A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)

Phase 2

Completed

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT00044057
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Study First Submitted: 2002-08-16
• Study First Submitted QC: 2002-08-19
• Study First Posted: 2002-08-20
• Study Completion: 2003-01
• Status Verified: 2006-03
• Last Update Submitted: 2006-03-31
• Last Update Posted: 2006-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (117)

University of Pennsylvania Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Maryland Medical System; 🇺🇸 Baltimore, Maryland, United States

Dienst Neurologie UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Pavillion St Joseph; 🇨🇦 Trois Rivers, Quebec, Canada

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Texas (Houston Medical Center); 🇺🇸 Houston, Texas, United States

Scripps Mercy Hospital; 🇺🇸 San Diego, California, United States

University of California at San Diego; 🇺🇸 San Diego, California, United States

St. Thomas Hospital; 🇺🇸 Nashville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

University of California Davis Medical Center; 🇺🇸 Davis, California, United States

Providence St. Joseph's Medical Center; 🇺🇸 Burbank, California, United States

East Bay Region Associates in Neurology; 🇺🇸 Berkeley, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Scripps Memorial Hospital; 🇺🇸 Encinitas, California, United States

Good Samaritan Hospital; 🇺🇸 San Jose, California, United States

Mercy San Juan Hospital; 🇺🇸 Carmichael, California, United States

Tri-City Medical Center; 🇺🇸 Oceanside, California, United States

Michigan State University; 🇺🇸 East Lansing, Michigan, United States

University of South Alabama Stroke Center; 🇺🇸 Mobile, Alabama, United States

UCLA Medical Center - Santa Monica; 🇺🇸 Santa Monica, California, United States

Bi-County Hospital; 🇺🇸 Warren, Michigan, United States

OSF St. Francis Medical Center; 🇺🇸 Peoria, Illinois, United States

St Francis Hospital; 🇺🇸 Columbus, Georgia, United States

Stony Brook Hospital; 🇺🇸 Stony Brook, New York, United States

Columbia JFK Hospital; 🇺🇸 Atlantis, Florida, United States

Bethesda Memorial Hospital; 🇺🇸 Boynton Beach, Florida, United States

Mt Diablo Medical Center; 🇺🇸 Walnut Creek, California, United States

New England Medical Center; 🇺🇸 Boston, Massachusetts, United States

Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

St John's Hospital; 🇺🇸 Detroit, Michigan, United States

Long Island Jewish Medical Center; 🇺🇸 New Hyde Park, New York, United States

Candler Hospital; 🇺🇸 Savannah, Georgia, United States

Parkview Hospital; 🇺🇸 Fort Wayne, Indiana, United States

Buffalo General Hospital; 🇺🇸 Buffalo, New York, United States

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States

Roosevelt Hospital; 🇺🇸 New York, New York, United States

Neurology Group of Bergen County (Valley Hospital); 🇺🇸 Ridgewood, New Jersey, United States

Akron General Medical Center; 🇺🇸 Akron, Ohio, United States

Medical College of Ohio; 🇺🇸 Toledo, Ohio, United States

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Westmoreland Regional Hospital; 🇺🇸 Greensburg, Pennsylvania, United States

Albany Medical Center; 🇺🇸 Albany, New York, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Ellis Hospital; 🇺🇸 Schenectady, New York, United States

University of Pittsburgh Medical Center Stroke Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States

St. Elizabeth Health Center; 🇺🇸 Youngstown, Ohio, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States

Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Charles LeMoyne Hospital; 🇨🇦 Greenfield Park, Quebec, Canada

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Theda Clark Medical Center; 🇺🇸 Neenah, Wisconsin, United States

Crozer Chester Medical Center; 🇺🇸 Upland, Pennsylvania, United States

Chattanooga Neurology Associates (Memorial Hospital); 🇺🇸 Chattanooga, Tennessee, United States

Virginia Beach General Hospital; 🇺🇸 Virginia Beach, Virginia, United States

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Neurologische Klinik Klinikum Rechts der Isar der TU Munchen; 🇩🇪 Munchen, Germany

Neurologische Klinik Knappschafts - krankenhause; 🇩🇪 Recklinghausen, Germany

Universitätsklinik Mainz; 🇩🇪 Mainz, Germany

Neurology Klinik Klinikum Hanover; 🇩🇪 Hanover, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Universität zu Köln klinik und poliklinik fur neurology; 🇩🇪 Köln, Germany

Neurologisch Psychiayrische Klinik; 🇩🇪 Weisbaden, Germany

Friedrich-Schiller-University; 🇩🇪 Jena, Germany

Universitätsklinikum Aachen, Neurologische Klinik; 🇩🇪 Aachen, Germany

Rochester General Hospital; 🇺🇸 Rochester, New York, United States

St. Luke's Hospital; 🇺🇸 New York, New York, United States

Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Research Medical Center; 🇺🇸 Kansas City, Missouri, United States

Stevens Memorial Hospital; 🇺🇸 Edmonds, Washington, United States

Roper Hospital; 🇺🇸 Charleston, South Carolina, United States

Lakeland Regional Medical Center; 🇺🇸 Lakeland, Florida, United States

Bay Medical Center; 🇺🇸 Panama City, Florida, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

St Joseph's Hospital; 🇺🇸 Tampa, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Louisville Neuroscience Research Center; 🇺🇸 Louisville, Kentucky, United States

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Rowan Regional Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

St Joseph Hospital; 🇺🇸 Savannah, Georgia, United States

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

Holmes Regional Medical Center; 🇺🇸 Melbourne, Florida, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Grossmont Hospital; 🇺🇸 La Mesa, California, United States

Colorado Neurological Institute; 🇺🇸 Englewood, Colorado, United States

John Muir Medical Center; 🇺🇸 Walnut Creek, California, United States

DNA Research (Dekalb Medical Center); 🇺🇸 Decatur, Georgia, United States

Washoe Comprehensive Stroke Center; 🇺🇸 Reno, Nevada, United States

JFK Medical Center; 🇺🇸 Edison, New Jersey, United States

Northern Michigan Neurology; 🇺🇸 Traverse City, Michigan, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

VA Medical Center; 🇺🇸 Albuquerque, New Mexico, United States

University of New Mexico Hospital; 🇺🇸 Albuquerque, New Mexico, United States

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Providence St. Peter Hospital; 🇺🇸 Olympia, Washington, United States

Universitätskrankenhaus Hamburg-Eppendorf Klinik für Neurologie; 🇩🇪 Hamburg-Eppendorf, Germany

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

University Essen; 🇩🇪 Essen, Germany

Neurologische Universitätsklinik; 🇩🇪 Freiburg, Germany

Victoria General Hospital; 🇨🇦 Victoria, British Columbia, Canada

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Neurological Research Center, Inc; 🇺🇸 Bennington, Vermont, United States

Penticton Regional Hospital; 🇨🇦 Penticton, British Columbia, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Universitätsklinik allgemeines Krankenhaus der Stadt Wien; 🇦🇹 Wien, Austria

Metrohealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Culicchia Neurology Clinic, LLP; 🇺🇸 Marrero, Louisiana, United States

Advanced Neurology Specialists (Benefis Healthcare Hospital); 🇺🇸 Great Falls, Montana, United States

Chattanooga Neurology Associates (Erlanger Hospital); 🇺🇸 Chattanooga, Tennessee, United States

Notre-Dame Hospital; 🇨🇦 Montreal, Quebec, Canada

Muhlenberg Regional Medical Center; 🇺🇸 Plainfield, New Jersey, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

Neurology Associates, Inc. (St. Mary's Hospital); 🇺🇸 Richmond, Virginia, United States