EUCTR2008-006444-19-SK进行中（未招募）1 期
AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All of the following inclusion criteria need to be fulfilled:
- •· Diagnosis of acute ischemic stroke with an onset within 9 hours prior to
- •start of study agent administration.
- •· ischemic stroke in the MCA territory confirmed by MRI (diffusion)
- •· men and women aged = 18 years and = 85 years
- •· NIHSS score = 6 and =22
- •· lesion size on DWI: on the slice showing the largest extension of the
- •infarct the largest diameter of the lesion should have at least 3 cm and
- •should show on at least 3 consecutive slices; if the rule cannot be
- •applied (e.g. due to an irregular shape or partially separate volumes on
- •the slice), but in the clinical judgment the lesion is = 15 cm3, the patient
- •should be included in the clinical study if the investigator can provide a
- •written justification
- •· written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria will be excluded from randomization:
- •· Participation in another study with an investigational drug or device within
- •the last 30 days or planned participation in another trial
- •· Prior to current stroke: Inability to walk or to lead an independent life or prestroke
- •BI score < 95 or pre-stroke mRS score > 1
- •· Life expectancy considered to be less or equal 6 months in the judgment
- •of the investigator
- •· Neurological deficit that has led to stupor or coma (suspicious of
- •malignant hemispheric stroke)
- •· Infarct is lacunar
- •· Any evidence of ICH by imaging. Patients with cerebral micro-bleedings can be included in the study.
- •· Current malignant hypertension with systolic and diastolic blood pressure
- •> 220 mmHg and > 120 mmHg, respectively
- •· Strong clinical suspicion of septic embolus
- •· Any thrombosis involving the cerebral veins
- •· High clinical suspicion of vasculitis (e.g. multiple caliber irregularities of
- •intracerebral vessels on MRA plus history of vasculitis)
- •· Any MRI finding indicating that there might be a non-vascular cause for
- •the present neurological symptoms
- •· Any signs on imaging of a mass effect causing shift of midline structures
- •· Presence or history of active malignancies within one year preceding
- •randomization, especially
- •hematological malignancies or
- •myeloproliferative diseases
- •· A platelet count < 100 /nl at V0
- •· A leukocyte count >20 /nl at V0
- •· Congenital neutropenia
- •· Other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute
- •myocardial infarction or a complex disease that may confound treatment
- •· Any suspected hypersensitivity and/or contraindication to any ingredients
- •of the study medication
- •· Patients currently receiving G-CSF or GM-CSF
- •· Thrombolytic drug treatment outside the recommendations of the current ESO Guidelines for Management of Ischemic Stroke and Transient Ischemic Attack 200, especially if the treatment was initiated > 4.5 hours after stroke onset, or the patient had recent severe or dangerous bleeding prior treatment, or despite anticoagulant or heparin treatment
- •· Patients for which any of the following treatments are planned for acute recanalisation of intracranial vessels: use of mechanical devices for clot retraction like the Merci Retriever or the Penumbra System, or any vessel dilation or stenting procedure
- •· Pregnant or lactating women (for women of childbearing potential a
- •negative serum pregnancy test is required at V0)
- •· Patients with a history of active substance abuse (including alcohol) for
- •the last 2 years
研究者
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