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NCT07760922

PHASE4

Tirofiban Combined With Aspirin in Moderate Ischemic Stroke

Sponsor: Xinqiao Hospital of Chongqing

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Tirofiban Combined With Aspirin in Moderate Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1168

Start Date

2026-10-01

Completion Date

2028-12-31

Last Updated

2026-08-12

Healthy Volunteers

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.

Inclusion Criteria: 1. Age 18-80 years; 2. Acute ischemic stroke; time from last known well to randomization ≤ 24 hours; 3. Pre-randomization NIHSS score 4-10, with at least one of item 5 (upper limb) or item 6 (lower limb) ≥ 1; 4. Pre-stroke modified Rankin Scale (mRS) ≤ 1; 5. Written informed consent provided by the patient or a legally authorized representative. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT or MRI; 2. Has received or is planned to receive reperfusion therapy (thrombolysis or endovascular treatment); 3. Any definite cardioembolic source: chronic/paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \< 30%; 4. Definite indication for anticoagulation (atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism); 5. Severe systemic disease (e.g., severe infection, severe hepatic or renal dysfunction); 6. Allergy to tirofiban and/or aspirin; 7. History of intracranial hemorrhage; 8. Planned use of NSAIDs affecting platelet function; 9. Gastrointestinal bleeding or major surgery within the past 3 months; 10. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months; 11. Planned surgery or intervention requiring discontinuation of antiplatelet therapy; 12. Stroke caused by angiography or surgery; 13. Prior non-atherosclerotic arterial disease, including moyamoya disease, arterial dissection, fibromuscular dysplasia; 14. Other structural brain disease (vascular malformation, tumor, abscess, multiple sclerosis, etc.) confirmed by CT/MRI; 15. Pregnancy or lactation; 16. Prior neurologic or psychiatric disease that would interfere with neurologic assessment; 17. Participation in another clinical trial; 18. Advanced disease with expected survival \< 6 months; 19. Expected inability to complete follow-up.

Locations (5)

The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

The First People's Hospital of Jingdezhen City

Jingdezhen, Jiangxi, China

The First People's Hospital of Jiujiang City

Jiujiang, Jiangxi, China

The First Affiliated Hospital of Gannan Medical University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University