Eligibility Criteria NCT00044915 Inclusion criteria Exclusion criteria CT scan evidence of clearly defined areas of hypodensity indicating infarction of >1/3 of the MCA territory or evidence of significant mass effect with shift of midline or major areas of sulcal effacement associated with loss of cortical definition (grey-white distinction). Minor early CT changes are common in MCA strokes and patients with early or subtle changes are eligible. Yes
No
CT scan evidence of a primary intra-cerebral haemorrhage or any finding not consistent with an acute ischemic stroke as the cause of presenting symptoms Yes
No
Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure sensory deficit, ataxia/clumsy hand syndromes) Yes
No
Neurological (other than the presenting stroke) or psychiatric conditions that may affect the patient's functional status and/or that may interfere with the patient's assessment Yes
No
Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2 regardless of cause) Yes
No
Generalized seizures having developed since the onset of stroke symptoms Yes
No
Systolic blood pressure >210 or <110 mmHg (confirmed by up to three readings prior to randomization) Yes
No
Diastolic blood pressure >110 or <60 mmHg (confirmed by up to three readings prior to randomization) Yes
No
Myocardial infarction within 3 months, unstable angina within 3-5 days prior to starting infusion, unstable supra-ventricular and/or ventricular arrhythmia, severe conduction defect (AV block grades 2 and 3), complete left or right Bundle Branch Block, bradycardia (heart rate [HR] less than 50 bpm), uncompensated heart failure Yes
No
History of myocarditis, cardiomyopathy or aortic stenosis Yes
No
Patients known to have prolonged QTc intervals (inherited and sporadic syndromes of QTc prolongation or QTc interval >450 msec males and 470 msec females on baseline ECG) or using Class IA or Class III antiarrhythmic drugs (e.g., quinidine, procainamide, amiodarone, sotalol) Yes
No
Any patients that require initiation of new digoxin therapy are excluded. Patients already on digoxin therapy (for at least 1 month stable dose) at time of enrollment will be allowed in the study. Yes
No
Electrolyte imbalance at baseline. Should the results not be available before starting the study drug infusion, the patients will be allowed in the study providing that the corrective therapy of any abnormal electrolyte results is implemented immediately upon availability of the laboratory report. Yes
No
Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting, anorexia nervosa, bulimia nervosa) will also be excluded at baseline. Yes
No
Participation in a research protocol for investigation of a pharmaceutical agent or innovative invasive procedure (including intra-arterial t-PA) within the past 30 days Yes
No
Previously in the BRAIN-Study or treated with repinotan Yes
No
Life expectancy of less than 6 months due to comorbid conditions Yes
No
Any other known clinically significant medical disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, endocrine, major uncompensated metabolic disturbances, respiratory, immunological, hematological or bleeding disorder, cancer, AIDS) Yes
No
