Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

Terminated

Phase 2 Results

Trial Description

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 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.

Trial Stopped: Slow enrollment

Conditions

Interventions

  • Tissue plasminogen activator (Activase┬«)Drug
    Other Names: Alteplase; tPA
    Intervention Desc: Thrombolytic
  • Tenecteplase (TNKase)Drug
    Other Names: TNK
    Intervention Desc: This study will compare 3 different doses of tenecteplase to tPA.
    ARM 1: Kind: Experimental
    Label: 1
    Description: tenecteplase
  • Tissue plasminogen activator, tPA Drug
    Other Names: tPA
    Intervention Desc: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke.
    ARM 1: Kind: Experimental
    Label: 2
    Description: tissue plasminogen activator, tPA

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Handicap (Modified Rankin Score).
Secondary 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.
Primary Functional Handicap (Modified Rankin Score) 3 months No
Secondary 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 3 months No

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