Repinotan in Patients With Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00044915
First received: September 6, 2002
Last updated: June 9, 2009
Last verified: June 2009
  Purpose

The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.


Condition Intervention Phase
Stroke
Acute Ischemic Stroke
Drug: Repinotan HCl (BAYX3702)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Enrollment: 782
Study Start Date: December 2000
Study Completion Date: September 2004
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: Repinotan HCl (BAYX3702)
All patients receive 1.25 mg of repinotan
Placebo Comparator: Arm 2 Drug: Placebo
All patients receive 1.25 mg of placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044915

  Show 119 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00044915     History of Changes
Other Study ID Numbers: 100282
Study First Received: September 6, 2002
Last Updated: June 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Acute Ischemic Stroke Without Hemorrhage

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 16, 2014