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