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 3-9 hours from onset of stroke symptoms.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

492

participants targeted

Target at P50-P75 for phase_3 stroke

Geographic Reach

15 countries

93 active sites

Status

completed

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

November 13, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed

17 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed

5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed

Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

5.6 years

First QC Date

November 13, 2008

Last Update Submit

September 17, 2015

Conditions

Stroke

Keywords

Acute ischemic strokeAngiographyDesmoteplaseThrombolytic

Outcome Measures

Primary Outcomes (1)

Modified Rankin Scale Score
90 days

Secondary Outcomes (1)

National Institutes of Health Stroke Scale (NIHSS) Score
90 days

Study Arms (2)

Desmoteplase

EXPERIMENTAL

Drug: Desmoteplase

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DesmoteplaseDRUG

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

Desmoteplase

PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

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 (102)

AU006

Clayton, 3168, Australia

Location

AU004

Gosford, 2250, Australia

Location

AU001

Melbourne, Australia

Location

AU002

Melbourne, Australia

Location

AU003

Newcastle, Australia

Location

AU009

Perth, 6000, Australia

Location

AT003

Graz, 8036, Austria

Location

AT004

Innsbruck, 6020, Austria

Location

AT002

Linz, 4020, Austria

Location

AT001

Linz, 4021, Austria

Location

AT005

Vienna, 1090, Austria

Location

EE002

Tallinn, 10138, Estonia

Location

EE004

Tallinn, 10617, Estonia

Location

EE003

Tallinn, 13419, Estonia

Location

EE001

Tartu, 51014, Estonia

Location

FR004

Besançon, 25000, France

Location

FR013

Bordeaux, 33076, France

Location

FR003

Bourg-en-Bresse, 1012, France

Location

FR015

Caen, 14033, France

Location

FR014

Lille, 59037, France

Location

FR012

Limoges, 87042, France

Location

FR008

Montpellier, 34295, France

Location

FR010

Nice, 6000, France

Location

FR001

Paris, 75010, France

Location

FR009

Paris, 75014, France

Location

FR007

Perpignan, 66046, France

Location

FR016

Toulouse, 31059, France

Location

DE002

Berlin, 12200, Germany

Location

DE001

Dresden, 1307, Germany

Location

DE011

Erlangen, 91054, Germany

Location

DE005

Freiburg im Breisgau, 79104, Germany

Location

DE018

Hamburg, 20246, Germany

Location

DE020

Hanover, 30625, Germany

Location

DE019

Jena, 7747, Germany

Location

DE003

Leipzig, 4103, Germany

Location

DE022

Lübeck, Germany

Location

DE021

Neuruppin, 16816, Germany

Location

DE025

Rostock, 18147, Germany

Location

DE012

Schweinfurt, 97422, Germany

Location

DE016

Würzburg, 97080, Germany

Location

HK001

Hong Kong, Hong Kong

Location

HK002

Hong Kong, Hong Kong

Location

IN004

Chandigarh, 160012, India

Location

IN009

Guntur, 522001, India

Location

IN008

Hyderabad, 500001, India

Location

IN003

Hyderabad, 500082, India

Location

IN007

Ludhiana, 141008, India

Location

IN001

Pune, 411001, India

Location

NL001

Breda, 4818 CK, Netherlands

Location

NL002

Groningen, 9713 GZ, Netherlands

Location

PH003

Manila, Philippines

Location

PH001

Pasig, Philippines

Location

PH002

Quezon City, Philippines

Location

PL004

Gdansk, 80952, Poland

Location

PL005

Lublin, 29950, Poland

Location

PL006

Sandomierz, 27600, Poland

Location

PL001

Warsaw, 02-957, Poland

Location

PL002

Warsaw, 02-957, Poland

Location

SG002

Singapore, 169608, Singapore

Location

SG001

Singapore, Singapore

Location

KR013

Ansan-si, 425 707, South Korea

Location

KR003

Anyang, 431 070, South Korea

Location

KR006

Busan, 602-715, South Korea

Location

KR011

Daegu, South Korea

Location

KR002

Incheon, 400-711, South Korea

Location

KR010

Kwangju, 501757, South Korea

Location

KR008

Seongnam, 463-707, South Korea

Location

KR004

Seoul, 120-752, South Korea

Location

KR001

Seoul, 137-710, South Korea

Location

KR012

Seoul, 139711, South Korea

Location

KR009

Seoul, 156707, South Korea

Location

KR005

Seoul, South Korea

Location

KR007

Wŏnju, 220-701, South Korea

Location

ES010

Albacete, 2006, Spain

Location

ES012

Alcázar de San Juan, 13600, Spain

Location

ES007

Barcelona, 8907, Spain

Location

ES003

Barcelona, 8916, Spain

Location

ES014

Bilbao, 48013, Spain

Location

ES004

Girona, 17007, Spain

Location

ES013

Lugo, 27003, Spain

Location

ES011

Madrid, 28034, Spain

Location

ES005

Madrid, 28040, Spain

Location

ES008

Madrid, 75010, Spain

Location

ES006

Valladolid, 47005, Spain

Location

CH001

Lausanne, 1011, Switzerland

Location

TW003

Kaohsiung City, 807, Taiwan

Location

TW001

Kaohsiung City, 833, Taiwan

Location

TW006

Taichung, 40447, Taiwan

Location

TW005

Tainan, 704, Taiwan

Location

TW008

Tainan, 710, Taiwan

Location

TW009

Taipei, 100, Taiwan

Location

TW007

Taipei, 10449, Taiwan

Location

TW002

Taipei, Taiwan

Location

TW004

Taoyuan District, 333, Taiwan

Location

TH003

Bangkok, 10330, Thailand

Location

TH002

Bangkok, 10400, Thailand

Location

TH006

Bangkok, 10400, Thailand

Location

TH004

Bangkok, 10700, Thailand

Location

TH005

Chiang Mai, 50200, Thailand

Location

TH001

Pathum Thani, 12120, Thailand

Location

VN002

Hanoi, Vietnam

Location

VN001

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Gronning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.
PMID: 25937443DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

salivary plasminogen activator alpha 1, Desmodus rotundus

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
STUDY DIRECTOR

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

November 13, 2008

First Posted

November 14, 2008

Study Start

December 1, 2008

Primary Completion

July 1, 2014

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

FR(12)CH(1)TH(6)AU(6)VN(2)PL(5)HK(2)KR(13)NL(2)SG(2)ES(11)TW(9)PH(3)IN(6)DE(13)

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Desmoteplase

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (102)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Desmoteplase

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (102)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations