StrokePhase 3NCT00141011
Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
A Phase 3 study testing Ancrod (Viprinex) in people with Stroke and Cerebral Ischemia, run by Neurobiological Technologies at 100 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Ischemia, Brain Infarction
- What is being tested?
- Ancrod (Viprinex)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- 100 sitesin 10 countries
- Study dates
- Sep 2005to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS > 5
Who cannot join
- 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
Trial locations and contacts
100 sites in 10 countries.
100 sites in 10 countries
United States58 sites
Brackenridge Hospital
Austin, Texas, 78701
Seton Medical Center
Austin, Texas, 78705
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Beaufort Memorial Hospital
Beaufort, South Carolina, 34205
Deaconess Billings Clinical Research Center
Billings, Montana, 59101
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Kaleida Stroke Center
Buffalo, New York, 14209
Presbyterian Hospital
Charlotte, North Carolina, 28204
Mercy Hospital
Chicago, Illinois, 60616
Wayne State University
Detroit, Michigan, 48201
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805
NJ Neuroscience Institute
Edison, New Jersey, 08818
Elkhart Clinic, LLC - Neurology
Elkhart, Indiana, 46514
Northshore Clinical Associates
Erie, Pennsylvania, 16507
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, 33308
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
Parkview Research Center
Fort Wayne, Indiana, 46805
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, 55422
Lebauer Cardiovascular Research Foundation at Moses Cone Hospital
Greensboro, North Carolina, 27401
Westmoreland Neurology Associates, Inc.
Greensburg, Pennsylvania, 15601
The Queens Medical Center, Neuroscience Institute
Honolulu, Hawaii, 96813
Methodist Hospital / Neurological Institute
Houston, Texas, 77030
Shands Jacksonville / University of Florida
Jacksonville, Florida, 32209
United Health Services Hospitals
Johnson City, New York, 13790
Loma Linda University School of Medicine
Loma Linda, California, 92354
Santa Monica - UCLA Medical Center
Los Angeles, California, 90024
UCLA Medical Center
Los Angeles, California, 90024
Neurology Consultants Of Burlington County
Lumberton, New Jersey, 08048
Methodist University Hospital
Memphis, Tennessee, 38104
St. Lukes Medical Center
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Winthrop University Hospital
Minneola, New York, 11501
UMDNJ / Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Weill Medical College of Cornell University
New York, New York, 10021
Hoag Memorial Hospital
Newport Beach, California, 92658
Ocala Neurodiagnostic Center
Ocala, Florida, 34471
The Neurology Center: Tri-City Medical Center
Oceanside, California, 92056
Florida Hospital Neuroloscience Institute
Orlando, Florida, 32804
Mayo Clinic Hospital / Arizona
Phoenix, Arizona, 85054
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
Peace River Regional Medical Center
Port Charlotte, Florida, 33952
Miriam Hospital
Providence, Rhode Island, 02906
Shasta Regional Medical
Redding, California, 96001
Virginia Commonwealth University
Richmond, Virginia, 23219
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450
Rochester General Hospital
Rochester, New York, 14621
Strong Memorial Hospital
Rochester, New York, 14642
University of Texas Health Sciences Center
San Antonio, Texas, 78229
Harborview Medical Center
Seattle, Washington, 98104
Baystate Medical Center
Springfield, Massachusetts, 01199
Madigan Army Medical Center
Tacoma, Washington, 98431
Tallahassee Memorial Healthcare, Inc.
Tallahassee, Florida, 32303
The Toledo Hospital
Toledo, Ohio, 43606
Medical University of Ohio
Toledo, Ohio, 43614
Shore Neurology
Toms River, New Jersey, 08755
Neurological Consultants of Virginia Beach
Virginia Beach, Virginia, 23454
Clinical Research of Winston-Salem
Winston-Salem, North Carolina, 27103
Taiwan17 sites
Changhua Christian Hospital, Chief Department of Neurology
Changhua, 50022
Lo-Tung Pohai Hospital, Department of Neurology
IIan, 265
Chung-Ho Memorial Hospital Kaohsiung Medical University
Kaohsiung City, 807
Kaohsiung Chang-Gung, Memorial Hospital
Kaohsiung City, 83305
Chung Shan Medical Hospital
Taichung, 402
China Medical University Hospital
Taichung, 404
Taichung Veterans General Hospital, Section of Neurology
Taichung, 407
Kuang-Tien General Hospital
Taichung, 433
Chi-Mei Medical Center
Tainan, 710
National Taiwan University Hospital
Taipei, 100
Cathay General Hospital Department of Neurology
Taipei, 11073
Shin-Kong WHS Memorial Hospital
Taipei, 111
Tri-Service General Hospital
Taipei, 114
Far Eastern Memorial Hospital
Taipei, 220
En Chu Kong Hospital
Taipei, 23702
Chang-Gung Memorial Hospital Linko Medical Center
Taoyuang, 333
Chang-Gung Memorial Hospital, Linko Medical Center
Taoyuang, 333
Canada7 sites
Western Memorial Health Clinic
Corner Brook, Newfoundland and Labrador, A2H 4B8
Grey Nuns Community Hospital
Edmonton, Alberta, 1100
University of Alberta Hospital
Edmonton, T6G2B7
Hospital Charles-Leymoyne
Greenfield Park, Quebec, J4V2h1
London Health Sciences Centre - University Hospital
London, Ontario
Trillum Health Centre
Mississauga, Ontario, L5B1B8
Thunder Bay Regional Health Sciences Centre
Thunder Bay, P7B7C7
Australia4 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria
Gosford Hospital Department of Neurology
Gosford, New South Wales, 2250
National Stroke Research Institute
Heidelberg Heights, Victoria, 3081
South Africa4 sites
St. Augustine's Hospital
Berea, Durban, KwaZulu-Natal, 4001
Tiervlei Trial Centre
Cape Town, 7536
Vergelegen Medi-Clinic
Somerset West, 7130
Sunninghill Hospital
Sunninghill, 2157
Russia3 sites
City Hospital #31
Moscow, 119415
Research Institute of Neurology RAMS
Moscow, 125367
Military Medical Akademy Dept of Neurology
Saint Petersburg, 194044
United Kingdom3 sites
University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics
Aberdeen, AB252ZD
Institute of Neurological Sciences Southern General Hospital
Glasgow, G514TF
Royal Victoria Infirmary - Clinical Research Center
Newcastle
Czechia2 sites
St. Anne's Faculty Hospital
Brno, 65691
Faculty Hospital 1, The Clinic of Neurology
Pilsen, 30460
About this study
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
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.
Read the 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.
- Conditions
- Stroke, Cerebral Ischemia, Brain Infarction
- Being tested
- Ancrod (Viprinex), Placebo
- Keywords
- Stroke, Fibrinogen, Reperfusion, Thrombolysis
- Medical subject headings
- Stroke, Brain Ischemia, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ancrod (Viprinex)Drug
0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
PlaceboDrug
0.6 mL/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Intravenous ancrod | Experimental | 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. Receives: Drug: Ancrod (Viprinex) |
| Intravenous Placebo | Placebo comparator | Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder analysis based on Modified Rankin Scale (mRS)
Measured: 90 days
Secondary outcomes (1)
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurobiological Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Warren Wasiewski, M.D., Study director, Neurobiological Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141011
- Sponsor's protocol ID
- NTI-ASP-0502
- Status last verified
- Dec 2009
- First submitted
- 30 Aug 2005
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00141011
- Acronym / sponsor ID
- NTI-ASP-0502
- Conditions
- Stroke, Cerebral Ischemia, Brain Infarction
- Keywords
- Stroke, Fibrinogen, Reperfusion, Thrombolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Neurobiological TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous ancrod | Experimental | Drug: Ancrod (Viprinex)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. |
| Intravenous Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
- Baseline NIHSS > 5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ancrod (Viprinex)0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours | Drug | Intravenous ancrod |
| Placebo0.6 mL/kg/hr | Drug | Intravenous Placebo |
Primary outcome
Responder analysis based on Modified Rankin Scale (mRS)
Time frame: 90 days
1 secondary outcome
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Related InfoLink provided by the sponsor.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Wasiewski, M.D. study director
Neurobiological Technologies
100 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ancrod (Viprinex) in people with Stroke and Cerebral Ischemia, run by Neurobiological Technologies at 100 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 sites in United States, Taiwan, Canada, Australia, South Africa and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder analysis based on Modified Rankin Scale (mRS) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2009.