Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

NCT07305896 | Not Yet Recruiting DMC

• 1 other identifier: Enhance
• Study Type: interventional
• Target: 1,248
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

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

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

  180 days

Secondary Outcomes (5)

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

  180 days

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

  90 days

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

  90 days

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

  90 days and 180 days

• The NIHSS scores after 7 days of treatment.

  7 days

Other Outcomes (4)

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

  180 days

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

  180 days

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

  180 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Drug: Minocycline

Control group

NO INTERVENTION

The control group will only receive medical therapy after randomization.

Interventions

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.

Experimental group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Cerebral Hemorrhage

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

Yi Yang, Pro

CONTACT

88782378; doctoryangyi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 26, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12