Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• The proportion of patients with an mRS score of 0-1 at 180 days. [Срок оценки: 180 days]
• The proportion of patients with favorable functional outcome (mRS score of 0-2) at 90 days. [Срок оценки: 90 days]
• The proportion of patients with an mRS score of 0-1 at 90 days. [Срок оценки: 90 days]
• The distribution of mRS scores at 90 days and 180 days. [Срок оценки: 90 days and 180 days]
• The NIHSS scores after 7 days of treatment. [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07305896 · Enhance

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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