AXIS 2: AX200 for the treatment of ischemic strokeA multinational, multicenter, randomized, doubleblind,placebo-controlled, phase II trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 328

Inclusion Criteria

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

Exclusion Criteria

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
assessment
· 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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