Optimizing Reperfusion to Improve Outcomes and Neurologic Function

Официальное название

Optimizing Reperfusion to Improve Outcomes and Neurologic Function (ORION): A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of JX10 in Acute Ischemic Stroke With Late Presentations

Обзор

The goal of this study is to evaluate the safety and efficacy of JX10 versus placebo in participants with Acute Ischemic Stroke (AIS) who present for care within 4.5 to 24 hours. The main question the study aims to answer are: 1. JX10 improves functional outcomes as measured by the modified Rankin Scale score when compared with placebo following AIS. 2. Risk of symptomatic intracranial hemorrhage of JX10 in participants with AIS. During Part 1, participants will be randomized to JX 10 (1mg/kg, 3 mg/kg) or placebo. During Part 2, participants will receive JX10 (optimal dose chosen from Part 1) or placebo.

Вмешательства

• Препарат JX10
  JX10 is a thrombolytic agent.
• Препарат Placebo
  Placebo is being used as the comparator.

Первичные конечные точки

• Efficacy: Proportion of participants with no or minimal symptoms (mRS score 0-1) at 90 days [Срок оценки: 90 days]
• Safety: Incidence of symptomatic intracranial hemorrhage within 36 hours post-randomization [Срок оценки: Within 36 hours post-randomization]

Вторичные конечные точки (4)

• Ordinal mRS score (0-6), based on a 6-point ordinal scale at 90 days [Срок оценки: 90 days]
• Proportion of participants with functional independence at 90 days [Срок оценки: 90 days]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: 90 days]
• Incidence of major bleeding within 24 hours and 14 days of study treatment [Срок оценки: Within 24 hours and 14 days of study treatment]

Критерии участия

Критерии включения

• Age ≥ 18 and ≤ 90 years old.
• Acute ischemic stroke with compatible clinical presentation and symptomatic high grade or complete occlusion of the intracranial internal carotid, M1, M2 or distal branches of the middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA).
• Radiographic evidence of salvageable tissue.
• Pre-treatment score of NIHSS ≥ 5.

Критерии исключения

• Radiographic findings pre-randomization of any of the following:

• Large core infarction, or
• Occlusion in more than 1 vascular territory, or
• Significant mass effect or clinically significant cerebral edema, or
• Evidence of acute intracranial or extracranial hemorrhage, intracranial tumor (except small meningioma), neoplasm, or arteriovenous malformation), or
• Clinical history, past imaging, or clinical judgement suggests that the intracranial occlusion is chronic.
• Medical history or active clinically significant bleeding, lesions, or conditions (at the investigator's judgement) considered to be of significant risk for major bleeding.
• Severe, uncontrolled hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that cannot be controlled with antihypertensive therapy.
• Known bleeding diathesis (hereditary or acquired) or any significant coagulopathy. Specifically, platelet count < 100,000/μL, international normalized ratio > 1.7, aPTT > 40 seconds, or prothrombin time > 15 seconds.
• Major trauma, surgery, or invasive procedures.
• Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluations of this study.
• Pre-treatment blood glucose > 400 mg/dL (22.20 mmol/L) or Pre-treatment blood glucose < 50 mg/dL (2.78 mmol/L) unless it is corrected prior to study treatment administration. Participants with subsequently normalized blood glucose levels may be considered for inclusion, per Investigator judgement.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 17 центров

• Corxel Investigational Site — Long Beach
• Corxel Investigational Site — Sacramento
• Corxel Investigational Site — Colorado Springs
• Corxel Investigational Site — Washington D.C.
• Corxel Investigational Site — Delray Beach
• Corxel Investigational Site — Chicago
• Corxel Investigational Site — Wichita
• Corxel Investigational Site — Baltimore
• … и ещё 9 центров

Китай · 14 центров

• Corxel Investigational Site — Baotou
• Corxel Investigational Site — Пекин
• Corxel Investigational Site — Пекин
• Corxel Investigational Site — Changchun
• Corxel Investigational Site — Гуанчжоу
• Corxel Investigational Site, — Харбин
• Corxel Investigational Site — Харбин
• Corxel Investigational Site — Kaili
• … и ещё 6 центров

Япония · 10 центров

• Corxel Investigational Site — Fukuoka
• Corxel Investigational Site — Hyōgo
• Corxel Investigational site — Ibaraki
• Corxel Investigational Site — Kamakura
• Corxel Investigational Site — Meguro City
• Corxel Investigational Site — Mitaka
• Corxel Investigational Site — Miyagi
• Corxel Investigational site — Toyota
• … и ещё 2 центра

Испания · 8 центров

• Corxel Investigational Site — A Coruña
• Corxel Investigational Site — Albacete
• Corxel Investigational Site — Barcelona
• Corxel Investigational Site — Girona
• Corxel Investigational Site — Madrid
• Corxel Investigational Site — Málaga
• Corxel Investigational Site — Seville
• … и ещё 1 центр

Болгария · 5 центров

• Corxel Investigational Site — Blagoevgrad
• Corxel Investigational Site — Burgas
• Corxel Investigational Site — Pleven
• Corxel Investigational Site — Plovdiv
• Corxel Investigational Site — Sofia

Германия · 4 центра

• Corxel Investigational Site — Altenburg
• Corxel Investigational Site — Leipzig
• Corxel Investigational Site — Lübeck
• Corxel Investigational Site — Trier

Греция · 4 центра

• Corxel Investigational Site — Athens
• Corxel Investigational Site — Chaïdári
• Corxel Investigational Site — Pátrai
• Corxel Investigational Site — Thessaloniki

Сербия · 4 центра

• Corxel Investigational Site — Belgrade
• Corxel Investigational Site — Kragujevac
• Corxel Investigational Site — Niš
• Corxel Investigational Site — Novi Sad

Канада · 2 центра

• Corxel Investigational Site — Edmonton
• Corxel Investigational Site — Kingston

Франция · 2 центра

• Corxel Investigational site — Lille
• Corxel Investigational site — Paris

Италия · 2 центра

• Corxel Investigational Site — Pavia
• Corxel Investigational Site — Roma

Латвия · 2 центра

• Corxel Investigational Site — Daugavpils
• Corxel Investigational Site — Riga

Литва · 2 центра

• Corxel Investigational Site — Kaunas
• Corxel Investigational Site — Vilnius

Португалия · 2 центра

• Corxel Investigational Site — Braga
• Corxel Investigational Site — Loures

Таиланд · 2 центра

Список центров уточняется — проверьте первичный протокол.

Бельгия · 1 центр

• Corxel Investigational Site — Ghent

Малайзия · 1 центр

• Corxel Investigational Site — Kuching

South Korea · 1 центр

• Corxel Investigational Site — Seoul

Идентификаторы

NCT: NCT06990867 · JX10002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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