Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

Jilin University

Status: Not yet enrolling

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT07305896

Enhance

Details and patient eligibility

About

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.

Enrollment: 1,248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, use of thrombolytic drugs;
2. Allergy to tetracycline antibiotics;
3. Use of vitamin A derivatives or steroid therapy within the past 3 months;
4. Concomitant infection requiring antibiotic treatment at admission;
5. Planned surgical intervention;
6. Life expectancy of less than 6 months due to comorbid conditions;
7. 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);
8. 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;
9. Known pregnancy or breastfeeding;
10. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
11. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen;
12. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,248 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Minocycline

Control group

No Intervention group

Description:

The control group will only receive medical therapy after randomization.