PHASE 2, MULTICENTER, OPEN-LABEL, TWO-STAGE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRA-ARTERIAL CATHETER-DIRECTED ALFIMEPRASE FOR RESTORATION OF NEUROLOGIC FUNCTION AND RAPID OPENING OF ARTERIES IN STROKE (CARNEROS-1) - CARNEROS-1

• Conditions: Acute Ischemic Stroke (AIS); MedDRA version: 9.1Level: LLTClassification code 10055221Term: Ischemic stroke

• Registration Number: EUCTR2007-005254-24-AT
• Lead Sponsor: uvelo, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

Subjects who meet all of the following criteria will be eligible for this study:
a. Clinical diagnosis of AIS defined as the sudden onset of an acute focal neurological deficit presumed to be due to cerebral ischemia
b. Arterial occlusion of the carotid T or a M1, M2, or M1-M2 branch of the middle cerebral artery (MCA) as documented by CT angiography or magnetic resonance angiography
c. Arteriographically confirmed occlusion of the carotid T or a M1, M2, or M1-M2 branch of the MCA
d. The subject (or legally acceptable representative) must give written informed consent
e. Age 18 years to 85 years
f. Onset of symptoms of AIS (i.e., last known well time) within 3-9 hours
g. Baseline NIHSS of 4 to 25
h. Available for follow-up assessments at 30 and 90 days

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

Subjects who meet any of the following criteria are not eligible for the study.
a. Contraindication to systemic anticoagulation, e.g., history of documented hemorrhage requiring treatment within the past 30 days; history of a hereditary bleeding disorder or known bleeding diathesis; major surgery or trauma, open chest massage, ocular surgery or hemorrhagic retinopathy within the past 30 days; puncture at non-compressible site within 48 hours prior to administration of study drug; history of stroke (excluding the index event), unstable central nervous system structural abnormalities (e.g., arteriovenous malformation or brain tumor) within the past 3 months, and any history of prior intracranial hemorrhage
b. Uncontrolled hypertension at study entry as defined by systolic blood pressure (SBP) greater than 180 mmHg or diastolic blood pressure (DBP) greater than or equal to 100 mmHg on repeated measures prior to study entry despite the use of IV antihypertensive agents
c. Expectation based on timing of presentation that alfimeprase administration will not be able to be completed by 9 hours after stroke onset
d. Inability to initiate alfimeprase dosing within 120 minutes of the qualifying imaging scan
e. Coma
f. Rapidly improving neurological symptoms at the time of screening
g. Brain CT or MRI evidence of intracranial bleeding of any age
h. High clinical suspicion for subarachnoid hemorrhage despite a negative baseline CT or MRI
i. CT evidence of an acute and/or evolving hypodensity greater than 1/3 of the MCA territory in the vascular territory to be treated or Alberta Stroke Program Early CT Score (ASPECTS) of less than or equal to 5
j. MRI diffusion weighted imaging lesion greater than 1/3 of the MCA territory in the vascular distribution to be treated
k. Carotid artery and/or intracranial artery stenosis that precludes safe passage of a microcatheter to treat the primary AOL
l. Life expectancy of less than 6 months (e.g., terminal cancer)
m. History of significant acute or chronic kidney disease, including known nephrotic syndrome, that would preclude safe contrast angiography
n. Known allergy to contrast agents
o. History of immune deficiency
p. History of heparin-induced thrombocytopenia (HIT)
q. Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to enrollment (Stage I) / randomization (Stage II)
r. Any stroke, myocardial infarction, or use of thrombolytic therapy (including investigational thrombolytic therapy) within 3 months prior to enrollment (Stage I) / randomization (Stage II)
s. Past participation in any alfimeprase clinical trial
t. Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g., intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
u. Current use of oral anticoagulants or an international normalized ratio (INR) greater than 1.4
v. Any non-atherosclerotic arteriopathy (e.g., vasculitis)
w. Any prior neurologic event that would obscure the radiographic or clinical evaluation of the new index neurologic deficits
x. Subjects with known renal insufficiency defined as a serum creatinine > 2 mg/dL (> 180 µmol/L)
y. Subjects with known clinically significant hepatic disease defined as transaminase values > 3x ULN
z. Subjects with any malignant neoplasm diagnosed within five years prior to screening, with t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified