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