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HOSPITAL REPORT

The premier resource for hospital professionals from Relias Media, the trusted source for healthcare information and continuing education.

IV Tenecteplase for Stroke Beyond 4.5 Hours: The Bullet Points

February 13th, 2025

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Background

Standard treatment for acute ischemic stroke involves intravenous thrombolysis within 4.5 hours of symptom onset, historically using alteplase. Recently, tenecteplase has been adopted as an alternative due to its single-bolus administration and lower cost, with studies confirming its noninferiority to alteplase.

Advanced imaging techniques, such as computed tomography (CT) perfusion or perfusion-diffusion magnetic resonance imaging (MRI), now allow identification of viable brain tissue in patients beyond the 4.5-hour window. The TIMELESS trial aimed to evaluate whether tenecteplase given between 4.5 and 24 hours post-stroke could improve outcomes in patients undergoing endovascular thrombectomy.

Study Design (TIMELESS Trial)

  • Multicenter, double-blind, randomized, placebo-controlled study.
  • Inclusion criteria:
    • Patients with large artery occlusion (internal carotid or middle cerebral artery).
    • Presence of salvageable brain tissue confirmed via CT or MRI perfusion imaging.
  • Treatment:
    • Tenecteplase (0.25 mg/kg) vs. placebo, administered 4.5 to 24 hours after symptom onset.
    • Majority (77.3%) of patients underwent subsequent endovascular thrombectomy.

Key Findings

  • Total patients enrolled: 458
    • Tenecteplase group: 228 patients
    • Placebo group: Remaining patients
  • Median time from last known well to randomization:
    • 12 hours (tenecteplase group)
    • 13 hours (placebo group)
  • Primary outcome (90-day modified Rankin Scale score):
    • No significant difference (median score = 3 in both groups).
  • Mortality rates:
    • 19.7% (tenecteplase) vs. 18.2% (placebo) → No significant difference.
  • Symptomatic intracranial hemorrhage (sICH) rates:
    • 3.2% (tenecteplase) vs. 2.3% (placebo) → Similar safety profile.

Conclusion

  • Tenecteplase administered beyond 4.5 hours (up to 24 hours) did not improve clinical outcomes compared to placebo in stroke patients undergoing endovascular thrombectomy.
  • No significant difference in mortality or adverse events between the groups.

For an expanded look at the TIMELESS trial and its results, click here.