Mild Stroke
Conditions
Keywords
Tirofiban; Dual Antiplatelet Therapy; Mild Stroke
Brief summary
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.
Detailed 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.
Interventions
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 47.5 hours; sequential Oral Dual Antiplatelet Therapy (Aspirin 100mg qd; Clopidogrel 75mg qd)
DRUGOral Dual Antiplatelet Therapy
Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)
Sponsors
Second Affiliated Hospital of Soochow University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of excellent functional outcomes (mRS 0-1) | 90 days | The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of early neurological improvement | 72 hours | National Institutes of Health Stroke Scale score of 0 or improvement ≥2 points from baseline. National Institutes of Health Stroke Scale: stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms |
| Change in National Institutes of Health Stroke Scale score from baseline | 7 days | National Institutes of Health Stroke Scale: stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms |
| Proportion of good functional outcomes (mRS 0-2) | 90 days | good functional outcomes (mRS 0-2) |
| Distribution of mRS scores | 90 days | The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death) |
| Incidence of early neurological deterioration | 72 hours | more than 2 National Institutes of Health Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline. National Institutes of Health Stroke Scale: stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms. |
| Incidence of major adverse cardiovascular events | 90 days | including ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, and vascular death |
| Rate of symptomatic intracerebral hemorrhage | 7 days | Symptomatic intracranial hemorrhage is defined according to the ECASS Classification |
| Rate of all-cause mortality | 90 days | The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death). |
| Rate of major bleeding events | 90 days | defined by the GUSTO bleeding criteria |
| Incidence of schemic stroke | 90 days | new schemic stroke |
Countries
China
Contacts
Primary ContactJijun Shi, M.D
Backup ContactYongjun Cao, M.D, PhD
Outcome results
None listed