Clinical trial NCT00790920: Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: Acute ischemic stroke
Angiography
Desmoteplase
Thrombolytic
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 3-9 hours after onset of stroke symptoms.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Rankin Scale Score
timeFrame: 90 days
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) Score
timeFrame: 90 days
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: AU006
city: Gosford
country: Australia
facility: AU004
city: Melbourne
country: Australia
facility: AU001
city: Melbourne
country: Australia
facility: AU002
city: New Castle
country: Australia
facility: AU003
city: Perth
country: Australia
facility: AU009
city: Graz
country: Austria
facility: AT003
city: Innsbruck
country: Austria
facility: AT004
city: Linz
country: Austria
facility: AT002
city: Linz
country: Austria
facility: AT001
city: Vienna
country: Austria
facility: AT005
city: Tallinn
country: Estonia
facility: EE002
city: Tallinn
country: Estonia
facility: EE004
city: Tallinn
country: Estonia
facility: EE003
city: Tartu
country: Estonia
facility: EE001
city: Besancon
country: France
facility: FR004
city: Bordeaux
country: France
facility: FR013
city: Bourg-en-Bresse
country: France
facility: FR003
city: Caen
country: France
facility: FR015
city: Lille
country: France
facility: FR014
city: Limoges
country: France
facility: FR012
city: Montpellier
country: France
facility: FR008
city: Nice
country: France
facility: FR010
city: Paris
country: France
facility: FR001
city: Paris
country: France
facility: FR009
city: Perpignan
country: France
facility: FR007
city: Toulouse
country: France
facility: FR016
city: Berlin
country: Germany
facility: DE002
city: Dresden
country: Germany
facility: DE001
city: Erlangen
country: Germany
facility: DE011
city: Freiburg
country: Germany
facility: DE005
city: Hamburg
country: Germany
facility: DE018
city: Hannover
country: Germany
facility: DE020
city: Jena
country: Germany
facility: DE019
city: Leipzig
country: Germany
facility: DE003
city: Lübeck
country: Germany
facility: DE022
city: Neuruppin
country: Germany
facility: DE021
city: Rostock
country: Germany
facility: DE025
city: Schweinfurt
country: Germany
facility: DE012
city: Wurzburg
country: Germany
facility: DE016
city: Hong Kong
country: Hong Kong
facility: HK001
city: Hong Kong
country: Hong Kong
facility: HK002
city: Chandigarh
country: India
facility: IN004
city: Guntur
country: India
facility: IN009
city: Hyderabad
country: India
facility: IN008
city: Hyderabad
country: India
facility: IN003
city: Ludhiana
country: India
facility: IN007
city: Pune
country: India
facility: IN001
city: Ansan-Si
country: Korea, Republic of
facility: KR013
city: Anyang City
country: Korea, Republic of
facility: KR003
city: Busan
country: Korea, Republic of
facility: KR006
city: Daegu
country: Korea, Republic of
facility: KR011
city: In Cheon
country: Korea, Republic of
facility: KR002
city: Kwangju
country: Korea, Republic of
facility: KR010
city: Seongnam
country: Korea, Republic of
facility: KR008
city: Seoul
country: Korea, Republic of
facility: KR004
city: Seoul
country: Korea, Republic of
facility: KR001
city: Seoul
country: Korea, Republic of
facility: KR012
city: Seoul
country: Korea, Republic of
facility: KR009
city: Seoul
country: Korea, Republic of
facility: KR005
city: Wonju-si
country: Korea, Republic of
facility: KR007
city: Breda
country: Netherlands
facility: NL001
city: Groningen
country: Netherlands
facility: NL002
city: Manila
country: Philippines
facility: PH003
city: Pasig City
country: Philippines
facility: PH001
city: Quezon City
country: Philippines
facility: PH002
city: Gdansk
country: Poland
facility: PL004
city: Lublin
country: Poland
facility: PL005
city: Sandomierz
country: Poland
facility: PL006
city: Warszawa
country: Poland
facility: PL001
city: Warszawa
country: Poland
facility: PL002
city: Singapore
country: Singapore
facility: SG002
city: Singapore
country: Singapore
facility: SG001
city: Albacete
country: Spain
facility: ES010
city: Alcazar de San Juan
country: Spain
facility: ES012
city: Barcelona
country: Spain
facility: ES007
city: Barcelona
country: Spain
facility: ES003
city: Bilbao
country: Spain
facility: ES014
city: Girona
country: Spain
facility: ES004
city: Lugo
country: Spain
facility: ES013
city: Madrid
country: Spain
facility: ES011
city: Madrid
country: Spain
facility: ES005
city: Madrid
country: Spain
facility: ES008
city: Valladolid
country: Spain
facility: ES006
city: Lausanne
country: Switzerland
facility: CH001
city: Kaohsiung
country: Taiwan
facility: TW003
city: Kaohsiung
country: Taiwan
facility: TW001
city: Taichung
country: Taiwan
facility: TW006
city: Tainan
country: Taiwan
facility: TW005
city: Tainan
country: Taiwan
facility: TW008
city: Taipei
country: Taiwan
facility: TW009
city: Taipei
country: Taiwan
facility: TW007
city: Taipei
country: Taiwan
facility: TW002
city: Taoyuan
country: Taiwan
facility: TW004
city: Bangkok
country: Thailand
facility: TH003
city: Bangkok
country: Thailand
facility: TH002
city: Bangkok
country: Thailand
facility: TH006
city: Bangkok
country: Thailand
facility: TH004
city: Chiang Mai
country: Thailand
facility: TH005
city: Pathumthani
country: Thailand
facility: TH001
city: Hanoi
country: Vietnam
facility: VN002
city: Ho Chi Minh City
country: Vietnam
facility: VN001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.