsules of Minocycline hydrochloride capsules50 mg per capsule, containing 0 mg of Minocycline Hydrochloride | Drug | Placebo Comparator: Minocycline placebo-control group |
Primary outcome
mRS score 0-3
Time frame: At 90±7 days after randomization
Modified Rankin Scale score
9 secondary outcomes
mRS score
Time frame: At 90±7 days and 180±7 days after randomization
Changes in NIHSS score compared with baseline score
Time frame: At 72±12 hours and 7±1 days after randomization
Changes in Glasgow Coma Scale score compared with baseline score
Time frame: At 72±12 hours and 7±1 days after randomization
Early neurological deterioration
Time frame: At 72±12 hours and 7±1 days after randomization
Changes in hs-CRP level compared with baseline level
Time frame: At 72±12 hours and 7±1 days after randomization
Volume of perihematomal edema (PHE)
Time frame: At 7±1 days after randomization
EQ-5D-5L utility score
Time frame: At 90±7 days and 180±7 days after randomization
Recurrent stroke
Time frame: At 90±7 days and 180±7 days after randomization
Combined vascular events
Time frame: At 90±7 days and 180±7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Results publication: PubMed 28929560Chang JJ, Kim-Tenser M, Emanuel BA, Jones GM, Chapple K, Alikhani A, Sanossian N, Mack WJ, Tsivgoulis G, Alexandrov AV, Pourmotabbed T. Minocycline and matrix metalloproteinase inhibition in acute intracerebral hemorrhage: a pilot study. Eur J Neurol. 2017 Nov;24(11):1384-1391. doi: 10.1111/ene.13403. Epub 2017 Sep 20.
- Results publication: PubMed 40147820Lu Y, Guan L, Zhang M, Yang Q, Qiu B, Zhou D, Wang Y, Pan Y, Wang L, Zhou X, Qu H, Liao X, Liu L, Zhao X, Bath PM, Johnston SC, Amarenco P, Wang Y, Wang Y. Rationale and Study Design to Assess the Efficacy and Safety of Minocycline in Patients with Moderate to Severe Acute Ischaemic Stroke (EMPHASIS). Stroke Vasc Neurol. 2025 Dec 23;10(6):786-792. doi: 10.1136/svn-2024-003577.
- Results publication: PubMed 28887388Fouda AY, Newsome AS, Spellicy S, Waller JL, Zhi W, Hess DC, Ergul A, Edwards DJ, Fagan SC, Switzer JA. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Stroke. 2017 Oct;48(10):2885-2887. doi: 10.1161/STROKEAHA.117.018658. Epub 2017 Sep 8.
- Results publication: PubMed 17909152Lampl Y, Boaz M, Gilad R, Lorberboym M, Dabby R, Rapoport A, Anca-Hershkowitz M, Sadeh M. Minocycline treatment in acute stroke: an open-label, evaluator-blinded study. Neurology. 2007 Oct 2;69(14):1404-10. doi: 10.1212/01.wnl.0000277487.04281.db.
- Results publication: PubMed 11880505Wu DC, Jackson-Lewis V, Vila M, Tieu K, Teismann P, Vadseth C, Choi DK, Ischiropoulos H, Przedborski S. Blockade of microglial activation is neuroprotective in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine mouse model of Parkinson disease. J Neurosci. 2002 Mar 1;22(5):1763-71. doi: 10.1523/JNEUROSCI.22-05-01763.2002.
- Results publication: PubMed 16033424Kraus RL, Pasieczny R, Lariosa-Willingham K, Turner MS, Jiang A, Trauger JW. Antioxidant properties of minocycline: neuroprotection in an oxidative stress assay and direct radical-scavenging activity. J Neurochem. 2005 Aug;94(3):819-27. doi: 10.1111/j.1471-4159.2005.03219.x.
- Results publication: PubMed 15760647Lee JM, Yin K, Hsin I, Chen S, Fryer JD, Holtzman DM, Hsu CY, Xu J. Matrix metalloproteinase-9 in cerebral-amyloid-angiopathy-related hemorrhage. J Neurol Sci. 2005 Mar 15;229-230:249-54. doi: 10.1016/j.jns.2004.11.041. Epub 2004 Dec 29.
- Results publication: PubMed 10557349Yrjanheikki J, Tikka T, Keinanen R, Goldsteins G, Chan PH, Koistinaho J. A tetracycline derivative, minocycline, reduces inflammation and protects against focal cerebral ischemia with a wide therapeutic window. Proc Natl Acad Sci U S A. 1999 Nov 9;96(23):13496-500. doi: 10.1073/pnas.96.23.13496.
- Results publication: PubMed 23085382Garrido-Mesa N, Zarzuelo A, Galvez J. What is behind the non-antibiotic properties of minocycline? Pharmacol Res. 2013 Jan;67(1):18-30. doi: 10.1016/j.phrs.2012.10.006. Epub 2012 Oct 17.
- Results publication: PubMed 25003359Fu Y, Hao J, Zhang N, Ren L, Sun N, Li YJ, Yan Y, Huang D, Yu C, Shi FD. Fingolimod for the treatment of intracerebral hemorrhage: a 2-arm proof-of-concept study. JAMA Neurol. 2014 Sep;71(9):1092-101. doi: 10.1001/jamaneurol.2014.1065.
- Results publication: PubMed 33212054Xue 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.
- Results publication: PubMed 31919518Bai Q, Xue M, Yong VW. Microglia and macrophage phenotypes in intracerebral haemorrhage injury: therapeutic opportunities. Brain. 2020 May 1;143(5):1297-1314. doi: 10.1093/brain/awz393.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline hydrochloride capsules in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 41 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaijiang Kang, MD (+86 59975701, kangkaijiang678@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score 0-3 (time frame: At 90±7 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338175, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.