Repinotan in Patients With Acute Ischemic Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00044915
• Date of registration: 06/09/2002
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: Repinotan in Patients With Acute Ischemic Stroke
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke
• Date of first enrolment: December 2000
• Target sample size: 782
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00044915
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Acute ischemic stroke of hemispheric localization (exclude brainstem and cerebellum),
of suspected thromboembolic origin.

- Males or females aged 18 years or over.

- National Institute of Health Stroke Scale (NIH-SS) total score 8 to 23 with a motor
deficit >/= 2 (for either one arm or leg) and level of consciousness < 2 and at least
one of the following: Visual field deficit, neglect, or aphasia. If a patient
receives t-PA, NIH-SS must be performed prior to receiving the study drug but after
infusion of t-PA is initiated.

- Signed informed consent from patient or legally authorized representative

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.

- A primary intra-cerebral haemorrhage or any finding not consistent with an acute
ischemic stroke as the cause of presenting symptoms.

- Clinical evidence of acute stroke due to lacunar infarct (pure motor hemiplegia; pure
sensory deficit, ataxia/clumsy hand syndromes)

- 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

- Clinically relevant pre-existing neurological deficit (Historical Rankin score >/= 2
regardless of cause)

- Generalized seizures having developed since the onset of stroke symptoms

- Systolic blood pressure > 210 or < 110 mmHg (confirmed by up to three readings prior
to randomization)

- Diastolic blood pressure > 110 or < 60 mmHg (confirmed by up to three readings prior
to randomization)

- 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

- History of myocarditis, cardiomyopathy or aortic stenosis

- 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)

- 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.

- 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.

- Any conditions predisposing to electrolyte imbalances (e.g., chronic vomiting,
anorexia nervosa, bulimia nervosa) will also be excluded at baseline.

- 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

- Previously in the BRAIN-Study or treated with repinotan

- Life expectancy of less than 6 months due to comorbid conditions

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Ischemic Stroke

Stroke

Intervention(s)

Drug: Placebo

Drug: Repinotan HCl (BAYX3702)

Secondary ID(s)

100282

Source(s) of Monetary Support

Please refer to primary and secondary sponsors