Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

Condition(s) studied

Investigational drug(s) / intervention(s)

Tirofiban: Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban after randomization: 0.4 µg/kg/min for the first 30 minutes, then 0.1 µg/kg/min for a total of 24 hours. Plus guideline-based standard care.

Tirofiban-matching placebo: Aspirin 100 mg once daily orally for 90 days, plus immediate intravenous tirofiban-matching placebo infusion (0.4 µg/kg/min × 30 min, then 0.1 µg/kg/min × 24 h). Plus guideline-based standard care.

Study summary

Ischemic stroke accounts for the majority of stroke cases in China, and moderate ischemic stroke (NIHSS 4-10) carries a high risk of early neurologic deterioration (END) and long-term disability. Although intensified antiplatelet strategies reduce END, they have not consistently improved long-term functional outcome. Tirofiban, a selective glycoprotein IIb/IIIa receptor inhibitor, has shown a clinically meaningful trend toward better 90-day functional outcome (mRS 0-1) in prior tirofiban trials, but existing sample sizes were underpowered to detect this difference.

TAMIS is a multicenter, randomized, double-blind, placebo-controlled superiority trial in patients with acute moderate ischemic stroke (NIHSS 4-10) within 24 hours of last known well. Eligible patients are randomized 1:1 to tirofiban plus aspirin versus placebo plus aspirin, both on a background of guideline-based standard medical care. The primary efficacy endpoint is the proportion of patients with an excellent functional outcome (mRS 0-1) at 90 days. The primary safety endpoint is symptomatic intracranial hemorrhage within 48 (±12) hours by the Heidelberg criteria.

Eligibility

Primary outcome measure(s)

• Proportion of patients with mRS 0-1 at 90 days (%) — At 90 days after randomization
  Proportion of patients achieving an excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0 or 1 at 90 days after randomization.
• Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%) — 48 (±12) hours after randomization
  Symptomatic intracranial hemorrhage within 48 (±12) hours (Heidelberg criteria) (%)

Trial sites (5)

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