NCT05728333

Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

Detailed description

Intravenous alteplase bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous alteplase prior to EVT in LVO stroke, have suggested that intravenous alteplase should not be omitted. Although intravenous alteplase results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous alteplase is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, alteplase is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and alteplase in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus alteplase prior to EVT for acute ischemic stroke patients with LVO.

Conditions

• Stroke, Acute Ischemic

Interventions

Type	Name	Description
DRUG	Tirofiban	Intravenous tirofiban before endovascular thrombectomy.
DRUG	Alteplase	Intravenous alteplase before endovascular thrombectomy.

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-02-28
• Completion: 2026-07-31
• First posted: 2023-02-15
• Last updated: 2025-12-26

Locations

1 site across 1 country: China