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

Completed · Phase 2

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT00044057

Run by

Astellas Pharma Inc

Starts

2000-12-01

Expected to finish

2003-01-01

Last updated by the study team

2006-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Other exclusion criteria as specified by the study protocol

Where it is running

• 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
• University of South Alabama Stroke Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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