Back to resultsA Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM872 (zonampanel), t-PA (alteplase)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring ARTIST
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Other exclusion criteria as specified by the study protocol
Sites / Locations
- University of South Alabama Stroke Center
- Good Samaritan Hospital
- University of Arizona
- East Bay Region Associates in Neurology
- Providence St. Joseph's Medical Center
- Mercy San Juan Hospital
- University of California Davis Medical Center
- Scripps Memorial Hospital
- Grossmont Hospital
- UCLA Medical Center
- Tri-City Medical Center
- Stanford University Medical Center
- Mercy General Hospital
- Scripps Mercy Hospital
- University of California at San Diego
- Good Samaritan Hospital
- UCLA Medical Center - Santa Monica
- John Muir Medical Center
- Mt Diablo Medical Center
- Colorado Neurological Institute
- Bridgeport Hospital
- Columbia JFK Hospital
- Bethesda Memorial Hospital
- Lakeland Regional Medical Center
- Holmes Regional Medical Center
- Bay Medical Center
- St Joseph's Hospital
- Tampa General Hospital
- St Francis Hospital
- DNA Research (Dekalb Medical Center)
- Candler Hospital
- St Joseph Hospital
- Queen's Medical Center
- OSF St. Francis Medical Center
- Parkview Hospital
- Methodist Hospital
- Louisville Neuroscience Research Center
- Culicchia Neurology Clinic, LLP
- University of Maryland Medical System
- Beth Israel Deaconess Medical Center
- New England Medical Center
- St John's Hospital
- Michigan State University
- William Beaumont Hospital
- Northern Michigan Neurology
- Bi-County Hospital
- Research Medical Center
- Advanced Neurology Specialists (Benefis Healthcare Hospital)
- Washoe Comprehensive Stroke Center
- JFK Medical Center
- Muhlenberg Regional Medical Center
- Neurology Group of Bergen County (Valley Hospital)
- University of New Mexico Hospital
- VA Medical Center
- Albany Medical Center
- Buffalo General Hospital
- North Shore University Hospital
- Long Island Jewish Medical Center
- Columbia Presbyterian Medical Center
- Roosevelt Hospital
- St. Luke's Hospital
- Rochester General Hospital
- Ellis Hospital
- Stony Brook Hospital
- Forsyth Medical Center
- Rowan Regional Medical Center
- Akron General Medical Center
- Metrohealth Medical Center
- Riverside Methodist Hospital
- Medical College of Ohio
- St. Elizabeth Health Center
- Lehigh Valley Hospital
- Geisinger Medical Center
- Westmoreland Regional Hospital
- Hershey Medical Center
- Albert Einstein Medical Center
- Thomas Jefferson University Hospital
- University of Pennsylvania Medical Center
- University of Pittsburgh Medical Center Stroke Institute
- Crozer Chester Medical Center
- Miriam Hospital
- Roper Hospital
- Chattanooga Neurology Associates (Erlanger Hospital)
- Chattanooga Neurology Associates (Memorial Hospital)
- St. Thomas Hospital
- Vanderbilt University Medical Center
- University of Texas (Houston Medical Center)
- Neurological Research Center, Inc
- Neurology Associates, Inc. (St. Mary's Hospital)
- Virginia Beach General Hospital
- Stevens Memorial Hospital
- Providence St. Peter Hospital
- St. Luke's Medical Center
- Theda Clark Medical Center
- Universitätsklinik allgemeines Krankenhaus der Stadt Wien
- Dienst Neurologie UZ Gasthuisberg
- Foothills Medical Centre
- University of Alberta Hospital
- Penticton Regional Hospital
- Vancouver General Hospital
- Royal Jubilee Hospital
- Victoria General Hospital
- Charles LeMoyne Hospital
- Notre-Dame Hospital
- Pavillion St Joseph
- Royal University Hospital
- Universitätsklinikum Aachen, Neurologische Klinik
- University Essen
- Neurologische Universitätsklinik
- Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
- Neurology Klinik Klinikum Hanover
- Friedrich-Schiller-University
- Universität zu Köln klinik und poliklinik fur neurology
- Universitätsklinikum Leipzig
- Universitätsklinik Mainz
- Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
- Neurologische Klinik Knappschafts - krankenhause
- Neurologisch Psychiayrische Klinik
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00044057
First Posted
August 16, 2002
Last Updated
March 31, 2006
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00044057
Brief Title
A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
ARTIST
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM872 (zonampanel), t-PA (alteplase)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Other exclusion criteria as specified by the study protocol
Facility Information:
Facility Name
University of South Alabama Stroke Center
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Good Samaritan Hospital
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
East Bay Region Associates in Neurology
City
Berkeley
State/Province
California
Country
United States
Facility Name
Providence St. Joseph's Medical Center
City
Burbank
State/Province
California
Country
United States
Facility Name
Mercy San Juan Hospital
City
Carmichael
State/Province
California
Country
United States
Facility Name
University of California Davis Medical Center
City
Davis
State/Province
California
Country
United States
Facility Name
Scripps Memorial Hospital
City
Encinitas
State/Province
California
Country
United States
Facility Name
Grossmont Hospital
City
La Mesa
State/Province
California
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Tri-City Medical Center
City
Oceanside
State/Province
California
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
Country
United States
Facility Name
Scripps Mercy Hospital
City
San Diego
State/Province
California
Country
United States
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
Country
United States
Facility Name
UCLA Medical Center - Santa Monica
City
Santa Monica
State/Province
California
Country
United States
Facility Name
John Muir Medical Center
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Mt Diablo Medical Center
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
Country
United States
Facility Name
Columbia JFK Hospital
City
Atlantis
State/Province
Florida
Country
United States
Facility Name
Bethesda Memorial Hospital
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
Country
United States
Facility Name
Holmes Regional Medical Center
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
Bay Medical Center
City
Panama City
State/Province
Florida
Country
United States
Facility Name
St Joseph's Hospital
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
Country
United States
Facility Name
St Francis Hospital
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
DNA Research (Dekalb Medical Center)
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Candler Hospital
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
St Joseph Hospital
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Queen's Medical Center
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Methodist Hospital
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Louisville Neuroscience Research Center
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Culicchia Neurology Clinic, LLP
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
New England Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
St John's Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
Country
United States
Facility Name
Northern Michigan Neurology
City
Traverse City
State/Province
Michigan
Country
United States
Facility Name
Bi-County Hospital
City
Warren
State/Province
Michigan
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Advanced Neurology Specialists (Benefis Healthcare Hospital)
City
Great Falls
State/Province
Montana
Country
United States
Facility Name
Washoe Comprehensive Stroke Center
City
Reno
State/Province
Nevada
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
Country
United States
Facility Name
Muhlenberg Regional Medical Center
City
Plainfield
State/Province
New Jersey
Country
United States
Facility Name
Neurology Group of Bergen County (Valley Hospital)
City
Ridgewood
State/Province
New Jersey
Country
United States
Facility Name
University of New Mexico Hospital
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
VA Medical Center
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
Country
United States
Facility Name
Buffalo General Hospital
City
Buffalo
State/Province
New York
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Roosevelt Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
St. Luke's Hospital
City
New York
State/Province
New York
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
Country
United States
Facility Name
Ellis Hospital
City
Schenectady
State/Province
New York
Country
United States
Facility Name
Stony Brook Hospital
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Rowan Regional Medical Center
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
Country
United States
Facility Name
Metrohealth Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Medical College of Ohio
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
St. Elizabeth Health Center
City
Youngstown
State/Province
Ohio
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
Country
United States
Facility Name
Westmoreland Regional Hospital
City
Greensburg
State/Province
Pennsylvania
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center Stroke Institute
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Crozer Chester Medical Center
City
Upland
State/Province
Pennsylvania
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Roper Hospital
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Chattanooga Neurology Associates (Erlanger Hospital)
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Chattanooga Neurology Associates (Memorial Hospital)
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
St. Thomas Hospital
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
University of Texas (Houston Medical Center)
City
Houston
State/Province
Texas
Country
United States
Facility Name
Neurological Research Center, Inc
City
Bennington
State/Province
Vermont
Country
United States
Facility Name
Neurology Associates, Inc. (St. Mary's Hospital)
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Virginia Beach General Hospital
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Stevens Memorial Hospital
City
Edmonds
State/Province
Washington
Country
United States
Facility Name
Providence St. Peter Hospital
City
Olympia
State/Province
Washington
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Theda Clark Medical Center
City
Neenah
State/Province
Wisconsin
Country
United States
Facility Name
Universitätsklinik allgemeines Krankenhaus der Stadt Wien
City
Wien
Country
Austria
Facility Name
Dienst Neurologie UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Penticton Regional Hospital
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Victoria General Hospital
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Charles LeMoyne Hospital
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
Notre-Dame Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pavillion St Joseph
City
Trois Rivers
State/Province
Quebec
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Universitätsklinikum Aachen, Neurologische Klinik
City
Aachen
Country
Germany
Facility Name
University Essen
City
Essen
Country
Germany
Facility Name
Neurologische Universitätsklinik
City
Freiburg
Country
Germany
Facility Name
Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
City
Hamburg-Eppendorf
Country
Germany
Facility Name
Neurology Klinik Klinikum Hanover
City
Hanover
Country
Germany
Facility Name
Friedrich-Schiller-University
City
Jena
Country
Germany
Facility Name
Universität zu Köln klinik und poliklinik fur neurology
City
Köln
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinik Mainz
City
Mainz
Country
Germany
Facility Name
Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
City
Munchen
Country
Germany
Facility Name
Neurologische Klinik Knappschafts - krankenhause
City
Recklinghausen
Country
Germany
Facility Name
Neurologisch Psychiayrische Klinik
City
Weisbaden
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
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