Study Stopped
The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
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
2 other identifiers
interventional
270
14 countries
152
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 stroke
152 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedResults Posted
Study results publicly available
December 22, 2015
CompletedMarch 16, 2017
February 1, 2017
5.5 years
March 5, 2009
October 6, 2015
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)
The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke
Day 90
Secondary Outcomes (3)
National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)
90 days
Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)
Day 90
Modified Ranking Scale Score (Using the Ordinal Scale)
Day 90
Study Arms (2)
Desmoteplase
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (152)
US053
Phoenix, Arizona, 85054, United States
US081
Castro Valley, California, 94546, United States
US089
La Jolla, California, 92037, United States
US043
Loma Linda, California, 92354, United States
US008
Los Angeles, California, 90024-1777, United States
US020
Palo Alto, California, 94304, United States
US050
Pasadena, California, 91105, United States
US098
Santa Barbara, California, 93105, United States
US051
Thousand Oaks, California, 91360, United States
US068
Englewood, Colorado, 80113, United States
US063
Fairfield, Connecticut, 06824, United States
US104
New Haven, Connecticut, 06510, United States
US049
Pensacola, Florida, 32504, United States
US109
Atlanta, Georgia, 30303, United States
US042
Augusta, Georgia, 30912, United States
US052
Columbus, Georgia, 31902, United States
US080
Decatur, Georgia, 30033, United States
US040
Lawrenceville, Georgia, 30045, United States
US067
Macon, Georgia, 31201, United States
US085
Savannah, Georgia, 31405, United States
US086
Savannah, Georgia, 31419, United States
US093
Chicago, Illinois, 60611, United States
US101
Chicago, Illinois, 60612, United States
US044
Chicago, Illinois, 60622, United States
US074
Evanston, Illinois, 60201, United States
US073
Glenview, Illinois, 60026, United States
US091
Maywood, Illinois, 60153, United States
US088
Oak Lawn, Illinois, 60453, United States
US016
Indianapolis, Indiana, 46260, United States
US072
Des Moines, Iowa, 50314-2611, United States
US061
New Orleans, Louisiana, 70112, United States
US108
New Orleans, Louisiana, 70121, United States
US064
Shreveport, Louisiana, 71130-3932, United States
US014
Baltimore, Maryland, 21231, United States
US039
Boston, Massachusetts, 02114, United States
US003
Boston, Massachusetts, 02118, United States
US017
Worcester, Massachusetts, 01605, United States
US066
Detroit, Michigan, 48201, United States
US096
Detroit, Michigan, 48202, United States
US083
Detroit, Michigan, 48236, United States
US060
Grand Blanc, Michigan, 48439, United States
US078
Grand Rapids, Michigan, 49503, United States
US103
Kalamazoo, Michigan, 49007, United States
US056
Petoskey, Michigan, 49770, United States
US113
Royal Oak, Michigan, 48073, United States
US076
Southfield, Michigan, 48075, United States
US082
Southfield, Michigan, 48075, United States
US079
Troy, Michigan, 48085, United States
US059
Gulfport, Mississippi, 39502, United States
US048
Springfield, Missouri, 65807, United States
US077
Lebanon, New Hampshire, 03756, United States
US055
Edison, New Jersey, 08818, United States
US115
Neptune City, New Jersey, 07753, United States
US100
Ridgewood, New Jersey, 07450, United States
US075
Albany, New York, 12208, United States
US102
Brooklyn, New York, 11220, United States
US012
Buffalo, New York, 14203, United States
US026
Stony Brook, New York, 11794-8121, United States
US037
Greensboro, North Carolina, 27401, United States
US069
Winston-Salem, North Carolina, 27157, United States
US038
Cleveland, Ohio, 44109, United States
US001
Columbus, Ohio, 43210, United States
US062
Columbus, Ohio, 43214, United States
US046
Toledo, Ohio, 43614, United States
US095
Springfield, Oregon, 97477, United States
US070
Allentown, Pennsylvania, 18103, United States
US023
Philadelphia, Pennsylvania, 19141, United States
US099
Pittsburgh, Pennsylvania, 15212, United States
US084
Pittsburgh, Pennsylvania, 15213, United States
US092
Providence, Rhode Island, 02903, United States
US087
Warwick, Rhode Island, 02886, United States
US057
Columbia, South Carolina, 29203, United States
US019
Chattanooga, Tennessee, 37403, United States
US058
Nashville, Tennessee, 37205, United States
US021
Houston, Texas, 77030, United States
US031
Houston, Texas, 77030, United States
US112
Houston, Texas, 77030, United States
US047
Richmond, Virginia, 23298, United States
US006
Winchester, Virginia, 22601, United States
US011
Madison, Wisconsin, 53792, United States
US097
Milwaukee, Wisconsin, 53226, United States
BE008
Bruges, 8000, Belgium
BE004
Hasselt, 3500, Belgium
BE005
Roeselare, 8800, Belgium
BE006
Wilrijk, 2610, Belgium
BR012
Campinas, 13083-970, Brazil
BR004
Porto Alegre, 90020-090, Brazil
BR008
Porto Alegre, 90035-003, Brazil
BR007
Porto Alegre, 90110-270, Brazil
BR009
Rio de Janeiro, 20941-150, Brazil
BR011
Rio de Janeiro, 22280-000, Brazil
BR006
Salvador, 40140-110, Brazil
CA001
Calgary, Alberta, T2N 2T9, Canada
CA004
Edmonton, T6L 5X8, Canada
CA006
Halifax, B3H 3A7, Canada
CA008
Mississauga, L5B 1B8, Canada
CA007
Ottawa, K1Y 4E9, Canada
CA012
Toronto, M4N 3M5, Canada
CA002
Toronto, M5T 2S8, Canada
CA005
Victoria, V8R 1J8, Canada
CL002
Santiago, Chile
CL003
Santiago, Chile
CL004
Santiago, Chile
CL006
Santiago, Chile
CL005
ValparaĂso, Chile
DK002
Aalborg, 9000, Denmark
DK001
Aarhus, 8000, Denmark
DK004
Copenhagen NV, 2400, Denmark
DK003
Glostrup Municipality, 2600, Denmark
FI001
Helsinki, 29, Finland
FI002
Tampere, 33520, Finland
FI003
Turku, 20520, Finland
IE001
Dublin, 8, Ireland
IT010
Ancona, 60020, Italy
IT008
Brescia, 25123, Italy
IT003
Florence, 50019, Italy
IT004
Imperia, 18100, Italy
IT002
Milan, 20132, Italy
IT006
Milan, 20153, Italy
IT009
Milan, 20162, Italy
IT012
Modena, 41100, Italy
IT001
Rome, 161, Italy
IT005
Rome, 189, Italy
IT007
Rozzano, 20089, Italy
IT011
Verona, 37126, Italy
MX002
D.f., 14269, Mexico
MX003
Mexico City, 14000, Mexico
MX004
Mexico City, 14050, Mexico
MX005
Monterrey Nuevo Leon, Mexico
NO003
Bergen, 2021, Norway
NO001
Oslo, 0027, Norway
NO002
Trondheim, 7006, Norway
ZA003
Cape Town, 7130, South Africa
ZA002
Cape Town, 7405, South Africa
ZA001
Cape Town, 7800, South Africa
SE002
Lund, 221 85, Sweden
SE001
Malmo, 205 02, Sweden
GB012
Belfast, BT12 6BJ, United Kingdom
GB004
Christchurch, BH23 2JX, United Kingdom
GB010
Dundee, DD1 9SY, United Kingdom
GB002
Exeter, EX2 5DW, United Kingdom
GB009
Glasgow, G11 6NT, United Kingdom
GB007
Glasgow, G51 4TF, United Kingdom
GB011
Liverpool, L7 8XP, United Kingdom
GB006
London, SE5 8AF, United Kingdom
GB003
London, SW17 0RE, United Kingdom
GB001
Newcastle upon Tyne, NE1 4LP, United Kingdom
GB016
Nottingham, NG5 1PB, United Kingdom
GB014
Sheffield, S10 2JF, United Kingdom
GB005
Stoke-on-Trent, ST4 6QG, United Kingdom
GB015
Westcliff-on-Sea, SS0 0RY, United Kingdom
GB013
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
von Kummer R, Mori E, Truelsen T, Jensen JS, Gronning BA, Fiebach JB, Lovblad KO, Pedraza S, Romero JM, Chabriat H, Chang KC, Davalos A, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A, Albers GW; DIAS-4 Investigators. Desmoteplase 3 to 9 Hours After Major Artery Occlusion Stroke: The DIAS-4 Trial (Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke). Stroke. 2016 Dec;47(12):2880-2887. doi: 10.1161/STROKEAHA.116.013715. Epub 2016 Nov 1.
PMID: 27803391DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- study director
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2014
Last Updated
March 16, 2017
Results First Posted
December 22, 2015
Record last verified: 2017-02