Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke
NCT ID: NCT00499902
Last Updated: 2008-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2007-06-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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2 stages
This is a two-stage study. The first stage is in a three-tier dose escalation format, followed by a second stage during which subjects will be randomized in an equal proportion to up to 3 qualifying dose arms.
alfimeprase
Alfimeprase will be given as a single bolus of 1mg/2mL, or a split bolus of 5mg/2mL or 10mg/2mL in a three-tier dose escalation format. The 5mg and 10mg doses will be administered as split doses with 1/2 of the total dose given initially and 1/2 of the total dose given 30 minutes after the initial dose.
Interventions
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alfimeprase
Alfimeprase will be given as a single bolus of 1mg/2mL, or a split bolus of 5mg/2mL or 10mg/2mL in a three-tier dose escalation format. The 5mg and 10mg doses will be administered as split doses with 1/2 of the total dose given initially and 1/2 of the total dose given 30 minutes after the initial dose.
Eligibility Criteria
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Inclusion Criteria
* 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
* Arteriographically confirmed occlusion of the carotid T or a M1, M2, or M1-M2 branch of the MCA
* The subject (or legally acceptable representative) must give written informed consent
* Age 18 years to 85 years
* Onset of symptoms of AIS (i.e., last known well time) within 3-9 hours
* Baseline NIHSS of 4 to 25
* Available for follow-up assessments at 30 and 90 days
Exclusion Criteria
* Uncontrolled hypertension at study entry as defined by systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than or equal to 100 mmHg on repeated measures prior to study entry despite the use of IV antihypertensive agents
* Expectation based on timing of presentation that alfimeprase administration will not be able to be completed by 9 hours after stroke onset
* Inability to initiate alfimeprase within 120 minutes of the qualifying imaging scan
* Coma
* Rapidly improving neurological symptoms at the time of screening
* Brain CT or MRI evidence of intracranial bleeding of any age
* High clinical suspicion for subarachnoid hemorrhage despite a negative baseline CT or MRI
* 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
* MRI diffusion weighted imaging lesion greater than 1/3 of the MCA territory in the vascular distribution to be treated
* Carotid artery and/or intracranial artery stenosis that precludes safe passage of a microcatheter to treat the primary AOL
* Life expectancy of less than 6 months
* History of significant acute or chronic kidney disease, including known nephrotic syndrome, that would preclude safe contrast angiography
* Known allergy to contrast agents
* History of immune deficiency
* History of heparin-induced thrombocytopenia
* Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to enrollment (Stage I)/randomization (Stage II)
* Any stroke, myocardial infarction, or use of thrombolytic therapy (including investigational thrombolytic therapy) within 3 months prior to enrollment (Stage I)/randomization (Stage II)
* Past participation in any alfimeprase clinical trial
* Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions
* Current use of oral anticoagulants or an international normalized ratio (INR) greater than 1.4
* Any non-atherosclerotic arteriopathy
* Any prior neurologic event that would obscure the radiographic or clinical evaluation of the new index neurological deficits
* Subjects with known renal insufficiency defined as a serum creatinine \>2 mg/dL (\>180 mmoL/L)
* Subjects with known clinically significant hepatic disease defined as transaminase values \> 3x upper limit of normal
* Subjects with any malignant neoplasm diagnosed within five years prior to screening, with the exception of basal cell carcinoma of the skin and fully resected squamous cell carcinoma of the skin
* Subjects with a platelet count less than 100,000/mm3
* Subjects with a baseline serum glucose level less than 50 mg/dL or greater than 300 mg/dL
* Subjects receiving any dose of a heparinoid or a non-prophylactic intensity dose of a low molecular weight heparin within the 24-hour period prior to study drug administration
* Any other subject feature that in the opinion of the investigator should preclude study participation
18 Years
85 Years
ALL
No
Sponsors
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ARCA Biopharma, Inc.
INDUSTRY
Responsible Party
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Nuvelo, Inc.
Principal Investigators
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Susan M Begelman, MD
Role: STUDY_DIRECTOR
ARCA Biopharma, Inc.
Locations
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UCLA Medical Center
Los Angeles, California, United States
Northwestern Medical Center
Chicago, Illinois, United States
Ruan Neurology & Clinical Research Center
Des Moines, Iowa, United States
University of Iowa Hospital
Iowa City, Iowa, United States
University of Iowa Hospital
Iowa City, Iowa, United States
University of Kansas School of Medicine, Via Christi Regional Medical Center
Wichita, Kansas, United States
Norton Hospital
Louisville, Kentucky, United States
Michigan State University, Sparrow Hospital
Lansing, Michigan, United States
Albany Medical Center Hospital
Albany, New York, United States
Kalieda Health, MFH
Buffalo, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Oregon Stroke Center
Portland, Oregon, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Trilium Health Center
Mississauga, Ontario, Canada
University Health Network Toronto
Toronto, Ontario, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
Countries
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Related Links
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Company Website
Other Identifiers
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HA009
Identifier Type: -
Identifier Source: org_study_id