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Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

ConditionMild Stroke
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)

Intracranial hemorrhage confirmed by imaging.

Pre-stroke modified Rankin Scale (mRS) score ≥2.

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%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirofiban+Oral Dual Antiplatelet Therapy

    Drug

    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)

  • Oral Dual Antiplatelet Therapy

    Drug

    Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)

Treatment groups

580 Participants
are divided into 2 treatment groups
Group A: Tirofiban+Oral Dual Antiplatelet TherapyExperimental treatment 1 intervention
Group B: oral dual antiplatelet therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

Proportion of good functional outcomes (mRS 0-2)

good functional outcomes (mRS 0-2)

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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