ASSENT-2 Study Design and Methodology

Assessment of the Safety and Efficacy

  • International, randomized, double-blind trial 1

Study Design 1

Double-blind, randomized, controlled trial to compare the efficacy and safety of accelerated infusion of Activase® (alteplase) vs single-bolus TNKase dosed according to estimated or actual weight, if available.

Primary Endpoint and Results 1

  • All-cause mortality at 30 days
    • 6.2% for TNKase (n=8461), 6.2% for Activase (n=8488) (relative risk 1.00; 95% CI=0.89-1.12; absolute difference=0.0%)

Secondary Endpoints and Results 1

  • Intracranial hemorrhage (ICH) at 30 days
    • 0.9% for TNKase (n=8461), 0.9% for Activase (n=8488) (relative risk 0.99; 95% CI=0.73-1.35; absolute difference 0.0%)
  • Any stroke at 30 days
    • 1.8% for TNKase, 1.7% for Activase (relative risk 1.07; 95% CI=0.86-1.35; absolute difference 0.1%)
  • Death or nonfatal stroke at 30 days
    • 7.1% for TNKase, 7.0% for Activase (relative risk 1.01; 95% CI=0.91-1.13; absolute difference 0.1%)
  • Major noncerebral bleeding events
    • Reduced rate of major noncerebral bleeding*—4.7% for TNKase, 5.9% for Activase (relative risk 0.78; 95% CI=0.69-0.89; absolute difference 1.2%)
    • Reduced need for blood transfusions—4.3% for TNKase, 5.5% for Activase (relative risk 0.77; 95% CI=0.67-0.89; absolute difference 1.2%)

*Major bleeding is defined as bleeding requiring blood transfusion or leading to hemodynamic compromise.

Primary Endpoint Results: 30-Day Mortality

Intracranial Hemorrhage (ICH) and Stroke

Major Noncerebral Bleeds

Transfusions

TNKase Survival Probability Curves

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