NCT07095790

Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.

Detailed description

Although dual antiplatelet therapy (DAPT) reduces stroke recurrence and disability risks, its efficacy is limited in patients with mild ischemic stroke (NIHSS ≤5), among whom early neurological deterioration (END) and poor functional outcomes are frequently observed. Notably, intravenous thrombolysis is not more effective than DAPT for mild stroke management. Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has shown potential efficacy in mild-to-moderate ischemic stroke, but robust evidence specific to mild stroke remains lacking. This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.

Conditions

• Mild Stroke

Interventions

Type	Name	Description
DRUG	Tirofiban+Oral Dual Antiplatelet Therapy	Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 47.5 hours; sequential Oral Dual Antiplatelet Therapy (Aspirin 100mg qd; Clopidogrel 75mg qd)
DRUG	Oral Dual Antiplatelet Therapy	Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)

Timeline

• Start date: 2025-08-30
• Primary completion: 2027-02-28
• Completion: 2027-05-31
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

18 sites across 1 country: China