Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

NCT ID: NCT07305896

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: 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.

Control group

The control group will only receive medical therapy after randomization.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Minocycline

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yi Yang, Pro

Role: CONTACT

Phone: 88782378

Email: doctoryangyi@163.com

Other Identifiers

Enhance

Identifier Type: -

Identifier Source: org_study_id