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StrokePhase 3NCT00856661

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

A Phase 3 study testing Desmoteplase in people with Stroke, run by H. Lundbeck A/S at 152 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Desmoteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
152 sitesin 14 countries
Study dates
Apr 2009to Oct 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

152 sites in 14 countries.

152 sites in 14 countries

United States81 sites

  • US075

    Albany, New York, 12208

  • US070

    Allentown, Pennsylvania, 18103

  • US109

    Atlanta, Georgia, 30303

  • US042

    Augusta, Georgia, 30912

  • US014

    Baltimore, Maryland, 21231

  • US039

    Boston, Massachusetts, 02114

  • US003

    Boston, Massachusetts, 02118

  • US102

    Brooklyn, New York, 11220

  • US012

    Buffalo, New York, 14203

  • US081

    Castro Valley, California, 94546

  • US019

    Chattanooga, Tennessee, 37403

  • US093

    Chicago, Illinois, 60611

  • US101

    Chicago, Illinois, 60612

  • US044

    Chicago, Illinois, 60622

  • US038

    Cleveland, Ohio, 44109

  • US057

    Columbia, South Carolina, 29203

  • US052

    Columbus, Georgia, 31902

  • US001

    Columbus, Ohio, 43210

  • US062

    Columbus, Ohio, 43214

  • US080

    Decatur, Georgia, 30033

  • US072

    Des Moines, Iowa, 50314-2611

  • US066

    Detroit, Michigan, 48201

  • US096

    Detroit, Michigan, 48202

  • US083

    Detroit, Michigan, 48236

  • US055

    Edison, New Jersey, 08818

  • US068

    Englewood, Colorado, 80113

  • US074

    Evanston, Illinois, 60201

  • US063

    Fairfield, Connecticut, 06824

  • US073

    Glenview, Illinois, 60026

  • US060

    Grand Blanc, Michigan, 48439

  • US078

    Grand Rapids, Michigan, 49503

  • US037

    Greensboro, North Carolina, 27401

  • US059

    Gulfport, Mississippi, 39502

  • US021

    Houston, Texas, 77030

  • US031

    Houston, Texas, 77030

  • US112

    Houston, Texas, 77030

  • US016

    Indianapolis, Indiana, 46260

  • US103

    Kalamazoo, Michigan, 49007

  • US089

    La Jolla, California, 92037

  • US040

    Lawrenceville, Georgia, 30045

  • US077

    Lebanon, New Hampshire, 03756

  • US043

    Loma Linda, California, 92354

  • US008

    Los Angeles, California, 90024-1777

  • US067

    Macon, Georgia, 31201

  • US011

    Madison, Wisconsin, 53792

  • US091

    Maywood, Illinois, 60153

  • US097

    Milwaukee, Wisconsin, 53226

  • US058

    Nashville, Tennessee, 37205

  • US115

    Neptune City, New Jersey, 07753

  • US104

    New Haven, Connecticut, 06510

  • US061

    New Orleans, Louisiana, 70112

  • US108

    New Orleans, Louisiana, 70121

  • US088

    Oak Lawn, Illinois, 60453

  • US020

    Palo Alto, California, 94304

  • US050

    Pasadena, California, 91105

  • US049

    Pensacola, Florida, 32504

  • US056

    Petoskey, Michigan, 49770

  • US023

    Philadelphia, Pennsylvania, 19141

  • US053

    Phoenix, Arizona, 85054

  • US099

    Pittsburgh, Pennsylvania, 15212

  • US084

    Pittsburgh, Pennsylvania, 15213

  • US092

    Providence, Rhode Island, 02903

  • US047

    Richmond, Virginia, 23298

  • US100

    Ridgewood, New Jersey, 07450

  • US113

    Royal Oak, Michigan, 48073

  • US098

    Santa Barbara, California, 93105

  • US085

    Savannah, Georgia, 31405

  • US086

    Savannah, Georgia, 31419

  • US064

    Shreveport, Louisiana, 71130-3932

  • US076

    Southfield, Michigan, 48075

  • US082

    Southfield, Michigan, 48075

  • US048

    Springfield, Missouri, 65807

  • US095

    Springfield, Oregon, 97477

  • US026

    Stony Brook, New York, 11794-8121

  • US051

    Thousand Oaks, California, 91360

  • US046

    Toledo, Ohio, 43614

  • US079

    Troy, Michigan, 48085

  • US087

    Warwick, Rhode Island, 02886

  • US006

    Winchester, Virginia, 22601

  • US069

    Winston-Salem, North Carolina, 27157

  • US017

    Worcester, Massachusetts, 01605

Other trials in United States

United Kingdom15 sites

  • GB012

    Belfast, BT12 6BJ

  • GB004

    Christchurch, BH23 2JX

  • GB010

    Dundee, DD1 9SY

  • GB002

    Exeter, EX2 5DW

  • GB009

    Glasgow, G11 6NT

  • GB007

    Glasgow, G51 4TF

  • GB011

    Liverpool, L7 8XP

  • GB006

    London, SE5 8AF

  • GB003

    London, SW17 0RE

  • GB001

    Newcastle upon Tyne, NE1 4LP

  • GB016

    Nottingham, NG5 1PB

  • GB014

    Sheffield, S10 2JF

  • GB005

    Stoke-on-Trent, ST4 6QG

  • GB015

    Westcliff-on-Sea, SS0 0RY

  • GB013

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Italy12 sites

  • IT010

    Ancona, 60020

  • IT008

    Brescia, 25123

  • IT003

    Florence, 50019

  • IT004

    Imperia, 18100

  • IT002

    Milan, 20132

  • IT006

    Milan, 20153

  • IT009

    Milan, 20162

  • IT012

    Modena, 41100

  • IT001

    Rome, 161

  • IT005

    Rome, 189

  • IT007

    Rozzano, 20089

  • IT011

    Verona, 37126

Other trials in Italy

Canada8 sites

  • CA001

    Calgary, Alberta, T2N 2T9

  • CA004

    Edmonton, T6L 5X8

  • CA006

    Halifax, B3H 3A7

  • CA008

    Mississauga, L5B 1B8

  • CA007

    Ottawa, K1Y 4E9

  • CA012

    Toronto, M4N 3M5

  • CA002

    Toronto, M5T 2S8

  • CA005

    Victoria, V8R 1J8

Other trials in Canada

Brazil7 sites

  • BR012

    Campinas, 13083-970

  • BR004

    Porto Alegre, 90020-090

  • BR008

    Porto Alegre, 90035-003

  • BR007

    Porto Alegre, 90110-270

  • BR009

    Rio de Janeiro, 20941-150

  • BR011

    Rio de Janeiro, 22280-000

  • BR006

    Salvador, 40140-110

Other trials in Brazil

Chile5 sites

  • CL002

    Santiago

  • CL003

    Santiago

  • CL004

    Santiago

  • CL006

    Santiago

  • CL005

    Valparaíso

Other trials in Chile

Belgium4 sites

  • BE008

    Bruges, 8000

  • BE004

    Hasselt, 3500

  • BE005

    Roeselare, 8800

  • BE006

    Wilrijk, 2610

Other trials in Belgium

Denmark4 sites

  • DK002

    Aalborg, 9000

  • DK001

    Aarhus, 8000

  • DK004

    Copenhagen NV, 2400

  • DK003

    Glostrup Municipality, 2600

Other trials in Denmark

Mexico4 sites

  • MX002

    D.f., 14269

  • MX003

    Mexico City, 14000

  • MX004

    Mexico City, 14050

  • MX005

    Monterrey Nuevo Leon

Other trials in Mexico

Finland3 sites

  • FI001

    Helsinki, 29

  • FI002

    Tampere, 33520

  • FI003

    Turku, 20520

Other trials in Finland

Norway3 sites

  • NO003

    Bergen, 2021

  • NO001

    Oslo, 0027

  • NO002

    Trondheim, 7006

Other trials in Norway

South Africa3 sites

  • ZA003

    Cape Town, 7130

  • ZA002

    Cape Town, 7405

  • ZA001

    Cape Town, 7800

Other trials in South Africa

Sweden2 sites

  • SE002

    Lund, 221 85

  • SE001

    Malmö, 205 02

Other trials in Sweden

Ireland1 site

  • IE001

    Dublin, 8

Other trials in Ireland

About this 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

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.

Read the 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.

Conditions
Stroke
Being tested
Desmoteplase, Placebo
Keywords
Acute ischemic stroke, Angiography, Desmoteplase, Thrombolytic
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DesmoteplaseDrug

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

  • PlaceboDrug

    IV, single bolus over 1 to 2 minutes on 1st day

Study groups in NCT00856661
Study groupRoleWhat they receive
DesmoteplaseExperimentalNot described
Receives: Drug: Desmoteplase
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 90

Secondary outcomes (3)

  1. National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)

    The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.

    Measured: 90 days

  2. Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)

    Please see outcomes measure one and two for detailed description of the scales

    Measured: Day 90

  3. Modified Ranking Scale Score (Using the Ordinal Scale)

    Please see outcomes measure one for detailed description of the mRS scale

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionOct 2014

Why it 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856661
Sponsor's protocol ID
12649A
Other IDs
2008-005539-14, 2008
Status last verified
Feb 2017
First submitted
5 Mar 2009
Last updated
16 Mar 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27803391

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Desmoteplase in people with Stroke, run by H. Lundbeck A/S at 152 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, United Kingdom, Italy, Canada, Brazil and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2) (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00856661, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.

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