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Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

NCT07760922 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1168

Last updated 2026-08-12

No results posted yet for this 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.

Conditions

  • Ischemic Stroke, Acute

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Xinqiao Hospital of Chongqing

    lead OTHER

Principal Investigators

  • Zhongming Qiu · Xinqiao Hospital of the Army Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760922 on ClinicalTrials.gov