Ignite Creation Date:
2024-05-06 @ 12:31 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03785678
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2018-12-19
Brief Title:
Tenecteplase in Stroke Patients Between 45 and 24 Hours
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMELESS
Brief Summary:
This study will evaluate the efficacy and safety of tenecteplase compared with placebo in participants with acute ischemic stroke AIS
All participants will receive standard-of-care therapy according to AmericanHeart AssociationAmerican Stroke Association clinical guidelines 2018 To determine eligibility for randomization all participants will undergo multimodal CT or MRI at baseline Only participants with a vessel occlusion ICA or MCA M1M2 and penumbral tissue will be randomized The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90
All participants will receive standard-of-care therapy according to AmericanHeart AssociationAmerican Stroke Association clinical guidelines 2018 To determine eligibility for randomization all participants will undergo multimodal CT or MRI at baseline Only participants with a vessel occlusion ICA or MCA M1M2 and penumbral tissue will be randomized The primary analysis is to compare the efficacy of tenecteplase versus placebo in all participants at Day 90
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None