A Phase 4 interventional study of Tirofiban+Oral Dual Antiplatelet Therapy and Oral Dual Antiplatelet Therapy in Mild Stroke, sponsored by Second Affiliated Hospital of Soochow University. Recruiting at 18 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Second Affiliated Hospital of Soochow University · Phase 4, Interventional, and Treatment
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.
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.
Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive tirofiban in the first 48 hours and then be switched to oral dual antiplatelet therapy thereafter
Drug: Tirofiban+Oral Dual Antiplatelet Therapy
Patients will receive oral dual antiplatelet therapy alone
Drug: Oral Dual Antiplatelet Therapy
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)
Also known as: Tirofiban with Sequential Dual Antiplatelet Therapy
Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)
Also known as: Dual Antiplatelet Therapy, Aspirin plus Clopidogrel
Proportion of excellent functional outcomes (mRS 0-1)
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)
Time frame: 90 days
Incidence of early neurological deterioration
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.
Time frame: 72 hours
Incidence of early neurological improvement
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
Time frame: 72 hours
Change in National Institutes of Health Stroke Scale score 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
Time frame: 7 days
Proportion of good functional outcomes (mRS 0-2)
good functional outcomes (mRS 0-2)
Time frame: 90 days
Distribution of mRS scores
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)
Time frame: 90 days
Incidence of schemic stroke
new schemic stroke
Time frame: 90 days
Incidence of major adverse cardiovascular events
including ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, and vascular death
Time frame: 90 days
Rate of symptomatic intracerebral hemorrhage
Symptomatic intracranial hemorrhage is defined according to the ECASS Classification
Time frame: 7 days
Rate of all-cause mortality
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).
Time frame: 90 days
Rate of major bleeding events
defined by the GUSTO bleeding criteria
Time frame: 90 days
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Plan to share: No
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Second Affiliated Hospital of Soochow University