Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

This study is currently recruiting participants.

Verified April 2013 by H. Lundbeck A/S

Sponsor:

Information provided by (Responsible Party):

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT00856661

First received: March 5, 2009

Last updated: April 13, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2009

Last Updated Date

April 13, 2013

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00856661 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

Official Title ^ICMJE

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

Brief Summary

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 to 9 hours from onset of stroke symptoms.

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 to 9 hours after onset of stroke symptoms.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Drug: Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day
Drug: Placebo
IV, single bolus over 1 to 2 minutes on 1st day

Study Arm (s)

Experimental: Desmoteplase
Intervention: Drug: Desmoteplase
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Not Provided

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of acute ischemic stroke
Informed consent
Age between 18 and 85 years
Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms
NIHSS Score of 4 to 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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Location Countries ^ICMJE

United States, Belgium, Brazil, Canada, Chile, Denmark, Finland, Ireland, Italy, Mexico, Norway, South Africa, Sweden, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00856661

Other Study ID Numbers ^ICMJE

12649A, 2008-005539-14

Has Data Monitoring Committee

Yes

Responsible Party

H. Lundbeck A/S

Study Sponsor ^ICMJE

H. Lundbeck A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Information Provided By

H. Lundbeck A/S

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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