Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

Sponsor

Neurobiological Technologies (Industry)

Overall Status

Terminated

CT.gov ID

NCT00141011

Collaborator

(none)

277

Enrollment

100

Locations

Arms

Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebral Ischemia Brain Infarction	Drug: Ancrod (Viprinex) Drug: Placebo	Phase 3

Detailed Description

With prior approval by the FDA, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. This was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis.

Study Design

Study Type:

Interventional

Actual Enrollment :

277 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

ASP I (Ancrod Stroke Program) Study of Acute Viprinex™ for Emergency Stroke: A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex™) in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute, Ischemic Stroke

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous ancrod Intravenous ancrod infused at a rate of 0.167 IU/kg/hr (0.6 mL/kg/hr) for 2 or 3 hours depending on the pretreatment fibrinogen level.	Drug: Ancrod (Viprinex) 0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
Placebo Comparator: Intravenous Placebo Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.	Drug: Placebo 0.6 mL/kg/hr

Arm

Intervention/Treatment

Experimental: Intravenous ancrod

Intravenous ancrod infused at a rate of 0.167 IU/kg/hr (0.6 mL/kg/hr) for 2 or 3 hours depending on the pretreatment fibrinogen level.

Drug: Ancrod (Viprinex)

0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours

Placebo Comparator: Intravenous Placebo

Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.

Drug: Placebo

0.6 mL/kg/hr

Outcome Measures

Primary Outcome Measures

Responder analysis based on Modified Rankin Scale (mRS) [90 days]

Secondary Outcome Measures

National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
Baseline NIHSS > 5

Exclusion Criteria:

No intracranial, extravascular blood on CT
Hypertension (systolic > 185; diastolic > 105)
Baseline fibrinogen level < 100 mg/dL
Thrombocytopenia (< 100,000 / mm3)
Recent (< 3 days) or anticipated (< 5 days) use of a thrombolytic agent
Recent (< 14 days) or anticipated surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Hospital / Arizona	Phoenix	Arizona	United States	85054
2	Sparks Regional Medical Center	Fort Smith	Arkansas	United States	72901
3	Loma Linda University School of Medicine	Loma Linda	California	United States	92354
4	Santa Monica - UCLA Medical Center	Los Angeles	California	United States	90024
5	UCLA Medical Center	Los Angeles	California	United States	90024
6	Hoag Memorial Hospital	Newport Beach	California	United States	92658
7	The Neurology Center: Tri-City Medical Center	Oceanside	California	United States	92056
8	Shasta Regional Medical	Redding	California	United States	96001
9	Bridgeport Hospital	Bridgeport	Connecticut	United States	06610
10	Neurologic Consultants, P.A.	Fort Lauderdale	Florida	United States	33308
11	Shands Jacksonville / University of Florida	Jacksonville	Florida	United States	32209
12	Ocala Neurodiagnostic Center	Ocala	Florida	United States	34471
13	Florida Hospital Neuroloscience Institute	Orlando	Florida	United States	32804
14	Fawcett Memorial Hospital	Port Charlotte	Florida	United States	33952
15	Peace River Regional Medical Center	Port Charlotte	Florida	United States	33952
16	Tallahassee Memorial Healthcare, Inc.	Tallahassee	Florida	United States	32303
17	The Queens Medical Center, Neuroscience Institute	Honolulu	Hawaii	United States	96813
18	Mercy Hospital	Chicago	Illinois	United States	60616
19	Elkhart Clinic, LLC - Neurology	Elkhart	Indiana	United States	46514
20	Fort Wayne Neurological Center	Fort Wayne	Indiana	United States	46804
21	Parkview Research Center	Fort Wayne	Indiana	United States	46805
22	Sinai Hospital of Baltimore	Baltimore	Maryland	United States	21215
23	Baystate Medical Center	Springfield	Massachusetts	United States	01199
24	Wayne State University	Detroit	Michigan	United States	48201
25	St. Mary's Duluth Clinic	Duluth	Minnesota	United States	55805
26	Minneapolis Clinic of Neurology	Golden Valley	Minnesota	United States	55422
27	Deaconess Billings Clinical Research Center	Billings	Montana	United States	59101
28	NJ Neuroscience Institute	Edison	New Jersey	United States	08818
29	Neurology Consultants Of Burlington County	Lumberton	New Jersey	United States	08048
30	UMDNJ / Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
31	Neurology Group of Bergen County	Ridgewood	New Jersey	United States	07450
32	Shore Neurology	Toms River	New Jersey	United States	08755
33	Kaleida Stroke Center	Buffalo	New York	United States	14209
34	United Health Services Hospitals	Johnson City	New York	United States	13790
35	Winthrop University Hospital	Minneola	New York	United States	11501
36	Weill Medical College of Cornell University	New York	New York	United States	10021
37	Rochester General Hospital	Rochester	New York	United States	14621
38	Strong Memorial Hospital	Rochester	New York	United States	14642
39	Presbyterian Hospital	Charlotte	North Carolina	United States	28204
40	Lebauer Cardiovascular Research Foundation at Moses Cone Hospital	Greensboro	North Carolina	United States	27401
41	Clinical Research of Winston-Salem	Winston-Salem	North Carolina	United States	27103
42	The Toledo Hospital	Toledo	Ohio	United States	43606
43	Medical University of Ohio	Toledo	Ohio	United States	43614
44	Northshore Clinical Associates	Erie	Pennsylvania	United States	16507
45	Westmoreland Neurology Associates, Inc.	Greensburg	Pennsylvania	United States	15601
46	Miriam Hospital	Providence	Rhode Island	United States	02906
47	Beaufort Memorial Hospital	Beaufort	South Carolina	United States	34205
48	Methodist University Hospital	Memphis	Tennessee	United States	38104
49	Brackenridge Hospital	Austin	Texas	United States	78701
50	Seton Medical Center	Austin	Texas	United States	78705
51	Methodist Hospital / Neurological Institute	Houston	Texas	United States	77030
52	University of Texas Health Sciences Center	San Antonio	Texas	United States	78229
53	Virginia Commonwealth University	Richmond	Virginia	United States	23219
54	Neurological Consultants of Virginia Beach	Virginia Beach	Virginia	United States	23454
55	Harborview Medical Center	Seattle	Washington	United States	98104
56	Madigan Army Medical Center	Tacoma	Washington	United States	98431
57	St. Lukes Medical Center	Milwaukee	Wisconsin	United States	53215
58	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226
59	Gosford Hospital Department of Neurology	Gosford	New South Wales	Australia	2250
60	Flinders Medical Centre	Bedford Park	South Australia	Australia	5042
61	Box Hill Hospital	Box Hill	Victoria	Australia
62	National Stroke Research Institute	Heidelberg Heights	Victoria	Australia	3081
63	Grey Nuns Community Hospital	Edmonton	Alberta	Canada	1100
64	Western Memorial Health Clinic	Corner Brook	Newfoundland and Labrador	Canada	A2H 4B8
65	London Health Sciences Centre - University Hospital	London	Ontario	Canada
66	Trillum Health Centre	Mississauga	Ontario	Canada	L5B1B8
67	Hospital Charles-Leymoyne	Greenfield Park	Quebec	Canada	J4V2h1
68	University of Alberta Hospital	Edmonton		Canada	T6G2B7
69	Thunder Bay Regional Health Sciences Centre	Thunder Bay		Canada	P7B7C7
70	St. Anne's Faculty Hospital	Brno		Czech Republic	65691
71	Faculty Hospital 1, The Clinic of Neurology	Pilsen		Czech Republic	30460
72	St. Anna Hospital	Geldrop		Netherlands	5660 AB
73	University Clinical Hospital	Warsaw		Poland	02-097
74	City Hospital #31	Moscow		Russian Federation	119415
75	Research Institute of Neurology RAMS	Moscow		Russian Federation	125367
76	Military Medical Akademy Dept of Neurology	St. Petersburg		Russian Federation	194044
77	St. Augustine's Hospital	Berea, Durban	Kwazulu Natal	South Africa	4001
78	Tiervlei Trial Centre	Cape Town		South Africa	7536
79	Vergelegen Medi-Clinic	Somerset West		South Africa	7130
80	Sunninghill Hospital	Sunninghill		South Africa	2157
81	Changhua Christian Hospital, Chief Department of Neurology	Changhua		Taiwan	50022
82	Lo-Tung Pohai Hospital, Department of Neurology	IIan		Taiwan	265
83	Chung-Ho Memorial Hospital Kaohsiung Medical University	Kaohsiung		Taiwan	807
84	Kaohsiung Chang-Gung, Memorial Hospital	Kaohsiung		Taiwan	83305
85	Chung Shan Medical Hospital	Taichung		Taiwan	402
86	China Medical University Hospital	Taichung		Taiwan	404
87	Taichung Veterans General Hospital, Section of Neurology	Taichung		Taiwan	407
88	Kuang-Tien General Hospital	Taichung		Taiwan	433
89	Chi-Mei Medical Center	Tainan		Taiwan	710
90	National Taiwan University Hospital	Taipei City		Taiwan	100
91	Cathay General Hospital Department of Neurology	Taipei City		Taiwan	11073
92	Shin-Kong WHS Memorial Hospital	Taipei		Taiwan	111
93	Tri-Service General Hospital	Taipei		Taiwan	114
94	Far Eastern Memorial Hospital	Taipei		Taiwan	220
95	En Chu Kong Hospital	Taipei		Taiwan	23702
96	Chang-Gung Memorial Hospital Linko Medical Center	Taoyuang		Taiwan	333
97	Chang-Gung Memorial Hospital, Linko Medical Center	Taoyuang		Taiwan	333
98	University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics	Aberdeen		United Kingdom	AB252ZD
99	Institute of Neurological Sciences Southern General Hospital	Glasgow		United Kingdom	G514TF
100	Royal Victoria Infirmary - Clinical Research Center	New Castle		United Kingdom