DIAS-3: Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00790920

Collaborator

(none)

492

Enrollment

102

Locations

Arms

4.8

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Desmoteplase Drug: Placebo	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

492 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desmoteplase	Drug: Desmoteplase 90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
Placebo Comparator: Placebo	Drug: Placebo IV, single bolus over 1 - 2 minutes on 1st day

Arm

Intervention/Treatment

Experimental: Desmoteplase

Drug: Desmoteplase

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

Placebo Comparator: Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale Score [90 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	AU006	Clayton	Australia	3168
2	AU004	Gosford	Australia	2250
3	AU001	Melbourne	Australia
4	AU002	Melbourne	Australia
5	AU003	New Castle	Australia
6	AU009	Perth	Australia	6000
7	AT003	Graz	Austria	8036
8	AT004	Innsbruck	Austria	6020
9	AT002	Linz	Austria	4020
10	AT001	Linz	Austria	4021
11	AT005	Vienna	Austria	1090
12	EE002	Tallinn	Estonia	10138
13	EE004	Tallinn	Estonia	10617
14	EE003	Tallinn	Estonia	13419
15	EE001	Tartu	Estonia	51014
16	FR004	Besancon	France	25000
17	FR013	Bordeaux	France	33076
18	FR003	Bourg-en-Bresse	France	1012
19	FR015	Caen	France	14033
20	FR014	Lille	France	59037
21	FR012	Limoges	France	87042
22	FR008	Montpellier	France	34295
23	FR010	Nice	France	6000
24	FR001	Paris	France	75010
25	FR009	Paris	France	75014
26	FR007	Perpignan	France	66046
27	FR016	Toulouse	France	31059
28	DE002	Berlin	Germany	12200
29	DE001	Dresden	Germany	1307
30	DE011	Erlangen	Germany	91054
31	DE005	Freiburg	Germany	79104
32	DE018	Hamburg	Germany	20246
33	DE020	Hannover	Germany	30625
34	DE019	Jena	Germany	7747
35	DE003	Leipzig	Germany	4103
36	DE022	Lübeck	Germany
37	DE021	Neuruppin	Germany	16816
38	DE025	Rostock	Germany	18147
39	DE012	Schweinfurt	Germany	97422
40	DE016	Wurzburg	Germany	97080
41	HK001	Hong Kong	Hong Kong
42	HK002	Hong Kong	Hong Kong
43	IN004	Chandigarh	India	160012
44	IN009	Guntur	India	522001
45	IN008	Hyderabad	India	500001
46	IN003	Hyderabad	India	500082
47	IN007	Ludhiana	India	141008
48	IN001	Pune	India	411001
49	KR013	Ansan-Si	Korea, Republic of	425 707
50	KR003	Anyang City	Korea, Republic of	431 070
51	KR006	Busan	Korea, Republic of	602-715
52	KR011	Daegu	Korea, Republic of
53	KR002	In Cheon	Korea, Republic of	400-711
54	KR010	Kwangju	Korea, Republic of	501757
55	KR008	Seongnam	Korea, Republic of	463-707
56	KR004	Seoul	Korea, Republic of	120-752
57	KR001	Seoul	Korea, Republic of	137-710
58	KR012	Seoul	Korea, Republic of	139711
59	KR009	Seoul	Korea, Republic of	156707
60	KR005	Seoul	Korea, Republic of
61	KR007	Wonju-si	Korea, Republic of	220-701
62	NL001	Breda	Netherlands	4818 CK
63	NL002	Groningen	Netherlands	9713 GZ
64	PH003	Manila	Philippines
65	PH001	Pasig City	Philippines
66	PH002	Quezon City	Philippines
67	PL004	Gdansk	Poland	80952
68	PL005	Lublin	Poland	29950
69	PL006	Sandomierz	Poland	27600
70	PL001	Warszawa	Poland	02-957
71	PL002	Warszawa	Poland	02-957
72	SG002	Singapore	Singapore	169608
73	SG001	Singapore	Singapore
74	ES010	Albacete	Spain	2006
75	ES012	Alcazar de San Juan	Spain	13600
76	ES007	Barcelona	Spain	8907
77	ES003	Barcelona	Spain	8916
78	ES014	Bilbao	Spain	48013
79	ES004	Girona	Spain	17007
80	ES013	Lugo	Spain	27003
81	ES011	Madrid	Spain	28034
82	ES005	Madrid	Spain	28040
83	ES008	Madrid	Spain	75010
84	ES006	Valladolid	Spain	47005
85	CH001	Lausanne	Switzerland	1011
86	TW003	Kaohsiung	Taiwan	807
87	TW001	Kaohsiung	Taiwan	833
88	TW006	Taichung	Taiwan	40447
89	TW005	Tainan	Taiwan	704
90	TW008	Tainan	Taiwan	710
91	TW009	Taipei	Taiwan	100
92	TW007	Taipei	Taiwan	10449
93	TW002	Taipei	Taiwan
94	TW004	Taoyuan	Taiwan	333
95	TH003	Bangkok	Thailand	10330
96	TH002	Bangkok	Thailand	10400
97	TH006	Bangkok	Thailand	10400
98	TH004	Bangkok	Thailand	10700
99	TH005	Chiang Mai	Thailand	50200
100	TH001	Pathumthani	Thailand	12120
101	VN002	Hanoi	Vietnam
102	VN001	Ho Chi Minh City	Vietnam