Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

Stroke Clinical Trial

— DIAS-3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790920
• Other study ID #: 12402A
• Secondary ID: 2008-000622-40
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2008
• Last updated: September 17, 2015
• Start date: December 2008

Study information

• Verified date: September 2015
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Agency for Health and Food SafetyEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHong Kong: Department of HealthHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaKorea: Food and Drug AdministrationNetherlands: Ministry of Health, Welfare and SportPhilippines: Bureau of Food and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSingapore: Health Sciences AuthoritySpain: Spanish Agency of MedicinesSwitzerland: SwissmedicTaiwan: National Bureau of Controlled DrugsThailand: Food and Drug AdministrationVietnam: Ministry of Health
• Study type: Interventional

Clinical 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 3-9 hours from onset of stroke symptoms.

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 3-9 hours after onset of stroke symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Desmoteplase
90 µg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
• Placebo
IV, single bolus over 1 - 2 minutes on 1st day

Locations

Country	Name	City	State
Australia	AU006	Clayton
Australia	AU004	Gosford
Australia	AU001	Melbourne
Australia	AU002	Melbourne
Australia	AU003	New Castle
Australia	AU009	Perth
Austria	AT003	Graz
Austria	AT004	Innsbruck
Austria	AT001	Linz
Austria	AT002	Linz
Austria	AT005	Vienna
Estonia	EE002	Tallinn
Estonia	EE003	Tallinn
Estonia	EE004	Tallinn
Estonia	EE001	Tartu
France	FR004	Besancon
France	FR013	Bordeaux
France	FR003	Bourg-en-Bresse
France	FR015	Caen
France	FR014	Lille
France	FR012	Limoges
France	FR008	Montpellier
France	FR010	Nice
France	FR001	Paris
France	FR009	Paris
France	FR007	Perpignan
France	FR016	Toulouse
Germany	DE002	Berlin
Germany	DE001	Dresden
Germany	DE011	Erlangen
Germany	DE005	Freiburg
Germany	DE018	Hamburg
Germany	DE020	Hannover
Germany	DE019	Jena
Germany	DE003	Leipzig
Germany	DE022	Lübeck
Germany	DE021	Neuruppin
Germany	DE025	Rostock
Germany	DE012	Schweinfurt
Germany	DE016	Wurzburg
Hong Kong	HK001	Hong Kong
Hong Kong	HK002	Hong Kong
India	IN004	Chandigarh
India	IN009	Guntur
India	IN003	Hyderabad
India	IN008	Hyderabad
India	IN007	Ludhiana
India	IN001	Pune
Korea, Republic of	KR013	Ansan-Si
Korea, Republic of	KR003	Anyang City
Korea, Republic of	KR006	Busan
Korea, Republic of	KR011	Daegu
Korea, Republic of	KR002	In Cheon
Korea, Republic of	KR010	Kwangju
Korea, Republic of	KR008	Seongnam
Korea, Republic of	KR001	Seoul
Korea, Republic of	KR004	Seoul
Korea, Republic of	KR005	Seoul
Korea, Republic of	KR009	Seoul
Korea, Republic of	KR012	Seoul
Korea, Republic of	KR007	Wonju-si
Netherlands	NL001	Breda
Netherlands	NL002	Groningen
Philippines	PH003	Manila
Philippines	PH001	Pasig City
Philippines	PH002	Quezon City
Poland	PL004	Gdansk
Poland	PL005	Lublin
Poland	PL006	Sandomierz
Poland	PL001	Warszawa
Poland	PL002	Warszawa
Singapore	SG001	Singapore
Singapore	SG002	Singapore
Spain	ES010	Albacete
Spain	ES012	Alcazar de San Juan
Spain	ES003	Barcelona
Spain	ES007	Barcelona
Spain	ES014	Bilbao
Spain	ES004	Girona
Spain	ES013	Lugo
Spain	ES005	Madrid
Spain	ES008	Madrid
Spain	ES011	Madrid
Spain	ES006	Valladolid
Switzerland	CH001	Lausanne
Taiwan	TW001	Kaohsiung
Taiwan	TW003	Kaohsiung
Taiwan	TW006	Taichung
Taiwan	TW005	Tainan
Taiwan	TW008	Tainan
Taiwan	TW002	Taipei
Taiwan	TW007	Taipei
Taiwan	TW009	Taipei
Taiwan	TW004	Taoyuan
Thailand	TH002	Bangkok
Thailand	TH003	Bangkok
Thailand	TH004	Bangkok
Thailand	TH006	Bangkok
Thailand	TH005	Chiang Mai
Thailand	TH001	Pathumthani
Vietnam	VN002	Hanoi
Vietnam	VN001	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

Australia,  Austria,  Estonia,  France,  Germany,  Hong Kong,  India,  Korea, Republic of,  Netherlands,  Philippines,  Poland,  Singapore,  Spain,  Switzerland,  Taiwan,  Thailand,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale Score		90 days	No
Secondary	National Institutes of Health Stroke Scale (NIHSS) Score		90 days	No

External Links

•   EMA EudraCT Result Posting
•   The Lancet Neurology