NCT07111806

Intravenous Tirofiban After Delayed Thrombolysis in Stroke

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 852 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Tirofiban	Tirofiban is administered as a loading dose and continuous intravenous infusion as soon as possible after the randomization.
DRUG	Placebo	Matched placebo will be infused in a similar fashion.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-12-01
• Completion: 2029-03-01
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: China