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CompletedNCT00044915Updated Jun 12, 2009

Repinotan in Patients With Acute Ischemic Stroke

A Phase 2 interventional study of Repinotan HCl (BAYX3702) and Placebo in Stroke and Acute Ischemic Stroke, sponsored by Bayer. Completed at 119 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-12.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
782
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Acute Ischemic Stroke

Keywords

  • Acute Ischemic Stroke Without Hemorrhage
03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 782 is above the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
782 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Drug: Repinotan HCl (BAYX3702)

  • Placebo comparator
    Arm 2

    Drug: Placebo

Interventions

  • DrugRepinotan HCl (BAYX3702)

    All patients receive 1.25 mg of repinotan

  • DrugPlacebo

    All patients receive 1.25 mg of placebo

06

Study locations

119 sites
  • Los Angeles, California 90024-1777, United States
  • Oceanside, California 92056-4405, United States
  • San Diego, California 92103-8765, United States
  • San Jose, California 95124, United States
  • Boynton Beach, Florida 33435-6000, United States
  • Fort Lauderdale, Florida 33308, United States
  • Ocala, Florida 34471, United States
  • Tampa, Florida 33606, United States
  • Decatur, Georgia 30033, United States
  • Honolulu, Hawaii 96813-2413, United States
  • Des Moines, Iowa 50314, United States
  • Baltimore, Maryland 21224, United States
  • Robbinsdale, Minnesota 55422-2900, United States
  • Great Falls, Montana 59405, United States
  • Edison, New Jersey 08818-3903, United States
  • Ridgewood, New Jersey 07450, United States
  • New Hyde Park, New York 11040-1496, United States
  • Stony Brook, New York 11794, United States
  • Chapel Hill, North Carolina 27599-7065, United States
  • Winston-Salem, North Carolina 27103, United States
  • Cleveland, Ohio 44109-1998, United States
  • Portland, Oregon 97225, United States
  • Philadelphia, Pennsylvania 19107, United States
  • Upland, Pennsylvania 19013-3995, United States
  • Beaufort, South Carolina 29902-5472, United States
  • Chattanooga, Tennessee 37403-2112, United States
  • Houston, Texas 77030, United States
  • Bellevue, Washington 98004-4687, United States
  • Gosford, New South Wales 2250, Australia
  • New Lambton Heights, New South Wales 2305, Australia
  • Southport, Queensland 4215, Australia
  • Hobart, Tasmania 7000, Australia
  • Melbourne, Victoria 3011, Australia
  • Melbourne, Victoria 3052, Australia
  • Melbourne, Victoria 3084, Australia
  • Melbourne, Victoria 3181, Australia
  • Klosterneuburg, Lower Austria 3400, Austria
  • Vienna, State of Vienna 1021, Austria
  • Linz, Upper Austria 4020, Austria
  • Bornem, 2880, Belgium
  • Bruxelles - Brussel, 1200, Belgium
  • Calgary, Alberta T2N 2T9, Canada
  • Edmonton, Alberta T6G 2B7, Canada
  • Lethbridge, Alberta T1KOC9, Canada
  • North Vancouver, British Columbia V7L 2L3, Canada
  • Penticton, British Columbia V2A 3G6, Canada
  • Vancouver, British Columbia V5Z 1M9, Canada
  • Victoria, British Columbia V8Z 6R5, Canada
  • Winnipeg, Manitoba R2H 2A6, Canada
  • Saint John, New Brunswick E2L 4L2, Canada
  • Halifax, Nova Scotia B3H 3A7, Canada
  • London, Ontario N6A 5A5, Canada
  • Mississauga, Ontario L5B 1B8, Canada
  • Ottawa, Ontario K1H 8L6, Canada
  • Toronto, Ontario M5T 2S8, Canada
  • Chicoutimi, Quebec G7H 5H6, Canada
  • Greenfield Park, Quebec J4V 2H1, Canada
  • Québec, Quebec G1J 1Z4, Canada
  • Saskatoon, Saskatchewan S7N 0W8, Canada
  • Helsinki, 00290, Finland
  • Kuopio, 70120, Finland
  • Lahti, 15850, Finland
  • Mikkeli, FIN-50100, Finland
  • Bordeaux, 33000, France
  • Nice, 06200, France
  • Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany
  • Heidelberg, Baden-Wurttemberg 69120, Germany
  • Tübingen, Baden-Wurttemberg 72076, Germany
  • Aschaffenburg, Bavaria 63739, Germany
  • Bad Neustadt an der Saale, Bavaria 97616, Germany
  • Erlangen, Bavaria 91054, Germany
  • München, Bavaria 81377, Germany
  • München, Bavaria 81545, Germany
  • Nuremberg, Bavaria 90419, Germany
  • Regensburg, Bavaria 93053, Germany
  • Würzburg, Bavaria 97080, Germany
  • Frankfurt am Main, Hesse 60596, Germany
  • Greifswald, Mecklenburg-Vorpommern 17489, Germany
  • Cologne, North Rhine-Westphalia 50931, Germany
  • Essen, North Rhine-Westphalia 45147, Germany
  • Minden, North Rhine-Westphalia 32427, Germany
  • Münster, North Rhine-Westphalia 48149, Germany
  • Kaiserslautern, Rhineland-Palatinate 67655, Germany
  • Leipzig, Saxony 04103, Germany
  • Magdeburg, Saxony-Anhalt 39112, Germany
  • Berlin, State of Berlin 10117, Germany
  • Berlin, State of Berlin 10249, Germany
  • Miskolc, 3526, Hungary
  • Petah Tikva, Isarel 49372, Israel
  • Ashkelon, 78306, Israel
  • Haifa, 31048, Israel
  • Haifa, 31096, Israel
  • Holon, 58100, Israel
  • Nahariya, 22100, Israel
  • Tel Aviv, 64239, Israel
  • Tel Litwinsky, 52621, Israel
  • Como, 22100, Italy
  • L’Aquila, 67100, Italy
  • Milan, 20153, Italy
  • Pavia, 27100, Italy

Showing the first 100 of 119 sites across 15 countries.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00044915
Lead sponsor
Bayer
First posted
Sep 9, 2002
Start date
Dec 2000
Completion
Sep 2004
Last update
Jun 12, 2009

Study contacts

Bayer Study Director
study director · Bayer
View the source record on ClinicalTrials.gov ↗

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