Efficacy and Safety of Minocycline in Acute Spontaneous Intracerebral Hemorrhage (MISTICH)

April 19, 2026 updated by: Xingquan Zhao, Beijing Tiantan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Tiantan Hospital
        • Principal Investigator:
          • Yilong Wang, MD
        • Principal Investigator:
          • Xingquan Zhao, MD
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • Chongqing Tongnan District People's Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Second People's Hospital of Guangdong Province
        • Contact:
    • Hebei
      • Baoding, Hebei, China
        • Recruiting
        • Baoding Fourth Central Hospital (Tangxian, Hebei)
        • Contact:
      • Zhangjiakou, Hebei, China
        • Not yet recruiting
        • Zhangjiakou First Hospital
        • Contact:
      • Zunhua, Hebei, China
        • Recruiting
        • Zunhua People's Hospital
        • Contact:
    • Henan
      • Mengzhou, Henan, China
        • Recruiting
        • Mengzhou Fuxing Hospital
        • Contact:
      • Nanle, Henan, China
        • Recruiting
        • Nanle County People's Hospital
        • Contact:
      • Neixiang, Henan, China
        • Recruiting
        • Neixiang County People's Hospital
        • Contact:
      • Pingdingshan, Henan, China
        • Recruiting
        • General Hospital of Pingmei Shenma Medical Group
        • Contact:
      • Puyang, Henan, China
        • Recruiting
        • Puyang County People's Hospital
        • Contact:
      • Sanmenxia, Henan, China
        • Recruiting
        • Yellow River Sanmenxia Hospital
        • Contact:
      • Shangqiu, Henan, China
        • Recruiting
        • Suixian Hospital of Traditional Chinese Medicine
        • Contact:
      • Shangqiu, Henan, China
        • Recruiting
        • Shangqiu Third People's Hospital
        • Contact:
      • Taikang Chengguanzhen, Henan, China
        • Recruiting
        • Taikang County People's Hospital
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Henan Sanbo Brain Hospital
        • Contact:
    • Hubei
      • Shiyan, Hubei, China
        • Recruiting
        • Taihe Hospital of Shiyan
        • Contact:
    • Hunan
      • Guankou, Hunan, China
        • Recruiting
        • Liuyang Jili Hospital
        • Contact:
      • Shaodong, Hunan, China
        • Recruiting
        • Shaodong People's Hospital
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • Baotou Central Hospital
        • Contact:
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • People's Hospital of Inner Mongolia Autonomous Region
        • Contact:
      • Ordos, Inner Mongolia, China
        • Recruiting
        • Ordos Central Hospital
        • Contact:
      • Ulanqab, Inner Mongolia, China
        • Recruiting
        • Ulanqab Central Hospital
        • Contact:
      • Wuyuan, Inner Mongolia, China
        • Recruiting
        • Wuyuan County People's Hospital
        • Contact:
    • Jiangsu
      • Nantong, Jiangsu, China
        • Recruiting
        • Affiliated Hospital of Nantong University
        • Contact:
      • Siyang, Jiangsu, China
        • Recruiting
        • Siyang Kangda Hospital
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • Dalian Lushunkou District Hospital of Traditional Chinese Medicine
        • Contact:
      • Dandong, Liaoning, China
        • Recruiting
        • Kuandian Central Hospital
        • Contact:
      • Yingkou, Liaoning, China
        • Recruiting
        • Yingkou Fangda Hospital
        • Contact:
    • Ningxia
      • Shizuishan, Ningxia, China
        • Recruiting
        • The Fifth People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
    • Shaanxi
      • Xianyang, Shaanxi, China
        • Recruiting
        • Xianyang Hospital of Yan'an University
        • Contact:
    • Shandong
      • Binzhou, Shandong, China
        • Recruiting
        • Binzhou Central Hospital, Shandong Province
        • Contact:
      • Liaocheng, Shandong, China
        • Recruiting
        • Third People's Hospital of Liaocheng City, Shandong Province
        • Contact:
      • Tianfu, Shandong, China
        • Recruiting
        • Weihai Wendeng District People's Hospital
        • Contact:
      • Weihai, Shandong, China
        • Recruiting
        • Weihai Municipal Hospital
        • Contact:
      • Weihai, Shandong, China
        • Recruiting
        • Weihai Municipal Third Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • 451560995@Qq.Com
        • Contact:
          • Chang Yan
          • Phone Number: 13681692190
    • Sichuan
      • Jincheng, Sichuan, China
        • Recruiting
        • Yilong County People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Recruiting
        • Tianjin Huanhu Hospital
        • Contact:
    • Yiyang
      • Hunan, Yiyang, China
        • Recruiting
        • Yiyang Central Hospital
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Second Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Comparator: Minocycline treatment group
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
50 mg per capsule, containing 50mg of Minocycline Hydrochloride
Placebo Comparator: Placebo Comparator: Minocycline placebo-control group
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
50 mg per capsule, containing 0 mg of Minocycline Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS score 0-3
Time Frame: At 90±7 days after randomization
Modified Rankin Scale score
At 90±7 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRS score
Time Frame: At 90±7 days and 180±7 days after randomization
Modified Rankin Scale score
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
NIHSS score
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
Glasgow Coma Scale score
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
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.
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
hs-CRP is examined to evaluate the level of systematic inflammation.
At 72±12 hours and 7±1 days after randomization
Volume of perihematomal edema (PHE)
Time Frame: At 7±1 days after randomization
Volume of perihematomal edema (PHE) on MRI
At 7±1 days after randomization
EQ-5D-5L utility score
Time Frame: At 90±7 days and 180±7 days after randomization
Quality of life assessed by the EQ-5D-5L utility score
At 90±7 days and 180±7 days after randomization
Recurrent stroke
Time Frame: At 90±7 days and 180±7 days after randomization
Recurrent stroke includes ischemic stroke and hemorrhagic stroke.
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
Combined vascular events include stroke, myocardial infarction, and vascular death.
At 90±7 days and 180±7 days after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the levels of venous neuroinflammation indicators compared with baseline levels
Time Frame: At 72±12 hours and 7±1 days after randomization
Venous neuroinflammation indicators (IL, TNF-α, TGF-β, NFL, etc.)
At 72±12 hours and 7±1 days after randomization
Perihematomal blood-brain barrier permeability
Time Frame: At 7±1 days after randomization
Perihematomal blood-brain barrier permeability is assessed using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
At 7±1 days after randomization
Hematoma expansion or rebleeding
Time Frame: At 72±12 hours and 7±1 days after randomization
Hematoma expansion or rebleeding
At 72±12 hours and 7±1 days after randomization
Antibiotic-associated diarrhea, enteritis, and constipation
Time Frame: At 7±1 days after randomization
Antibiotic-associated diarrhea, enteritis, and constipation
At 7±1 days after randomization
Any bleeding events
Time Frame: At 90±7 days after randomization
Any bleeding events
At 90±7 days after randomization
Adverse events (AE)
Time Frame: At 90±7 days after randomization
Adverse events (AE)
At 90±7 days after randomization
Serious adverse events (SAE)
Time Frame: At 90±7 days after randomization
Serious adverse events (SAE)
At 90±7 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISTICH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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