Clinical trial NCT00044057: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: ARTIST
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2002-08-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Stroke Center
state: Alabama
city: Phoenix
country: United States
facility: Good Samaritan Hospital
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Berkeley
country: United States
facility: East Bay Region Associates in Neurology
state: California
city: Burbank
country: United States
facility: Providence St. Joseph's Medical Center
state: California
city: Carmichael
country: United States
facility: Mercy San Juan Hospital
state: California
city: Davis
country: United States
facility: University of California Davis Medical Center
state: California
city: Encinitas
country: United States
facility: Scripps Memorial Hospital
state: California
city: La Mesa
country: United States
facility: Grossmont Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Oceanside
country: United States
facility: Tri-City Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: Scripps Mercy Hospital
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center - Santa Monica
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center
state: California
city: Walnut Creek
country: United States
facility: Mt Diablo Medical Center
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Atlantis
country: United States
facility: Columbia JFK Hospital
state: Florida
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Panama City
country: United States
facility: Bay Medical Center
state: Florida
city: Tampa
country: United States
facility: St Joseph's Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Columbus
country: United States
facility: St Francis Hospital
state: Georgia
city: Decatur
country: United States
facility: DNA Research (Dekalb Medical Center)
state: Georgia
city: Savannah
country: United States
facility: Candler Hospital
state: Georgia
city: Savannah
country: United States
facility: St Joseph Hospital
state: Georgia
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital
state: Indiana
city: Louisville
country: United States
facility: Louisville Neuroscience Research Center
state: Kentucky
city: Marrero
country: United States
facility: Culicchia Neurology Clinic, LLP
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: St John's Hospital
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Traverse City
country: United States
facility: Northern Michigan Neurology
state: Michigan
city: Warren
country: United States
facility: Bi-County Hospital
state: Michigan
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists (Benefis Healthcare Hospital)
state: Montana
city: Reno
country: United States
facility: Washoe Comprehensive Stroke Center
state: Nevada
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Plainfield
country: United States
facility: Muhlenberg Regional Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: Neurology Group of Bergen County (Valley Hospital)
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Hospital
state: New Mexico
city: Albuquerque
country: United States
facility: VA Medical Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Hospital
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: New York
country: United States
facility: Roosevelt Hospital
state: New York
city: New York
country: United States
facility: St. Luke's Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Schenectady
country: United States
facility: Ellis Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Hospital
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Rowan Regional Medical Center
state: North Carolina
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Medical College of Ohio
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Health Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Greensburg
country: United States
facility: Westmoreland Regional Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Stroke Institute
state: Pennsylvania
city: Upland
country: United States
facility: Crozer Chester Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Neurology Associates (Erlanger Hospital)
state: Tennessee
city: Chattanooga
country: United States
facility: Chattanooga Neurology Associates (Memorial Hospital)
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas (Houston Medical Center)
state: Texas
city: Bennington
country: United States
facility: Neurological Research Center, Inc
state: Vermont
city: Richmond
country: United States
facility: Neurology Associates, Inc. (St. Mary's Hospital)
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Beach General Hospital
state: Virginia
city: Edmonds
country: United States
facility: Stevens Memorial Hospital
state: Washington
city: Olympia
country: United States
facility: Providence St. Peter Hospital
state: Washington
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Neenah
country: United States
facility: Theda Clark Medical Center
state: Wisconsin
city: Wien
country: Austria
facility: Universitätsklinik allgemeines Krankenhaus der Stadt Wien
city: Leuven
country: Belgium
facility: Dienst Neurologie UZ Gasthuisberg
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Penticton
country: Canada
facility: Penticton Regional Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Greenfield Park
country: Canada
facility: Charles LeMoyne Hospital
state: Quebec
city: Montreal
country: Canada
facility: Notre-Dame Hospital
state: Quebec
city: Trois Rivers
country: Canada
facility: Pavillion St Joseph
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, Neurologische Klinik
city: Essen
country: Germany
facility: University Essen
city: Freiburg
country: Germany
facility: Neurologische Universitätsklinik
city: Hamburg-Eppendorf
country: Germany
facility: Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
city: Hanover
country: Germany
facility: Neurology Klinik Klinikum Hanover
city: Jena
country: Germany
facility: Friedrich-Schiller-University
city: Köln
country: Germany
facility: Universität zu Köln klinik und poliklinik fur neurology
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsklinik Mainz
city: Munchen
country: Germany
facility: Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
city: Recklinghausen
country: Germany
facility: Neurologische Klinik Knappschafts - krankenhause
city: Weisbaden
country: Germany
facility: Neurologisch Psychiayrische Klinik
Study officials:
References: