Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252239
Status:
TERMINATED
Last Update Posted:
2015-03-17
First Post:
2005-11-10
Brief Title:
Study of Tenecteplase TNK in Acute Ischemic Stroke TNK-S2B
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Phase 2B Study of Tenecteplase TNK in Acute Ischemic Stroke TNK-S2B
Status:
TERMINATED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 hisher 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
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 hisher 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS037666 | NIH | None | httpsreporternihgovquickSearchR01NS037666 |
| R01NS045170 | NIH | None | None |