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



Status:Terminated
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:April 2009

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
83
sites
Troy, Michigan 48085
?
mi
from
Troy, MI
Click here to add this to my saved trials
Albany, New York 12208
?
mi
from
Albany, NY
Click here to add this to my saved trials
Allentown, Pennsylvania 18103
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Atlanta, Georgia 30303
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21231
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brooklyn, New York 11220
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brugge,
?
mi
from
Brugge,
Click here to add this to my saved trials
Buffalo, New York 14209
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Castro Valley, California 94546
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60622
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cleveland, Ohio 44109
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Columbus, Georgia 31902
?
mi
from
Columbus, GA
Click here to add this to my saved trials
Columbus, Ohio 43210
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Des Moines, Iowa 50314
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan 48236
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Detroit, Michigan
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Edison, New Jersey 08818
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Englewood, Colorado 80113
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Evanston, Illinois 60201
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fairfield, Connecticut 06824
?
mi
from
Fairfield, CT
Click here to add this to my saved trials
Glenview, Illinois 60026
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Grand Blanc, Michigan 48439
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Gulfport, Mississippi 39502
?
mi
from
Gulfport, MS
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46260
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Kalamazoo, Michigan 49007
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lawrenceville, Georgia 30045
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Loma Linda, California 92354
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Los Angeles, California 90024
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
Maywood, Illinois 60153
?
mi
from
Maywood, IL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Nashville, Tennessee 37205
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Neptune, New Jersey 07753
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
New Haven, Connecticut 06510
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Oak Lawn, Illinois 60453
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pensacola, Florida 32504
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Petoskey, Michigan 49770
?
mi
from
Petoskey, MI
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19141
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85054
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburg, Pennsylvania 15213
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
Pittsburg, Pennsylvania 15212
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
Providence, Rhode Island 02903
?
mi
from
Providence, RI
Click here to add this to my saved trials
Richmond, Virginia 23298
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Ridgewood, New Jersey 07450
?
mi
from
Ridgewood, NJ
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
Santa Barbara, California 93105
?
mi
from
Santa Barbara, CA
Click here to add this to my saved trials
Savannah, Georgia 31405
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Savannah, Georgia 31419
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Shreveport, Louisiana 71130
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Southfield, Michigan 48075
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Southfield, Michigan 48075
?
mi
from
Southfield, MI
Click here to add this to my saved trials
Springfield, Missouri 65807
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Springfield, Oregon 97477
?
mi
from
Springfield, OR
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Thousand Oaks, California 91360
?
mi
from
Thousand Oaks, CA
Click here to add this to my saved trials
Toledo, Ohio 43614
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Winchester, Virginia 22601
?
mi
from
Winchester, VA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
Worcester, Massachusetts 01605
?
mi
from
Worcester, MA
Click here to add this to my saved trials