Clinical trial NCT00044915: Repinotan in Patients With Acute Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke Without Hemorrhage
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2002-09-09
Enrollment: 782
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Des Moines
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Robbinsdale
country: United States
state: Minnesota
city: Great Falls
country: United States
state: Montana
city: Edison
country: United States
state: New Jersey
city: Ridgewood
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Beaufort
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Bellevue
country: United States
state: Washington
city: Gosford
country: Australia
state: New South Wales
city: New Lambton Heights
country: Australia
state: New South Wales
city: Southport
country: Australia
state: Queensland
city: Hobart
country: Australia
state: Tasmania
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Klosterneuburg
country: Austria
state: Niederösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Wien
country: Austria
city: Bornem
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Lethbridge
country: Canada
state: Alberta
city: North Vancouver
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: St. John
country: Canada
state: New Brunswick
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Mikkeli
country: Finland
city: Bordeaux
country: France
city: Nice
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: Aschaffenburg
country: Germany
state: Bayern
city: Bad Neustadt
country: Germany
state: Bayern
city: Erlangen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Nürnberg
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Würzburg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Minden
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Miskolc
country: Hungary
city: Petach Tikva
country: Israel
state: Isarel
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Nahariya
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Como
country: Italy
city: L'Aquila
country: Italy
city: Milano
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Verona
country: Italy
city: Vibo Valentia
country: Italy
city: Vicenza
country: Italy
city: Groningen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Stockholm
country: Sweden
city: Umeå
country: Sweden
city: Leicester
country: United Kingdom
state: Leicestershire
city: Glasgow
country: United Kingdom
state: Strathclyde
city: Dundee
country: United Kingdom
state: Tayside
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: