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

NCT ID: NCT00856661

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Desmoteplase

Group Type: EXPERIMENTAL

Desmoteplase

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Desmoteplase

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@lundbeck.com

Locations

US053

Phoenix, Arizona, United States

US081

Castro Valley, California, United States

US089

La Jolla, California, United States

US043

Loma Linda, California, United States

US008

Los Angeles, California, United States

US020

Palo Alto, California, United States

US050

Pasadena, California, United States

US098

Santa Barbara, California, United States

US051

Thousand Oaks, California, United States

US068

Englewood, Colorado, United States

US063

Fairfield, Connecticut, United States

US104

New Haven, Connecticut, United States

US049

Pensacola, Florida, United States

US109

Atlanta, Georgia, United States

US042

Augusta, Georgia, United States

US052

Columbus, Georgia, United States

US080

Decatur, Georgia, United States

US040

Lawrenceville, Georgia, United States

US067

Macon, Georgia, United States

US085

Savannah, Georgia, United States

US086

Savannah, Georgia, United States

US093

Chicago, Illinois, United States

US101

Chicago, Illinois, United States

US044

Chicago, Illinois, United States

US074

Evanston, Illinois, United States

US073

Glenview, Illinois, United States

US091

Maywood, Illinois, United States

US088

Oak Lawn, Illinois, United States

US016

Indianapolis, Indiana, United States

US072

Des Moines, Iowa, United States

US061

New Orleans, Louisiana, United States

US108

New Orleans, Louisiana, United States

US064

Shreveport, Louisiana, United States

US014

Baltimore, Maryland, United States

US039

Boston, Massachusetts, United States

US003

Boston, Massachusetts, United States

US017

Worcester, Massachusetts, United States

US066

Detroit, Michigan, United States

US096

Detroit, Michigan, United States

US083

Detroit, Michigan, United States

US060

Grand Blanc, Michigan, United States

US078

Grand Rapids, Michigan, United States

US103

Kalamazoo, Michigan, United States

US056

Petoskey, Michigan, United States

US113

Royal Oak, Michigan, United States

US076

Southfield, Michigan, United States

US082

Southfield, Michigan, United States

US079

Troy, Michigan, United States

US059

Gulfport, Mississippi, United States

US048

Springfield, Missouri, United States

US077

Lebanon, New Hampshire, United States

US055

Edison, New Jersey, United States

US115

Neptune City, New Jersey, United States

US100

Ridgewood, New Jersey, United States

US075

Albany, New York, United States

US102

Brooklyn, New York, United States

US012

Buffalo, New York, United States

US026

Stony Brook, New York, United States

US037

Greensboro, North Carolina, United States

US069

Winston-Salem, North Carolina, United States

US038

Cleveland, Ohio, United States

US001

Columbus, Ohio, United States

US062

Columbus, Ohio, United States

US046

Toledo, Ohio, United States

US095

Springfield, Oregon, United States

US070

Allentown, Pennsylvania, United States

US023

Philadelphia, Pennsylvania, United States

US099

Pittsburgh, Pennsylvania, United States

US084

Pittsburgh, Pennsylvania, United States

US092

Providence, Rhode Island, United States

US087

Warwick, Rhode Island, United States

US057

Columbia, South Carolina, United States

US019

Chattanooga, Tennessee, United States

US058

Nashville, Tennessee, United States

US021

Houston, Texas, United States

US031

Houston, Texas, United States

US112

Houston, Texas, United States

US047

Richmond, Virginia, United States

US006

Winchester, Virginia, United States

US011

Madison, Wisconsin, United States

US097

Milwaukee, Wisconsin, United States

BE008

Bruges, , Belgium

BE004

Hasselt, , Belgium

BE005

Roeselare, , Belgium

BE006

Wilrijk, , Belgium

BR012

Campinas, , Brazil

BR004

Porto Alegre, , Brazil

BR008

Porto Alegre, , Brazil

BR007

Porto Alegre, , Brazil

BR009

Rio de Janeiro, , Brazil

BR011

Rio de Janeiro, , Brazil

BR006

Salvador, , Brazil

CA001

Calgary, Alberta, Canada

CA004

Edmonton, , Canada

CA006

Halifax, , Canada

CA008

Mississauga, , Canada

CA007

Ottawa, , Canada

CA012

Toronto, , Canada

CA002

Toronto, , Canada

CA005

Victoria, , Canada

CL002

Santiago, , Chile

CL003

Santiago, , Chile

CL004

Santiago, , Chile

CL006

Santiago, , Chile

CL005

Valparaíso, , Chile

DK002

Aalborg, , Denmark

DK001

Aarhus, , Denmark

DK004

Copenhagen NV, , Denmark

DK003

Glostrup Municipality, , Denmark

FI001

Helsinki, , Finland

FI002

Tampere, , Finland

FI003

Turku, , Finland

IE001

Dublin, , Ireland

IT010

Ancona, , Italy

IT008

Brescia, , Italy

IT003

Florence, , Italy

IT004

Imperia, , Italy

IT002

Milan, , Italy

IT006

Milan, , Italy

IT009

Milan, , Italy

IT012

Modena, , Italy

IT001

Rome, , Italy

IT005

Rome, , Italy

IT007

Rozzano, , Italy

IT011

Verona, , Italy

MX002

D.f., , Mexico

MX003

Mexico City, , Mexico

MX004

Mexico City, , Mexico

MX005

Monterrey Nuevo Leon, , Mexico

NO003

Bergen, , Norway

NO001

Oslo, , Norway

NO002

Trondheim, , Norway

ZA003

Cape Town, , South Africa

ZA002

Cape Town, , South Africa

ZA001

Cape Town, , South Africa

SE002

Lund, , Sweden

SE001

Malmo, , Sweden

GB012

Belfast, , United Kingdom

GB004

Christchurch, , United Kingdom

GB010

Dundee, , United Kingdom

GB002

Exeter, , United Kingdom

GB009

Glasgow, , United Kingdom

GB007

Glasgow, , United Kingdom

GB011

Liverpool, , United Kingdom

GB006

London, , United Kingdom

GB003

London, , United Kingdom

GB001

Newcastle upon Tyne, , United Kingdom

GB016

Nottingham, , United Kingdom

GB014

Sheffield, , United Kingdom

GB005

Stoke-on-Trent, , United Kingdom

GB015

Westcliff-on-Sea, , United Kingdom

GB013

Wolverhampton, , United Kingdom

Countries

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

References

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.

Reference Type: DERIVED

PMID: 27803391 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-005539-14/results

EMA EudraCT Results: 2008-005539-14

Other Identifiers

2008-005539-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12649A

Identifier Type: -

Identifier Source: org_study_id