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NCT Number: NCT07305896

Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

This study plans to enroll 1248 patients with supratentorial ICH within 24 hours of onset across multiple stroke centers. After randomization, the control group will only receive medical therapy. The experimental group, after randomization, will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical ttherapy, followed by 100 mg orally every 12 hours for 7 days, resulting in a total of 14 administrations. Both groups will be followed for 180 days to evaluate the efficacy and safety of minocycline in the treatment of ICH.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years, regardless of gender;
  • Supratentorial ICH confirmed by brain CT scan;
  • No disability in the community before ICH (premorbid mRS≤1);
  • Neurological deficits related to the hematoma, with NIHSS score ≥ 6 and single-limb motor item score ≥ 2;
  • GCS score ≥ 6;
  • Able to initiate the first dose of minocycline within 24 hours of onset;
  • Signed and dated informed consent.

Exclusion criteria

  • Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, use of thrombolytic drugs;
  • Allergy to tetracycline antibiotics;
  • Use of vitamin A derivatives or steroid therapy within the past 3 months;
  • Concomitant infection requiring antibiotic treatment at admission;
  • Planned surgical intervention;
  • Life expectancy of less than 6 months due to comorbid conditions;
  • Severe hepatic and renal dysfunction, or AST and/or ALT >3 times the upper limit of reference range, or serum creatinine >265 μmol/L (> 3 mg/dL);
  • Bleeding tendency, including heparin use within the past 48 hours (APTT ≥ 35 s), oral warfarin (INR > 2), platelet count < 100 × 10⁹/L, or hereditary hemorrhagic diseases;
  • Known pregnancy or breastfeeding;
  • Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
  • A high likelihood that the patient will not adhere to the study treatment and follow-up regimen;
  • Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

Treatment and study plan

Minocycline

Drug

The experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations.

Primary outcomes

  1. The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days.

    Time frame: 180 days

    Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Secondary outcomes

  1. The proportion of patients with an mRS score of 0-1 at 180 days.

    Time frame: 180 days

    Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

  2. The proportion of patients with favorable functional outcome (mRS score of 0-2) at 90 days.

    Time frame: 90 days

    Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

  3. The proportion of patients with an mRS score of 0-1 at 90 days.

    Time frame: 90 days

    Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

  4. The distribution of mRS scores at 90 days and 180 days.

    Time frame: 90 days and 180 days

    Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

  5. The NIHSS scores after 7 days of treatment.

    Time frame: 7 days

    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

Other outcomes

  1. The incidence of any adverse events during the study period.

    Time frame: 180 days

    Adverse events.

  2. The incidence of serious adverse events during the study period.

    Time frame: 180 days

    Serious adverse events.

  3. The incidence of minocycline-related adverse events during the study period.

    Time frame: 180 days

    Minocycline-related adverse events.

  4. Mortality during the study period.

    Time frame: 180 days

    Mortality.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, Pro

CONTACT

[email protected]

88782378 ext. 0431

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage: a Multicenter, Randomized, Open-label, Blinded Endpoint Clinical Study

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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