Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-01 @ 1:58 AM
Study NCT ID:
NCT07111806
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Tirofiban After Delayed Thrombolysis in Stroke
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Study Overview
Official Title:
Intravenous Tirofiban Versus Placebo After Delayed Thrombolysis (4.5-24h) in Acute Ischemic Stroke (PEARL-TIRO): A Multicenter, Double-Blind, Double-Dummy, Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
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:
PEARL-TIRO
Brief Summary:
A multicenter, double-blind, double-dummy, randomized trial evaluating the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT).
Detailed Description:
This study is a multicenter, double-blind, double-dummy, randomized clinical trial designed to evaluate the efficacy and safety of intravenous tirofiban in acute ischemic stroke (AIS) patients without large/medium vessel occlusion, who presented 4.5-24 hours after onset and received intravenous thrombolysis (IVT). The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-1.
Study intervention: (1) Participants in the intervention group will receive intravenous tirofiban as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach.
All participants will receive standard medical treatment.
A total of 852 participants are anticipated to be recruited for this study, with 426 participants in each group (1:1 ratio).
Study intervention: (1) Participants in the intervention group will receive intravenous tirofiban as soon as possible after the randomization. (2) Participants in the control group will receive matched intravenous placebo in the same approach.
All participants will receive standard medical treatment.
A total of 852 participants are anticipated to be recruited for this study, with 426 participants in each group (1:1 ratio).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: