Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Hospital of Jilin University

About this trial

The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years old;

Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;

Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;

Tirofiban or placebo treatment can be initiated within 6h after IVT;

Disqualifiers

Received or plan to undergo bridge therapy;

Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);

Atrial fibrillation or suspected cardiac embolism;

Accompanied by epileptic seizures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirofiban

    Drug

    Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation

  • Tirofiban simulant

    Drug

    Tirofiban simulant is placebo packed the same style as tirofiban

Treatment groups

1,084 Participants
are divided into 2 treatment groups
Group A: Tirofiban groupActive comparator 1 intervention
Group B: Tirofiban simulant groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients of modified Rankin Scale (mRS)≤1

mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome

Time frame
90±7 days

Secondary outcomes

1

Proportion of patients of mRS≤2

mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome

Time frame
90±7 days
2

Distribution of mRS

mRS depicts functional outcome of stroke, which ranges from 0-6

Time frame
90±7 days
3

National Institute of Health stroke scale (NIHSS)

National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome

Time frame
24 hours after IVT, 7 days

Other outcomes

1

Symptomatic intracranial hemorrhage

Symptomatic intracranial hemorrhage is defined according to the ECASS Classification

Time frame
within 24 hours of completion of study drug infusion, hospitalization
2

Hemorrhagic transformation

defined according to the ECASS Classification

Time frame
24 hours after IVT, hospitalization

Sponsors and contacts

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