Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage: a Multicenter, Randomized, Open-label, Blinded Endpoint Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,248
- 主要终点
- The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Minocycline (Drug)
结局指标
主要结局
The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days.
时间窗: 180 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
次要结局
- 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)