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Sponsors and Collaborators: |
University of Virginia National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00252239 |
The purpose of this study is to determine which of 3 different doses of tenecteplase (TNK) is better for treating stroke patients and if TNK offers an advantage over currently available treatment with tissue plasminogen activator (tPA).
Condition | Intervention | Phase |
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Stroke |
Drug: tenecteplase Drug: tissue plasminogen activator, tPA |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment |
Official Title: | Phase 2B Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B) |
Estimated Enrollment: | 600 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
tenecteplase
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Drug: tenecteplase
This study will compare 3 different doses of tenecteplase to tPA.
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2: Active Comparator
tissue plasminogen activator, tPA
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Drug: tissue plasminogen activator, tPA
To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.
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Stroke is the third leading cause of death and a leading cause of adult disability in the United States and worldwide. To date, the only scientifically-proven and FDA-approved treatment for acute stroke is the clot-busting drug, tissue plasminogen activator (tPA). A newer clot-busting drug, tenecteplase (TNK), has chemical properties that make it a potentially safer and more effective drug for treating stroke. Preliminary testing of TNK in patients with acute stroke has been encouraging enough to warrant further testing.
This study, TNK-S2B, will compare three different doses of TNK with standard tPA treatment in patients with acute stroke. Patients will be chosen randomly to receive either TNK or tPA. Neither the patient nor his/her doctor will know which medication the patient received until the study is completely finished.
The first part of the study will look at results of treatment in the first 24 hours to select the best dose of TNK to carry forward into a more detailed comparison with standard tPA treatment. After at least 100-150 pairs of the best dose of TNK and tPA patients have been enrolled, entry into the study will pause, and the outcomes at 3 months after stroke will be compared to see if the results of TNK treatment are sufficiently promising as an improvement over standard treatment to justify expanding the study to find a definitive answer.
The study, which will be conducted in at least 8 large medical centers, is expected to last about 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cynthia Beebe, R.N. | 434 243 6327 | cab7u@virginia.edu |
Contact: Mirna Aponte-Quintero | 212 342 1250 |
United States, California | |
University of California at San Diego | Recruiting |
San Diego, California, United States, 92103-8466 | |
Contact: Allysa Chardi 619-543-7760 | |
United States, Colorado | |
Colorado Neurological Institutes | Recruiting |
Englewood, Colorado, United States, 80113-2771 | |
Contact: Carol Greenwald, M.D. 303-806-7418 | |
United States, Maryland | |
Johns Hopkins-Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Janice Alt, RN 410-550-2987 | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0316 | |
Contact: Kate Maddox, RN 734-936-9075 | |
United States, New York | |
Long Island Jewish Hospital | Recruiting |
New Hyde Park, New York, United States, 11040 | |
Contact: Marietta Manlulu 718-470-7706 | |
Columbia University, Statistical Analysis Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Mirna Aponte-Quintero 212-342-1250 | |
Mount Sinai Medical Center | Recruiting |
New York, New York, United States, 10029 | |
Contact: Sandra Augustine, RN 212-241-5320 | |
United States, Texas | |
University of Texas at Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Loralee Nguyen 713-500-7183 | |
United States, Virginia | |
University of Virginia Health System | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Cynthia Beebe, RN 434-243-6327 cab7u@virginia.edu |
Principal Investigator: | E. Clarke Haley, Jr., M.D. | Clinical Coordinating Center, Department of Neurology, University of Virginia Health System |
Principal Investigator: | John L. P. Thompson, Ph.D. | Statistical Analysis Center, Department of Biostatistics, Mailman School of Public Health |
Responsible Party: | University of Virginia Health System ( E. Clarke Haley, Jr., M.D., Director of The Stroke Center, Alumni Professor of Neurology and Neurosurgery ) |
Study ID Numbers: | R01NS37666, R01NS45170 |
Study First Received: | November 10, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00252239 |
Health Authority: | United States: Food and Drug Administration |
stroke tenecteplase TNK |
ischemic tissue plasminogen activator tPA |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Tenecteplase Tissue Plasminogen Activator Ischemia |
Brain Diseases Cerebrovascular Disorders Brain Ischemia Brain Infarction Infarction Plasminogen |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents Nervous System Diseases |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |