Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke - Full Text View

Sponsor:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00790920

Purpose

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

Condition	Intervention	Phase
Stroke	Drug: Desmoteplase Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke

Resource links provided by NLM:

Drug Information available for: Desmoteplase

U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Modified Rankin Scale Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	320
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Desmoteplase: Experimental	Drug: Desmoteplase 90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
Placebo: Placebo Comparator	Drug: Placebo IV, single bolus over 1 - 2 minutes on 1st day

Detailed Description:

Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.

The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of acute ischemic stroke
Informed consent
Age between 18 and 85 years
Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
NIHSS Score of 4-24
Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries

Exclusion Criteria:

Pre-stroke mRS >1
Previous exposure to desmoteplase
Extensive early infarction on MRI or CT in any affected area
Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
Internal carotid artery occlusion on the side of the stroke lesion
Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
Treatment with oral anticoagulants and a prolonged prothrombin time
Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
Treatment with a thrombolytic agent within the past 72 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790920

Contacts

Contact: Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Show 35 Study Locations

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12402A, EudraCT 2008-000622-40
Study First Received:	November 13, 2008
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00790920 History of Changes
Health Authority:	Austria: Agency for Health and Food Safety; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Netherlands: Ministry of Health, Welfare and Sport; Singapore: Health Sciences Authority; Taiwan: National Bureau of Controlled Drugs

Keywords provided by H. Lundbeck A/S:

Acute ischemic stroke
Angiography
Desmoteplase
Thrombolytic

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents

Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Salivary plasminogen activator alpha 1, Desmodus rotundus

ClinicalTrials.gov processed this record on November 20, 2009