A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
A Multicenter, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Neurologic Function and Disability in Patients With Acute Ischemic Stroke Given Tissue Plasminogen Activator Plus YM872 or Tissue Plasminogen Activator Plus Placebo
1 other identifier
interventional
N/A
5 countries
118
Brief Summary
The purpose of this study is to determine if YM872 in combination with t-PA can reduce disability and brain damage from stroke. YM872 or placebo will be given as a continuous intravenous (iv) infusion for 24 hours. It is important that the study medication, YM872 or placebo, is administered prior to the completion of the t-PA administration. The clinical effects of YM872 in addition to t-PA will be determined by assessing neurological function and disability scores at follow up visits through Day 90 of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2000
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedFirst Submitted
Initial submission to the registry
August 16, 2002
CompletedFirst Posted
Study publicly available on registry
August 20, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedApril 3, 2006
March 1, 2006
August 16, 2002
March 31, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (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 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.
- 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.
- Other criteria as specified in the study protocol
You may not qualify if:
- Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
- Patients who have stroke of the brainstem or cerebellum.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (118)
University of South Alabama Stroke Center
Mobile, Alabama, United States
Good Samaritan Hospital
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
East Bay Region Associates in Neurology
Berkeley, California, United States
Providence St. Joseph's Medical Center
Burbank, California, United States
Mercy San Juan Hospital
Carmichael, California, United States
University of California Davis Medical Center
Davis, California, United States
Scripps Memorial Hospital
Encinitas, California, United States
Grossmont Hospital
La Mesa, California, United States
UCLA Medical Center
Los Angeles, California, United States
Tri-City Medical Center
Oceanside, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Mercy General Hospital
Sacramento, California, United States
Scripps Mercy Hospital
San Diego, California, United States
University of California at San Diego
San Diego, California, United States
Good Samaritan Hospital
San Jose, California, United States
UCLA Medical Center - Santa Monica
Santa Monica, California, United States
John Muir Medical Center
Walnut Creek, California, United States
Mt Diablo Medical Center
Walnut Creek, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Columbia JFK Hospital
Atlantis, Florida, United States
Bethesda Memorial Hospital
Boynton Beach, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Bay Medical Center
Panama City, Florida, United States
St Joseph's Hospital
Tampa, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St Francis Hospital
Columbus, Georgia, United States
DNA Research (Dekalb Medical Center)
Decatur, Georgia, United States
Candler Hospital
Savannah, Georgia, United States
St Joseph Hospital
Savannah, Georgia, United States
Queen's Medical Center
Honolulu, Hawaii, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Parkview Hospital
Fort Wayne, Indiana, United States
Methodist Hospital
Indianapolis, Indiana, United States
Louisville Neuroscience Research Center
Louisville, Kentucky, United States
Culicchia Neurology Clinic, LLP
Marrero, Louisiana, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
New England Medical Center
Boston, Massachusetts, United States
St John's Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
Bi-County Hospital
Warren, Michigan, United States
Research Medical Center
Kansas City, Missouri, United States
Advanced Neurology Specialists (Benefis Healthcare Hospital)
Great Falls, Montana, United States
Washoe Comprehensive Stroke Center
Reno, Nevada, United States
JFK Medical Center
Edison, New Jersey, United States
Muhlenberg Regional Medical Center
Plainfield, 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
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Roosevelt Hospital
New York, New York, United States
St. Luke's Hospital
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Ellis Hospital
Schenectady, New York, United States
Stony Brook Hospital
Stony Brook, New York, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Rowan Regional Medical Center
Winston-Salem, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Medical College of Ohio
Toledo, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Stroke Institute
Pittsburgh, Pennsylvania, United States
Crozer Chester Medical Center
Upland, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Roper Hospital
Charleston, South Carolina, United States
Chattanooga Neurology Associates (Erlanger Hospital)
Chattanooga, Tennessee, United States
Chattanooga Neurology Associates (Memorial Hospital)
Chattanooga, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas (Houston Medical Center)
Houston, Texas, United States
Neurological Research Center, Inc
Bennington, Vermont, United States
Neurology Associates, Inc. (St. Mary's Hospital)
Richmond, Virginia, 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
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Theda Clark Medical Center
Neenah, Wisconsin, United States
Universitätsklinik allgemeines Krankenhaus der Stadt Wien
Vienna, Austria
Dienst Neurologie UZ Gasthuisberg
Leuven, Belgium
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Penticton Regional Hospital
Penticton, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
Charles LeMoyne Hospital
Greenfield Park, Quebec, Canada
Notre-Dame Hospital
Montreal, Quebec, Canada
Pavillion St Joseph
Trois Rivers, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Universitätsklinikum Aachen, Neurologische Klinik
Aachen, Germany
Universität zu Köln klinik und poliklinik fur neurology
Cologne, Germany
University Essen
Essen, Germany
Neurologische Universitätsklinik
Freiburg im Breisgau, Germany
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
Hamburg-Eppendorf, Germany
Neurology Klinik Klinikum Hanover
Hanover, Germany
Friedrich-Schiller-University
Jena, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinik Mainz
Mainz, Germany
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
München, Germany
Neurologische Klinik Knappschafts - krankenhause
Recklinghausen, Germany
Neurologisch Psychiayrische Klinik
Weisbaden, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 16, 2002
First Posted
August 20, 2002
Study Start
December 1, 2000
Study Completion
January 1, 2003
Last Updated
April 3, 2006
Record last verified: 2006-03