Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

Официальное название

Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial

Обзор

The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Подробное описание

Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Вмешательства

• Препарат Urinary kallidinogenase for injection
  Urinary kallidinogenase 0.15PNA once daily for 7 days.
• Другое Guideline-prescribed medical therapy
  Guideline-prescribed medical therapy

Первичные конечные точки

• Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days [Срок оценки: 90 days]

Вторичные конечные точки (3)

• National Institute of Health Stroke Scale (NIHSS) at 7days. [Срок оценки: 7days]
• Incidence of ischemic stroke within 90 days. [Срок оценки: 0-90days]
• Adverse events occurring in the course of the treatment. [Срок оценки: 0-7days]

Критерии участия

Критерии включения

• Age ≥18 years old;
• Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
• Moderate to severe stenosis or occlusion of offending vessels;
• The mRS Score ≤2 before onset;
• Subjects or their legal representatives agreed to the treatment and signed the informed consent form.

Критерии исключения

• Transient ischemic attack;
• Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
• Severe disturbance of consciousness:GCS ≤8;
• Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
• Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg;
• Liver dysfunction (ALT/AST >1.5 × upper limit of normal \[ULN\]), renal dysfunction (Cr >1 × ULN);
• Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds);
• Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
• Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons;
• Unwilling to be followed up or poor treatment compliance;
• Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
• Other conditions considered by the investigator to be inappropriate for enrollment.

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

Китай · 1 центр

• First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT06137300 · TK-LAA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗