A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
- Conditions
- Cerebrovascular Accident
- Registration Number
- NCT00044070
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study will investigate the effects of a potential neuroprotectant compound, YM872, in the treatment of acute ischemic stroke. The study will determine if a 24-hour infusion of YM872, given within 6 hours of stroke onset, reduces the ischemic lesion volume as measured by MRI at 28 days after the infusion is given. The clinical effects of YM872 will also be determined by neurological function and disability scores at follow up visits through Day 90 of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- Patients who have suffered an acute ischemic stroke and can be evaluated and treatment initiated within 6 hours after the onset of symptoms (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
- Patients who have a three dimensionally measurable lesion compatible with an acute ischemic stroke measured using MRI.
- Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
- Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
- Patients who are at least 18 years of age.
- Other criteria as specified in the study protocol
- Patients who have received alteplase (t-PA) for the current stroke episode. It is assumed that all patients who are eligible will receive treatment with t-PA.
- Patients who have disability and functional limitations prior to the current stroke episode (e.g. deficit resulting from a prior stroke).
- Patients who have brain hemorrhage.
- Patients who have stroke of the brainstem or cerebellum.
- Patients who cannot be evaluated using MRI due to the presence of a pacemaker, claustrophobia, need for sedation, etc.
- Patients who have renal (kidney) disease or insufficiency.
- Patients who have active epilepsy or convulsions during the current stroke episode.
- Patients who are IV drug users or are inebriated.
- Patients who have a history of drug-related anaphylaxis.
- Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
- Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
- Patients who have a known vitamin hypersensitivity.
- Other exclusion criteria as specified by the study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (89)
Holmes Regional Medical Center
🇺🇸Melbourne, Florida, United States
Johns Hopkins Medical Institute
🇺🇸Baltimore, Maryland, United States
University of Pittsburgh Medical Center Stroke Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
St. Elizabeth Health Center
🇺🇸Youngstown, Ohio, United States
University of South Alabama Stroke Center
🇺🇸Mobile, Alabama, United States
Providence St. Joseph's Medical Center
🇺🇸Burbank, California, United States
Grossmont Hospital
🇺🇸La Mesa, California, United States
UCLA Emergency Medical Center
🇺🇸Los Angeles, California, United States
Santa Monica UCLA Medical Center
🇺🇸Santa Monica, California, United States
Good Samaritan Hospital
🇺🇸San Jose, California, United States
John Muir Medical Center
🇺🇸Walnut Creek, California, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
Bethesda Memorial Hospital
🇺🇸Boynton Beach, Florida, United States
University of Miami (Jackson Memorial Hospital)
🇺🇸Miami, Florida, United States
Florida Neurovascular Institute
🇺🇸Tampa, Florida, United States
DNA Research (Dekalb Medical Center)
🇺🇸Decatur, Georgia, United States
Parkview Hospital
🇺🇸Fort Wayne, Indiana, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Louisville Neuroscience Research Center
🇺🇸Louisville, Kentucky, United States
New England Medical Center
🇺🇸Boston, Massachusetts, United States
Cullicchia Neurology Clinic, LLP
🇺🇸Marrero, Louisiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Michigan State University
🇺🇸East Lansing, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Advanced Neurology Specialists (Benefis Healthcare Hospital)
🇺🇸Great Falls, Montana, United States
Field Neurosciences Institute (St. Mary's Hospital)
🇺🇸Saginaw, Michigan, United States
St. Patrick's Hospital & Health Sciences Center
🇺🇸Missoula, Montana, United States
Washoe Comprehensive Stroke Center
🇺🇸Reno, Nevada, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States
Neurology Group of Bergen County (Valley Hospital)
🇺🇸Ridgewood, New Jersey, United States
University of New Mexico Hospital
🇺🇸Albuquerque, New Mexico, United States
VA Medical Center
🇺🇸Albuquerque, New Mexico, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
St. Luke's Hospital
🇺🇸New York, New York, United States
Ellis Hospital
🇺🇸Schenectady, New York, United States
All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
🇺🇸Winston-Salem, North Carolina, United States
Stony Brook Hospital
🇺🇸Stony Brook, New York, United States
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Medical College of Ohio
🇺🇸Toledo, Ohio, United States
Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Chattanooga Neurology Associates (Erlanger Hospital)
🇺🇸Chattanooga, Tennessee, United States
Chattanooga Neurology Associates (Memorial Hospital)
🇺🇸Chattanooga, Tennessee, United States
Neurology Associates, Inc. (St. Mary's Hospital)
🇺🇸Richmond, Virginia, United States
University of Texas (Houston Medical Center)
🇺🇸Houston, Texas, United States
Virginia Beach General Hospital
🇺🇸Virginia Beach, Virginia, United States
Stevens Memorial Hospital
🇺🇸Edmonds, Washington, United States
Providence St. Peter Hospital
🇺🇸Olympia, Washington, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Theda Clark Medical Center
🇺🇸Neenah, Wisconsin, United States
Universitätsklinik Allgemeines
🇦🇹Wien, Austria
Hopital Erasme
🇧🇪Brussels, Belgium
Service de Neurologie, Cliniques Universitaires St.-Luc
🇧🇪Bruxelles, Belgium
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Universitätsklinikum Aachen, Neurologische Klinik
🇩🇪Aachen, Germany
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Essen
🇩🇪Essen, Germany
Neurologische Universitätsklinik, Albert-Ludwigs-University
🇩🇪Freiburg, Germany
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
🇩🇪Hamburg-Eppendorf, Germany
Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
🇩🇪Homburg Saar, Germany
Friedrich-Schiller-University
🇩🇪Jena, Germany
Universität zu Köln klinik und poliklinik fur neurology
🇩🇪Koln, Germany
Universitatklinikum Leipzig
🇩🇪Leipzig, Germany
Universitätsklinik Mainz
🇩🇪Mainz, Germany
Department of Neurology Klinikum
🇩🇪Minden, Germany
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
🇩🇪Munchen, Germany
Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
🇩🇪Wiesbaden, Germany
Muelmed Hospital
🇿🇦Arcadia, South Africa
St. Augustine's Hospital
🇿🇦Durban, South Africa
Groote Schuur Hospital
🇿🇦Cape Town, South Africa
Bloemfontein Medi-Clinic
🇿🇦Bloemfontein, South Africa
Sandton Medi-Clinic
🇿🇦Johannesburg, South Africa
Pietermaritzburg Medi-Clinic
🇿🇦Pietermaritzburg, South Africa
Little Company of Mary Medical Centre
🇿🇦Pretoria, South Africa
Vergelegen Medi-Clinic
🇿🇦Somerset West, South Africa
Sunninghill Hospital
🇿🇦Sunninghill, South Africa
Phoenix Neurology Associates (Good Samaritan Hospital)
🇺🇸Phoenix, Arizona, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Neurologische Klinik Knappschafts - krankenhause
🇩🇪Recklinghausen, Germany
Dienst Neurologie UZ Gasthuisberg
🇧🇪Leuven, Belgium
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
University of Arizona
🇺🇸Tucson, Arizona, United States