Clinical trial NCT00044070: A Study to Evaluate the Effects of YM872 on Stroke Lesion Volume in Acute Stroke Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Effects of YM872 on Lesion Volume as Measured by Diffusion, Perfusion, and FLAIR Magnetic Resonance Imaging in Patients With Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebrovascular Accident
Keywords: ARTIST
Acute ischemic stroke
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

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: Phoenix Neurology Associates (Good Samaritan Hospital)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Burbank
country: United States
facility: Providence St. Joseph's Medical Center
state: California
city: La Mesa
country: United States
facility: Grossmont Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Emergency Medical Center
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital
state: California
city: Santa Monica
country: United States
facility: Santa Monica UCLA Medical Center
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Boynton Beach
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami (Jackson Memorial Hospital)
state: Florida
city: Tampa
country: United States
facility: Florida Neurovascular Institute
state: Florida
city: Decatur
country: United States
facility: DNA Research (Dekalb Medical Center)
state: Georgia
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: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Louisville Neuroscience Research Center
state: Kentucky
city: Marrero
country: United States
facility: Cullicchia Neurology Clinic, LLP
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institute
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: Wayne State University
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: Saginaw
country: United States
facility: Field Neurosciences Institute (St. Mary's Hospital)
state: Michigan
city: Great Falls
country: United States
facility: Advanced Neurology Specialists (Benefis Healthcare Hospital)
state: Montana
city: Missoula
country: United States
facility: St. Patrick's Hospital & Health Sciences Center
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: 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: St. Luke's 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: All-Trials Clinical Research, LLC (Rowan Regional Medical Center)
state: North Carolina
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: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Stroke Institute
state: Pennsylvania
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: 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: Spokane
country: United States
facility: Sacred Heart Medical Center
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
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Bruxelles
country: Belgium
facility: Service de Neurologie, Cliniques Universitaires St.-Luc
city: Leuven
country: Belgium
facility: Dienst Neurologie UZ Gasthuisberg
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, Neurologische Klinik
city: Essen
country: Germany
facility: University of Essen
city: Freiburg
country: Germany
facility: Neurologische Universitätsklinik, Albert-Ludwigs-University
city: Hamburg-Eppendorf
country: Germany
facility: Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie
city: Homburg Saar
country: Germany
facility: Universitatklinikum Homburg, Neurologie Klinik und Poliklinik
city: Jena
country: Germany
facility: Friedrich-Schiller-University
city: Koln
country: Germany
facility: Universität zu Köln klinik und poliklinik fur neurology
city: Leipzig
country: Germany
facility: Universitatklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsklinik Mainz
city: Minden
country: Germany
facility: Department of Neurology Klinikum
city: Munchen
country: Germany
facility: Neurologische Klinik Klinikum Rechts der Isar der TU Munchen
city: Recklinghausen
country: Germany
facility: Neurologische Klinik Knappschafts - krankenhause
city: Wiesbaden
country: Germany
facility: Dr.-H.-Schmidt-Kliniken Ludwig-Erhar
city: Arcadia
country: South Africa
facility: Muelmed Hospital
city: Bloemfontein
country: South Africa
facility: Bloemfontein Medi-Clinic
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Durban
country: South Africa
facility: St. Augustine's Hospital
city: Johannesburg
country: South Africa
facility: Sandton Medi-Clinic
city: Pietermaritzburg
country: South Africa
facility: Pietermaritzburg Medi-Clinic
city: Pretoria
country: South Africa
facility: Little Company of Mary Medical Centre
city: Somerset West
country: South Africa
facility: Vergelegen Medi-Clinic
city: Sunninghill
country: South Africa
facility: Sunninghill Hospital
Study officials:
References: