Tirofiban with aspirin tested in moderate ischemic stroke
Tests tirofiban plus aspirin against placebo plus aspirin in adults with moderate ischemic stroke.
Plain-language title generated from the registry record
Registry title: Tirofiban Combined With Aspirin in Moderate Ischemic Stroke
Key facts
- Where
- Haikou, Jingdezhen, Jiujiang, and Nanchang, ChinaSee the 5 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07760922, who can take part
Where in China
- The First Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaNo longer taking part
- The First People's Hospital of Jingdezhen CityJingdezhen, ChinaNo longer taking part
- The First People's Hospital of Jiujiang CityJiujiang, ChinaNo longer taking part
- The First Affiliated Hospital of Gannan Medical UniversityNanchang, ChinaNo longer taking part
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xinqiao Hospital of Chongqing
- Trial code
- NCT07760922
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Tirofiban Combined With Aspirin in Moderate Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
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.
Inclusion: Age 18-80 years; Acute ischemic stroke; time from last known well to randomization ≤ 24 hours; Pre-randomization NIHSS score 4-10, with at least one of item 5 (upper limb) or item 6 (lower limb) ≥ 1; Pre-stroke modified Rankin Scale (mRS) ≤ 1; Written informed consent provided by the patient or a legally authorized representative.
Exclusion: Has received or is planned to receive reperfusion therapy (thrombolysis or endovascular treatment); Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months; Planned surgery or intervention requiring discontinuation of antiplatelet therapy; Prior non-atherosclerotic arterial disease, including moyamoya disease, arterial dissection, fibromuscular dysplasia; Prior neurologic or psychiatric disease that would interfere with neurologic assessment; Intracranial hemorrhage confirmed by CT or MRI; Definite indication for anticoagulation (atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism); Severe systemic disease (e.g., severe infection, severe hepatic or renal dysfunction); Allergy to tirofiban and/or aspirin; History of intracranial hemorrhage; Gastrointestinal bleeding or major surgery within the past 3 months; Stroke caused by angiography or surgery; Other structural brain disease (vascular malformation, tumor, abscess, multiple sclerosis, etc.) confirmed by CT/MRI; Advanced disease with expected survival < 6 months; 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%; Planned use of NSAIDs affecting platelet function; Pregnancy or lactation; Participation in another clinical trial; Expected inability to complete follow-up.