StrokePhase 3NCT00300196
ASP-II: Ancrod Stroke Program: 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 94 sites in 11 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
- 311 participants
- Where
- 94 sitesin 11 countries
- Study dates
- Mar 2006to 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
94 sites in 11 countries.
94 sites in 11 countries
United States39 sites
AnMed Health
Anderson, South Carolina, 29621
Overlake Hospital Medical Center
Bellevue, Washington, 98004
OSF Saint Joseph Medical Center
Bloomington, Illinois, 61701
Manatee Memorial Hospital
Bradenton, Florida, 34208
Bradenton Research Center
Bradenton, Florida, 34250
Lutheran Medical Center
Brooklyn, New York, 11220
Aultman Hospital
Canton, Ohio, 44710
CAMC Memorial Hospital
Charleston, West Virginia, 25304
Chattanooga Center for Neurologic Research
Chattanooga, Tennessee, 97401
Enloe Medical Center
Chico, California, 95973
Joan Glancy Memorial Hospital
Decatur, Georgia, 30033
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Joan Glancy Memorial Hospital
Duluth, Georgia, 30096
UCSF-Fresno
Fresno, California, 93701
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Saint Luke's Hospital Mid America Brain and Stroke Institute
Kansas City, Missouri, 64111
Research Medical Center
Kansas City, Missouri, 64132
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429
Sherry Braheny MD - A Prof. Corporation
La Mesa, California, 91942
Lancaster General Hospital
Lancaster, Pennsylvania, 17603
Nevada Neuroscience Institute at Sunrise
Las Vegas, Nevada, 89109
Five Towns Neuroscience Research
Lawrence, New York, 11559
Gwinnett Medical Center
Lawrenceville, Georgia, 30045
Dekalb Medical Center-Hillandale
Lithonia, Georgia, 30058
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901
Collier Neurologic Specialists
Naples, Florida, 34102
Naples Community Hospital
Naples, Florida, 34102
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Yale University School of Medicine
New Haven, Connecticut, 06510
Bromenn Regional Medical Center
Normal, Illinois, 61761
Providence St. Peter Hospital
Olympia, Washington, 98506
Hahenmann University Hospital
Philadelphia, Pennsylvania, 19102-1101
Mercy General Hospital
Sacramento, California, 95825
Candler Hospital
Savannah, Georgia, 31405
St. Joseph's Hospital
Savannah, Georgia, 31419
St. Louis University Hospital - Dept of Neurology
St Louis, Missouri, 63110
Suncoast Neuroscience Associates
St. Petersburg, Florida, 33701
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360
Neuroscience Institute St Francis Medical Center
Trenton, New Jersey, 08629
Russia12 sites
State Multiregional Clinical Diagnostical GU MKDZ
Kazan', 420101
Central clinical Hospital of the President of the Russian Federation
Moscow, 121359
Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia
Moscow
Municipal Institution of Health City Clinical Hospital No. 1
Novosibirsk, 630047
Hospital Baranov
Petrozavodsk
Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways"
Rostov-on-Don, 344011
Multiprofile City Clinic No. 2
Saint Petersburg, 194354
City Clinic Neurology N2 of Marinski Hospital
Saint Petersburg
State Medical University named after IP Pavlov Leo Tolstoj
Saint Petersburg
City Hospital Nr. 1 of Pirogov
Samara, 443096
Jaroslav Regional Clinical Hospital State Institution of Healthcare
Yaroslavl
City Clinical Hospital MU KGB Nr. 40
Yekaterinburg, 620102
Israel10 sites
Barzilai Medical Center
Ashkelon, 78306
Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev
Beersheba, 84105
Bnei-Zion Medical Center
Haifa, 31048
Rambam Medical Center Dept. of Neurology
Haifa, 31096
Wolfson Medical Center
Holon, 58100
Hadassah Ein-Karem Medical Center
Jerusalem, 91120
Western Galilee Hospital Neurology Dept
Nahariya, 22100
Rabin Medical Center Golda Campus (Hasharon)
Petah Tikva, 49372
Tel-Aviv Medical Center
Tel Aviv, 64239
Chaim Sheba Medical Center Neurology Dept
Tel HaShomer, 52621
Slovakia8 sites
Fakultna nemocnica s poliklinikou Bratislava
Bratislava, 81369
Vseobecna nemocnica s polokliniknikou Levoca a.s.
Levoča, 05401
Martinska fakultna nemocnica
Martin, 03659
Fakultna nemocnica Nitra
Nitra, 949 01
Fakultna nemocnica Nitra
Nitra, 95001
Nemocnica s poliklinikou Spisska
Nová Ves, 05201
Fakultna nemocnica s poliklinikou J.A. Reimana
Prestov, 08181
Fakultna nemocnica Trnava
Trnava, 91775
Czechia7 sites
University Hospital Hradec Kralove Neurological Department
Hradec Králové, 500 05
PalackyUniversity Faculty of Medicine and Dentistry and University Hospital
Olomouc, 77520
Vitkovice Hospital Department of Neurology
Ostrava, 703 84
Regional Hospital Pardubice
Pardubice, 53 203
General University Hospital Clinic of Neurology-Stroke Center
Prague, 12000
Thomayer's Faculty Clinic of Neurology
Prague, 14059
University Hospital Motol Department of Neurology
Prague, 15006
Australia6 sites
Moash Medical Center Dept of Neurology
Clayton, Victoria, 3168
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
Concord Hospital Neuroscience Department
New South Wales
Royal Melbourne Hospital
Parkville, Victoria, 3050
Alfred Hospital Research - Melbourne
Prahan, Melbourne, Victoria, 3184
Gold Coast Hospital
Southport, Queensland
Poland5 sites
Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum
Gdansk, 80294
Katedra i Klinika Neurologii, Wieku Podesziego
Katowice, 40752
Klinika Neurologii Akademii Medycznej w Lublinie
Lublin, 20090
Centrum Medycne HCP sp.zo.o Dept. Neurlogy
Poznan, 61-485
Institute for Psychiatry and Neurology 2nd Neurology Dept.
Warsaw, 02-957
Austria2 sites
Medical University of Affairs
Graz, 8036
Neurologische Intensivstation
Linz, A4020
New Zealand2 sites
Auckland City Hospital
Auckland, 1001
Cristchurch Hospitial
Christchurch, 4710
Switzerland2 sites
Centre Hospitalier universitaire Vaudois, Dept. of Neurology
Lausanne, 1011
Universitatsspital Zurich
Zurich, CH8091
About this study
Official title: ASP II (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)Biological
0.167 IU/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: Biological: 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.
Modified Rankin Score - responder analysis
Measured: 90 days
Secondary outcomes (1)
Barthel Index, NIHSS
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 posted8 Mar 2006 (estimated)
- Study startMar 2006
- 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
- 311 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
- NCT00300196
- Sponsor's protocol ID
- NTI-ASP-0503
- Status last verified
- Jan 2010
- First submitted
- 6 Mar 2006
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASP II (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
- NCT00300196
- Acronym / sponsor ID
- NTI-ASP-0503
- Conditions
- Stroke, Cerebral Ischemia, Brain Infarction
- Keywords
- Stroke, Fibrinogen, Reperfusion, Thrombolysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Neurobiological TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Mar 2006 (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 | Biological: 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 IV for 2-3 hours | Biological | Intravenous ancrod |
| Placebo0.6 mL/kg/hr | Drug | Intravenous Placebo |
Primary outcome
Modified Rankin Score - responder analysis
Time frame: 90 days
1 secondary outcome
Barthel Index, NIHSS
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 12 Jan 2010.
- Related InfoLink provided by the sponsor.
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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
94 sites in 11 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 94 sites in 11 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Russia, Israel, Slovakia, Czechia and 6 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?
Modified Rankin Score - responder analysis (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 12 Jan 2010.