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

NCT00141011 | Terminated Phase 3 DMC

• 1 other identifier: NTI-ASP-0502
• Study Type: interventional
• Target: 277
• Locations: 10 countries
• Sites: 100

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.

Conditions

Stroke; Cerebral Ischemia; Brain Infarction

Keywords

Stroke; Fibrinogen; Reperfusion; Thrombolysis

Outcome Measures

Primary Outcomes (1)

• Responder analysis based on Modified Rankin Scale (mRS)

  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

  90 days

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Ancrod (Viprinex) DRUG

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

Intravenous ancrod

Placebo DRUG

0.6 mL/kg/hr

Intravenous Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurobiological Technologies: lead

Study Sites (100)

Mayo Clinic Hospital / Arizona

Phoenix, Arizona, 85054, United States

Location

Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States

Location

Loma Linda University School of Medicine

Loma Linda, California, 92354, United States

Location

Santa Monica - UCLA Medical Center

Los Angeles, California, 90024, United States

Location

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

Hoag Memorial Hospital

Newport Beach, California, 92658, United States

Location

The Neurology Center: Tri-City Medical Center

Oceanside, California, 92056, United States

Location

Shasta Regional Medical

Redding, California, 96001, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Neurologic Consultants, P.A.

Fort Lauderdale, Florida, 33308, United States

Location

Shands Jacksonville / University of Florida

Jacksonville, Florida, 32209, United States

Location

Ocala Neurodiagnostic Center

Ocala, Florida, 34471, United States

Location

Florida Hospital Neuroloscience Institute

Orlando, Florida, 32804, United States

Location

Fawcett Memorial Hospital

Port Charlotte, Florida, 33952, United States

Location

Peace River Regional Medical Center

Port Charlotte, Florida, 33952, United States

Location

Tallahassee Memorial Healthcare, Inc.

Tallahassee, Florida, 32303, United States

Location

The Queens Medical Center, Neuroscience Institute

Honolulu, Hawaii, 96813, United States

Location

Mercy Hospital

Chicago, Illinois, 60616, United States

Location

Elkhart Clinic, LLC - Neurology

Elkhart, Indiana, 46514, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46804, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46805, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

St. Mary's Duluth Clinic

Duluth, Minnesota, 55805, United States

Location

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

Deaconess Billings Clinical Research Center

Billings, Montana, 59101, United States

Location

NJ Neuroscience Institute

Edison, New Jersey, 08818, United States

Location

Neurology Consultants Of Burlington County

Lumberton, New Jersey, 08048, United States

Location

UMDNJ / Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Neurology Group of Bergen County

Ridgewood, New Jersey, 07450, United States

Location

Shore Neurology

Toms River, New Jersey, 08755, United States

Location

Kaleida Stroke Center

Buffalo, New York, 14209, United States

Location

United Health Services Hospitals

Johnson City, New York, 13790, United States

Location

Winthrop University Hospital

Minneola, New York, 11501, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Lebauer Cardiovascular Research Foundation at Moses Cone Hospital

Greensboro, North Carolina, 27401, United States

Location

Clinical Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Medical University of Ohio

Toledo, Ohio, 43614, United States

Location

Northshore Clinical Associates

Erie, Pennsylvania, 16507, United States

Location

Westmoreland Neurology Associates, Inc.

Greensburg, Pennsylvania, 15601, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Beaufort Memorial Hospital

Beaufort, South Carolina, 34205, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Brackenridge Hospital

Austin, Texas, 78701, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

Methodist Hospital / Neurological Institute

Houston, Texas, 77030, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Neurological Consultants of Virginia Beach

Virginia Beach, Virginia, 23454, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

St. Lukes Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Gosford Hospital Department of Neurology

Gosford, New South Wales, 2250, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Box Hill Hospital

Box Hill, Victoria, Australia

Location

National Stroke Research Institute

Heidelberg Heights, Victoria, 3081, Australia

Location

Grey Nuns Community Hospital

Edmonton, Alberta, 1100, Canada

Location

Western Memorial Health Clinic

Corner Brook, Newfoundland and Labrador, A2H 4B8, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Location

Trillum Health Centre

Mississauga, Ontario, L5B1B8, Canada

Location

Hospital Charles-Leymoyne

Greenfield Park, Quebec, J4V2h1, Canada

Location

University of Alberta Hospital

Edmonton, T6G2B7, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, P7B7C7, Canada

Location

St. Anne's Faculty Hospital

Brno, 65691, Czechia

Location

Faculty Hospital 1, The Clinic of Neurology

Pilsen, 30460, Czechia

Location

St. Anna Hospital

Geldrop, 5660 AB, Netherlands

Location

University Clinical Hospital

Warsaw, 02-097, Poland

Location

City Hospital #31

Moscow, 119415, Russia

Location

Research Institute of Neurology RAMS

Moscow, 125367, Russia

Location

Military Medical Akademy Dept of Neurology

Saint Petersburg, 194044, Russia

Location

St. Augustine's Hospital

Berea, Durban, KwaZulu-Natal, 4001, South Africa

Location

Tiervlei Trial Centre

Cape Town, 7536, South Africa

Location

Vergelegen Medi-Clinic

Somerset West, 7130, South Africa

Location

Sunninghill Hospital

Sunninghill, 2157, South Africa

Location

Changhua Christian Hospital, Chief Department of Neurology

Changhua, 50022, Taiwan

Location

Lo-Tung Pohai Hospital, Department of Neurology

IIan, 265, Taiwan

Location

Chung-Ho Memorial Hospital Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Chang-Gung, Memorial Hospital

Kaohsiung City, 83305, Taiwan

Location

Chung Shan Medical Hospital

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital, Section of Neurology

Taichung, 407, Taiwan

Location

Kuang-Tien General Hospital

Taichung, 433, Taiwan

Location

Chi-Mei Medical Center

Tainan, 710, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Cathay General Hospital Department of Neurology

Taipei, 11073, Taiwan

Location

Shin-Kong WHS Memorial Hospital

Taipei, 111, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

En Chu Kong Hospital

Taipei, 23702, Taiwan

Location

Chang-Gung Memorial Hospital Linko Medical Center

Taoyuang, 333, Taiwan

Location

Chang-Gung Memorial Hospital, Linko Medical Center

Taoyuang, 333, Taiwan

Location

University of Aberdeen, Polwarth Building, Institute of Medical Sciences, Dept. of Medicine & Theropeutics

Aberdeen, AB252ZD, United Kingdom

Location

Institute of Neurological Sciences Southern General Hospital

Glasgow, G514TF, United Kingdom

Location

Royal Victoria Infirmary - Clinical Research Center

Newcastle, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Stroke; Brain Ischemia; Brain Infarction

Interventions

Ancrod

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Venombin A; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Crotalid Venoms; Viper Venoms; Snake Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Warren Wasiewski, M.D.

  Neurobiological Technologies

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

US (58); GB (3); CA (7); ZA (4); NL (1); PL (1); AU (4); RU (3); TW (17); CZ (2)