Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)
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).
Drug: tissue plasminogen activator, tPA
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 2B Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)|
- Functional Handicap (Modified Rankin Score) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Major Neurological Improvement at 24 hours; Activities of Daily Living at 3 months; Neurological Deficits at 3 months; Functional/Cognitive Outcome at 3 months; Safety [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|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)|
Active Comparator: 1
This study will compare 3 different doses of tenecteplase to tPA.
Other Name: TNK
Active Comparator: 2
tissue plasminogen activator, tPA
Drug: tissue plasminogen activator, tPA
To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.
Other Name: tPA
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.
|United States, California|
|University of California at San Diego|
|San Diego, California, United States, 92103-8466|
|United States, Colorado|
|Colorado Neurological Institutes|
|Englewood, Colorado, United States, 80113-2771|
|United States, Maryland|
|Johns Hopkins-Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-0316|
|United States, New York|
|Long Island Jewish Hospital|
|New Hyde Park, New York, United States, 11040|
|Columbia University, Statistical Analysis Center|
|New York, New York, United States, 10032|
|Mount Sinai Medical Center|
|New York, New York, United States, 10029|
|United States, Texas|
|University of Texas at Houston|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|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|