Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL)

Официальное название

Safety and Efficacy of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment

Обзор

This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies.

Подробное описание

This study is an investigator-initiated, prospective, multicenter Phase Ib clinical trial designed to evaluate the safety, tolerability, and dose feasibility of anisodine hydrobromide administered in patients with acute ischemic stroke undergoing endovascular therapy. The trial adopts an open-label, non-randomized, dose-escalation design to identify the maximum tolerated dose (MTD) and to determine the recommended Phase II dose (RP2D).

Вмешательства

• Препарат Anisodine Hydrobromide
  Anisodine hydrobromide injection is administered intravenously in addition to standard endovascular therapy for acute ischemic stroke. The investigational drug is diluted in 250 mL of 0.9% sodium chloride solution and infused over approximately 60 minutes. Treatment is given twice daily (BID) for 7 consecutive days, with the first dose initiated prior to vascular recanalization. In this Phase Ib study, four dose levels (1.0 mg, 1.5 mg, 2.0 mg, and 2.5 mg per dose) are evaluated using a sequenti

Первичные конечные точки

• Incidence of Predefined Safety Events [Срок оценки: Within 8 days after the first administration]

Вторичные конечные точки (6)

• Early Neurological Deterioration [Срок оценки: Within 24 hours after treatment initiation]
• Infarct Volume [Срок оценки: Day 8]
• Functional Outcome (Modified Rankin Scale) [Срок оценки: Day 90]
• Symptomatic Intracranial Hemorrhage [Срок оценки: Within 8 days after the first administration]
• Intracranial Hemorrhage [Срок оценки: Within 8 days after the first administration]
• All-cause Mortality [Срок оценки: Within 90 days after the first administration]

Критерии участия

Критерии включения

• Age 18 to 80 years.
• Imaging-confirmed anterior-circulation large-vessel occlusion involving the intracranial internal carotid artery, the middle cerebral artery M1 segment, or the proximal M2 segment or a dominant M2 branch. A dominant M2 branch was defined as an M2 branch supplying ≥50% of the middle cerebral artery territory.
• Eligible for and planned to undergo endovascular treatment (EVT) within 24 hours according to current clinical practice.
• National Institutes of Health Stroke Scale (NIHSS) score ≥6 at baseline.
• Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline noncontrast CT.
• Pre-stroke modified Rankin Scale (mRS) score of 0 to 1.
• Provision of written informed consent by the participant or the participant's legally authorized representative.

Критерии исключения

• Evidence of intracranial hemorrhagic disease on head CT, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage.
• History of congenital or acquired bleeding disorders, coagulation factor deficiency, thrombocytopenic disorders, or other clinically significant hemorrhagic conditions.
• Vascular anatomy expected to preclude successful endovascular treatment because of excessive tortuosity or other technical reasons.
• Known allergy to iodinated contrast agents.
• Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 90 days after enrollment.
• Known hypersensitivity to anisodine hydrobromide or a history of severe intolerance after prior exposure.
• Presence of clinical conditions that may be worsened by anticholinergic drugs, including but not limited to angle-closure glaucoma, urinary retention or benign prostatic hyperplasia with dysuria, or paralytic ileus.
• Severe arrhythmia or hemodynamic instability, including but not limited to tachyarrhythmia requiring cardioversion, recurrent syncope due to arrhythmia, vasopressor-dependent hypotension, or persistent hypotension.
• Severe psychiatric disorder, dementia, or impaired consciousness that would preclude informed consent or protocol-required follow-up.
• Malignant tumor or other severe systemic disease with an expected survival of less than 90 days.
• Participation in another interventional clinical study within 30 days before enrollment, or current participation in another interventional clinical study.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 10 центров

• Zhangpu County Hospital — Zhangzhou
• Jiuquan City People's Hospital — Jiuquan
• The Second People's Hospital of Yulin — Yulin
• The First People's Hospital of Shangqiu — Shangqiu
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou
• Xuanwu Hospital, Capital Medical University — Пекин
• Zibo Central Hospital — Zibo
• Anji County People's Hospital — Huzhou
• … и ещё 2 центра

Идентификаторы

NCT: NCT07513233 · HEAL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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