Tirofiban with sequential dual antiplatelet therapy in mild acute ischemic stroke (TiMIS): protocol for a...

Patients with mild acute ischemic stroke (AIS) (NIHSS score ≤5) remain at substantial risk for early neurological deterioration (END) and poor functional outcomes despite receiving standard dual antiplatelet therapy (DAPT). Tirofiban, a rapid-onset glycoprotein IIb/IIIa receptor inhibitor, may reduce this risk; however, evidence in patients with mild AIS is limited.

To determine whether administration of intravenous tirofiban for 48 h followed by DAPT improves the proportion of patients with excellent functional outcomes (modified Rankin Scale [mRS] score 0-1) at 90 days compared with administration of DAPT alone in patients with mild noncardioembolic AIS within 48 h of onset.

The TiMIS trial is a prospective, multicenter, open-label, blinded-endpoint (PROBE), randomized controlled study. A total of 688 patients aged 18-80 years with noncardioembolic acute mild ischemic stroke within 48 h of symptom onset will be enrolled across 20 centers in China. Participants are randomized 1:1 to intravenous tirofiban for 48 h sequentially followed by DAPT or DAPT alone. The primary outcome is the proportion of patients with excellent functional outcomes at 90 days. Secondary outcomes include END, changes in the NIHSS score, good functional outcome, mRS score shift, incidence of new ischemic stroke and composite cardiovascular events, and safety endpoints (symptomatic intracerebral hemorrhage, all-cause mortality and severe bleeding events).

This trial provides crucial evidence on whether early intravenous tirofiban with sequential DAPT offers superior benefits over standard care in patients with mild AIS, potentially guiding future antithrombotic strategies.

ClinicalTrials.gov (NCT07095790).