Phase 2 Proof-of-Concept Study of the Safety and Efficacy of Alfimeprase to Rapidly Open Arteries and Restore Brain Function Following a Stroke

Stopped early · Phase 2

Conditions studied: Acute Ischemic Stroke

In brief

The purpose of this study is to identify a safe and effective bolus dose of intra-arterial/intra-thrombus alfimeprase in acute ischemic stroke (AIS) 3 to 9 hours from symptom onset.

Key facts

Study ID

NCT00499902

Run by

ARCA Biopharma, Inc.

People needed

7

Starts

2007-06-01

Expected to finish

2008-05-01

Last updated by the study team

2008-04-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of AIS defined as the sudden onset of an acute focal neurological deficit presumed to be due to cerebral ischemia
• 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

You may not qualify if…

• Contraindication to systemic anticoagulation including any history of prior intracranial hemorrhage
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.