ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
This study has been terminated.
(Futility)
Sponsor:
Neurobiological Technologies
Information provided by:
Neurobiological Technologies
ClinicalTrials.gov Identifier:
NCT00300196
First received: March 6, 2006
Last updated: January 11, 2010
Last verified: January 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stroke Cerebral Ischemia Brain Infarction |
Biological: Ancrod (Viprinex) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Neurobiological Technologies:
Primary Outcome Measures:
- Modified Rankin Score - responder analysis [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Barthel Index, NIHSS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
| Enrollment: | 311 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Biological: Ancrod (Viprinex)
0.167 IU/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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300196
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Hide Study LocationsLocations
| United States, California | |
| Enloe Medical Center | |
| Chico, California, United States, 95973 | |
| UCSF-Fresno | |
| Fresno, California, United States, 93701 | |
| Sherry Braheny MD - A Prof. Corporation | |
| La Mesa, California, United States, 91942 | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95825 | |
| Los Robles Hospital and Medical Center | |
| Thousand Oaks, California, United States, 91360 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Manatee Memorial Hospital | |
| Bradenton, Florida, United States, 34208 | |
| Bradenton Research Center | |
| Bradenton, Florida, United States, 34250 | |
| Melbourne Internal Medicine Associates | |
| Melbourne, Florida, United States, 32901 | |
| Collier Neurologic Specialists | |
| Naples, Florida, United States, 34102 | |
| Naples Community Hospital | |
| Naples, Florida, United States, 34102 | |
| Suncoast Neuroscience Associates | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Georgia | |
| Joan Glancy Memorial Hospital | |
| Decatur, Georgia, United States, 30033 | |
| Joan Glancy Memorial Hospital | |
| Duluth, Georgia, United States, 30096 | |
| Gwinnett Medical Center | |
| Lawrenceville, Georgia, United States, 30045 | |
| Dekalb Medical Center-Hillandale | |
| Lithonia, Georgia, United States, 30058 | |
| Candler Hospital | |
| Savannah, Georgia, United States, 31405 | |
| St. Joseph's Hospital | |
| Savannah, Georgia, United States, 31419 | |
| United States, Illinois | |
| OSF Saint Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Bromenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| United States, Michigan | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Missouri | |
| Research Medical Center | |
| Kansas City, Missouri, United States, 64132 | |
| Saint Luke's Hospital Mid America Brain and Stroke Institute | |
| Kansas City, Missouri, United States, 64111 | |
| St. Louis University Hospital - Dept of Neurology | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Nevada Neuroscience Institute at Sunrise | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Jersey Shore University Medical Center | |
| Neptune, New Jersey, United States, 07753 | |
| Neuroscience Institute St Francis Medical Center | |
| Trenton, New Jersey, United States, 08629 | |
| United States, New York | |
| Lutheran Medical Center | |
| Brooklyn, New York, United States, 11220 | |
| Five Towns Neuroscience Research | |
| Lawrence, New York, United States, 11559 | |
| United States, Ohio | |
| Aultman Hospital | |
| Canton, Ohio, United States, 44710 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| United States, Pennsylvania | |
| Doylestown Hospital | |
| Doylestown, Pennsylvania, United States, 18901 | |
| Lancaster General Hospital | |
| Lancaster, Pennsylvania, United States, 17603 | |
| Hahenmann University Hospital | |
| Philadelphia, Pennsylvania, United States, 19102-1101 | |
| United States, South Carolina | |
| AnMed Health | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Tennessee | |
| Chattanooga Center for Neurologic Research | |
| Chattanooga, Tennessee, United States, 97401 | |
| United States, Washington | |
| Overlake Hospital Medical Center | |
| Bellevue, Washington, United States, 98004 | |
| Providence St. Peter Hospital | |
| Olympia, Washington, United States, 98506 | |
| United States, West Virginia | |
| CAMC Memorial Hospital | |
| Charleston, West Virginia, United States, 25304 | |
| Australia, New South Wales | |
| St Vincent's Hospital | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Australia, Queensland | |
| Gold Coast Hospital | |
| Southport, Queensland, Australia | |
| Australia, Victoria | |
| Moash Medical Center Dept of Neurology | |
| Clayton, Victoria, Australia, 3168 | |
| Royal Melbourne Hospital | |
| Parkville, Victoria, Australia, 3050 | |
| Alfred Hospital Research - Melbourne | |
| Prahan, Melbourne, Victoria, Australia, 3184 | |
| Australia | |
| Concord Hospital Neuroscience Department | |
| New South Wales, Australia | |
| Austria | |
| Medical University of Affairs | |
| Graz, Austria, 8036 | |
| Neurologische Intensivstation | |
| Linz, Austria, A4020 | |
| Czech Republic | |
| University Hospital Hradec Kralove Neurological Department | |
| Hradec-Kralove, Czech Republic, 500 05 | |
| PalackyUniversity Faculty of Medicine and Dentistry and University Hospital | |
| Olomouc, Czech Republic, 77520 | |
| Vitkovice Hospital Department of Neurology | |
| Ostrava, Czech Republic, 703 84 | |
| Regional Hospital Pardubice | |
| Pardubice, Czech Republic, 53 203 | |
| Thomayer's Faculty Clinic of Neurology | |
| Prague, Czech Republic, 14059 | |
| General University Hospital Clinic of Neurology-Stroke Center | |
| Prague, Czech Republic, 12000 | |
| University Hospital Motol Department of Neurology | |
| Prague, Czech Republic, 15006 | |
| Israel | |
| Barzilai Medical Center | |
| Ashkelon, Israel, 78306 | |
| Soroka Medical Center Dept of Neurology Ben-Gurion Univ of the Negev | |
| Beer Sheva, Israel, 84105 | |
| Rambam Medical Center Dept. of Neurology | |
| Haifa, Israel, 31096 | |
| Bnei-Zion Medical Center | |
| Haifa, Israel, 31048 | |
| Wolfson Medical Center | |
| Holon, Israel, 58100 | |
| Hadassah Ein-Karem Medical Center | |
| Jerusalem, Israel, 91120 | |
| Western Galilee Hospital Neurology Dept | |
| Nahariya, Israel, 22100 | |
| Rabin Medical Center Golda Campus (Hasharon) | |
| Petach Tikva, Israel, 49372 | |
| Tel-Aviv Medical Center | |
| Tel Aviv, Israel, 64239 | |
| Chaim Sheba Medical Center Neurology Dept | |
| Tel Hashomer, Israel, 52621 | |
| New Zealand | |
| Auckland City Hospital | |
| Auckland, New Zealand, 1001 | |
| Cristchurch Hospitial | |
| Christchurch, New Zealand, 4710 | |
| Poland | |
| Samodzielny Publiczny Szpital Kliniczny nr1, Akademickie Centrum | |
| Gdansk, Poland, 80294 | |
| Katedra i Klinika Neurologii, Wieku Podesziego | |
| Katowice, Poland, 40752 | |
| Klinika Neurologii Akademii Medycznej w Lublinie | |
| Lublin, Poland, 20090 | |
| Centrum Medycne HCP sp.zo.o Dept. Neurlogy | |
| Poznan, Poland, 61-485 | |
| Institute for Psychiatry and Neurology 2nd Neurology Dept. | |
| Warsaw, Poland, 02-957 | |
| Russian Federation | |
| City Clinical Hospital MU KGB Nr. 40 | |
| Ekaterinburg, Russian Federation, 620102 | |
| Jaroslav Regional Clinical Hospital State Institution of Healthcare | |
| Jaroslavl, Russian Federation | |
| State Multiregional Clinical Diagnostical GU MKDZ | |
| Kazan, Russian Federation, 420101 | |
| Burdenko Central Military Clinical Hospital of Ministry of Defense of Russia | |
| Moscow, Russian Federation | |
| Central clinical Hospital of the President of the Russian Federation | |
| Moscow, Russian Federation, 121359 | |
| Municipal Institution of Health City Clinical Hospital No. 1 | |
| Novosibirsk, Russian Federation, 630047 | |
| Hospital Baranov | |
| Petrozawodsk, Russian Federation | |
| Railway Hospital at Rostov-Glavnity of OJSC "Russian Railways" | |
| Rostov-on Don, Russian Federation, 344011 | |
| City Hospital Nr. 1 of Pirogov | |
| Samara, Russian Federation, 443096 | |
| State Medical University named after IP Pavlov Leo Tolstoj | |
| St Petersburg, Russian Federation | |
| City Clinic Neurology N2 of Marinski Hospital | |
| St. Petersburg, Russian Federation | |
| Multiprofile City Clinic No. 2 | |
| St. Petersburg, Russian Federation, 194354 | |
| Slovakia | |
| Fakultna nemocnica s poliklinikou Bratislava | |
| Bratislava, Slovakia, 81369 | |
| Vseobecna nemocnica s polokliniknikou Levoca a.s. | |
| Levoca, Slovakia, 05401 | |
| Martinska fakultna nemocnica | |
| Martin, Slovakia, 03659 | |
| Fakultna nemocnica Nitra | |
| Nitra, Slovakia, 949 01 | |
| Fakultna nemocnica Nitra | |
| Nitra, Slovakia, 95001 | |
| Nemocnica s poliklinikou Spisska | |
| Nova Ves, Slovakia, 05201 | |
| Fakultna nemocnica s poliklinikou J.A. Reimana | |
| Prestov, Slovakia, 08181 | |
| Fakultna nemocnica Trnava | |
| Trnava, Slovakia, 91775 | |
| South Africa | |
| Clinical Projects Research | |
| Worcester, South Africa, 6850 | |
| Switzerland | |
| Centre Hospitalier universitaire Vaudois, Dept. of Neurology | |
| Lausanne, Switzerland, 1011 | |
| Universitatsspital Zurich | |
| Zurich, Switzerland, CH8091 | |
Sponsors and Collaborators
Neurobiological Technologies
Investigators
| Study Director: | Warren Wasiewski, M.D. | Neurobiological Technologies |
More Information
Additional Information:
No publications provided
| Responsible Party: | Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc. (no longer active) |
| ClinicalTrials.gov Identifier: | NCT00300196 History of Changes |
| Other Study ID Numbers: | NTI-ASP-0503 |
| Study First Received: | March 6, 2006 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Neurobiological Technologies:
|
Stroke Fibrinogen Reperfusion Thrombolysis |
Additional relevant MeSH terms:
|
Cerebral Infarction Brain Ischemia Infarction Ischemia Stroke Brain Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Necrosis Ancrod Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013