NCT07760922Not yet recruitingPhase 4
Tirofiban Combined With Aspirin in Moderate Ischemic Stroke
Efficacy and Safety of Tirofiban Combined With Aspirin in Moderate Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1168 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Diseases
- Stroke
- NCT number
- NCT07760922
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1168
- From Oct 2026 to the primary completion date, Dec 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Lab values
- 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;
Other
- Pregnancy or lactation;
- Participation in another clinical trial;
- Expected inability to complete follow-up.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The First People's Hospital of Jingdezhen City Coordinator of this site? Confirm its status | Jingdezhen | China | Unknown status |
| The First People's Hospital of Jiujiang City Coordinator of this site? Confirm its status | Jiujiang | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital of Gannan Medical University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.