Tirofiban plus dual antiplatelet therapy for 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

This trial will test whether giving intravenous tirofiban within 48 hours followed by two oral antiplatelet medicines helps adults with mild non‑cardioembolic ischemic stroke (NIHSS ≤5) achieve excellent recovery more often than standard dual antiplatelet therapy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Soochow University (other)
• Locations: 18 sites (Suzhou, Anhui and 17 other locations)
• Trial ID: NCT07095790 on ClinicalTrials.gov

What this trial studies

This randomized interventional phase 4 comparison gives one group a 48‑hour intravenous tirofiban infusion started within 48 hours of symptom onset followed by sequential dual antiplatelet therapy, while the control group receives standard guideline-based oral dual antiplatelet therapy. Participants are adults aged 18–80 with acute mild non‑cardioembolic ischemic stroke (NIHSS ≤5) and no intracranial hemorrhage or major cardioembolic source. The main outcome is the proportion achieving an excellent functional outcome (modified Rankin Scale 0–1). Key exclusions include prior significant disability (pre‑stroke mRS ≥2), planned or received IV thrombolysis or bridging therapy, and confirmed cardioembolic conditions.

Who should consider this trial

Good fit: Adults 18–80 with acute mild non‑cardioembolic ischemic stroke, NIHSS ≤5, able to start the investigational drug within 48 hours of onset, and without intracranial hemorrhage or a cardioembolic source are eligible.

Not a fit: Patients with cardioembolic stroke mechanisms, pre‑existing significant disability (pre‑stroke mRS ≥2), intracranial hemorrhage, those who receive or will receive IV thrombolysis or endovascular bridging therapy, or those presenting beyond 48 hours are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, early short‑term IV tirofiban followed by dual antiplatelet therapy could increase the chance of excellent recovery and reduce early neurological deterioration in patients with mild stroke.

How similar studies have performed: Prior smaller studies and observational data have suggested potential benefit of tirofiban in mild‑to‑moderate ischemic stroke, but robust randomized evidence specifically in mild stroke populations remains limited.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-80 years old.
2. Acute mild non-cardioembolic stroke.
3. NIHSS score ≤5.
4. 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.
5. The investigational drug can be administered within 48 hours of symptom onset.
6. Signed informed consent by the patient or legally authorized representative.

Exclusion Criteria:

1. Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
2. Intracranial hemorrhage confirmed by imaging.
3. Pre-stroke modified Rankin Scale (mRS) score ≥2.
4. 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%.
5. History of primary intracerebral hemorrhage.
6. History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
7. Untreated or inadequately treated intracranial aneurysm or vascular malformation.
8. Major systemic bleeding within 30 days.
9. 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.
10. Major surgery within 14 days.
11. Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment.
12. Baseline platelet count \<100 × 10⁹/L.
13. Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]).
14. Known allergy or contraindication to tirofiban or aspirin.
15. Current pregnancy or lactation.
16. Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).
17. Any terminal illness with life expectancy \<6 months.

Where this trial is running

Suzhou, Anhui and 17 other locations

• Suzhou Municipal Hospital of Anhui Province — Suzhou, Anhui, China (RECRUITING)
• Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• Taikang Xian People's Hospital — Zhoukou, Henan, China (RECRUITING)
• WuYuan County People's Hospital — Bayan Nur, Inner Mongolia, China (RECRUITING)
• Huai'an First People's Hospital — Huai'an, Jiangsu, China (RECRUITING)
• Jiangsu Province (Suqian) Hospital — Suqian, Jiangsu, China (RECRUITING)
• Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)
• Affiliated Jiangsu Shengze Hospital of Nanjing Medical University — Suzhou, Jiangsu, China (RECRUITING)
• Changshu No.1 People's Hospital — Suzhou, Jiangsu, China (RECRUITING)
• First People's Hospital of Kunshan — Suzhou, Jiangsu, China (RECRUITING)
• Suzhou Ninth People's Hospital — Suzhou, Jiangsu, China (RECRUITING)
• Suzhou Xiangcheng People's Hospital — Suzhou, Jiangsu, China (RECRUITING)
• Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine — Suzhou, Jiangsu, China (RECRUITING)
• Zhangjiagang Hospital of Traditional Chinese Medicine — Suzhou, Jiangsu, China (RECRUITING)
• Taixing Second People's Hospital — Taizhou, Jiangsu, China (RECRUITING)
• Nuclear Industry 417 Hospital — Xi'an, Shaanxi, China (RECRUITING)
• First People's Hospital of Xianyang — Xianyang, Shaanxi, China (RECRUITING)
• Second Hospital of Tianjin Medical University — Tianjin, China (RECRUITING)

Study contacts

• Principal investigator: Jijun Shi, M.D — Second Affiliated Hospital of Soochow University
• Study coordinator: Jijun Shi, M.D

Conditions: Mild Stroke, Tirofiban, Dual Antiplatelet Therapy