Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke (TiMIS)

Soochow University

Status and phase: Enrolling; Phase 4

Conditions: Mild Stroke

Treatments: Drug: Tirofiban+Oral Dual Antiplatelet Therapy; Drug: Oral Dual Antiplatelet Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07095790

LK2025063

2024yb48 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Although dual antiplatelet therapy (DAPT) reduces stroke recurrence and disability risks, its efficacy is limited in patients with mild ischemic stroke (NIHSS ≤5), among whom early neurological deterioration (END) and poor functional outcomes are frequently observed. Notably, intravenous thrombolysis is not more effective than DAPT for mild stroke management. Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has shown potential efficacy in mild-to-moderate ischemic stroke, but robust evidence specific to mild stroke remains lacking. 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.

Enrollment: 580 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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580 participants in 2 patient groups

Tirofiban+Oral Dual Antiplatelet Therapy

Experimental group

Description:

Patients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter

Treatment:

Drug: Tirofiban+Oral Dual Antiplatelet Therapy

oral dual antiplatelet therapy

Active Comparator group

Description:

Patients will receive oral dual antiplatelet therapy alone

Treatment:

Drug: Oral Dual Antiplatelet Therapy