TIMELESS Study

Condition: Stroke

Eligibility

Key Inclusion Criteria

  • Stroke symptom onset within 4.5 to 24 hours
  • At least 18 years old
  • Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke

Key Exclusion Criteria

  • Participation in another investigational drug or device study
  • Known hypersensitivity or allergy to any ingredients of tenecteplase
  • Active internal bleeding

Full Study Name

A Phase III, Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Thrombolysis in Imaging-Eligible, Late-Window Patients to Assess the Efficacy and Safety of Tenecteplase (TIMELESS) (IRB no. 55773)

Summary

The purpose of this study is to compare the effects of a drug called tenecteplase to placebo (inactive substance) in patients with acute ischemic stroke. Participants will receive either tenecteplase or placebo (inactive substance), in addition to the current standard of care for stroke. Tenecteplase is approved by the U.S. Food and Drug Administration (FDA) for the treatment of myocardial infarction (heart attack), but it is not approved for the treatment of stroke.

Phase

Phase III

Site Principal Investigator

Shlee Song, MD

Contact

Vicki Manoukian
Phone: 310-423-5067
Email: vicki.manoukian@cshs.org