NCT07095790RecruitingPhase 4
Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke
Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 580 (estimated)
- First submitted
- 13 Jul 2025
- Start date
- 30 Aug 2025
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Diseases
- Stroke
- NCT number
- NCT07095790
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 580
- From 30 Aug 2025 to the primary completion date, 28 Feb 2027
- 18 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
- Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
- Major surgery within 14 days.
Other illness
- Intracranial hemorrhage confirmed by imaging.
- Pre-stroke modified Rankin Scale (mRS) score ≥2.
- History of primary intracerebral hemorrhage.
- History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
- Major systemic bleeding within 30 days.
- Known allergy or contraindication to tirofiban or aspirin.
- Any terminal illness with life expectancy \<6 months.
Lab values
- Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \<30%.
- Active bleeding, including laboratory evidence of coagulopathy (platelet count \<100 × 10⁹/L, activated partial thromboplastin time \>50 seconds, or international normalized ratio \>1.7), or treatment with direct oral anticoagulants within the preceding 48 hours.
- Baseline platelet count \<100 × 10⁹/L.
- Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]).
Other
- Untreated or inadequately treated intracranial aneurysm or vascular malformation.
- Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment.
- Current pregnancy or lactation.
- Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).
Who the study is looking for
- Age: 18-80 years old.
- Acute mild non-cardioembolic stroke.
- NIHSS score ≤5.
- Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.
- The investigational drug can be administered within 48 hours of symptom onset.
- Signed informed consent by the patient or legally authorized representative.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| WuYuan County People's Hospital Coordinator of this site? Confirm its status | Bayan Nur | China | Recruiting |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Jiangsu Province (Suqian)Hospital Coordinator of this site? Confirm its status | Suqian | China | Recruiting |
| Zhangjiagang Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Affiliated Jiangsu Shengze Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| First People's Hospital of Kunshan Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Changshu No.1 People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Suzhou Municipal Hospital of Anhui Province Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Suzhou Ninth People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Suzhou Xiangcheng People's Hospital Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Taixing Second People's Hospital Coordinator of this site? Confirm its status | Taizhou | China | Recruiting |
| Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Nuclear Industry 417 Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| First People's Hospital of Xianyang Coordinator of this site? Confirm its status | Xianyang | China | Recruiting |
| Taikang Xian People's Hospital Coordinator of this site? Confirm its status | Zhoukou | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.