Tirofiban for Patients Treated With Alteplase

Study Overview
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Brief Summary
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After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.

Official Title
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A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Early Administration of Tirofiban in Acute Ischemic Stroke Patients Treated With Intravenous Alteplase Thrombolysis

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Tirofiban
* Drug: Alteplase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines. 6≤ NIHSS ≤20 before IV tPA, or NIHSS >20 but decrease ≥ 8 after IV rt-PA. ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form Exclusion Criteria: Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines. Patients had used antiplatelet therapy in the past 5 days before the stroke. Patients had used anticoagulant therapy in the past 5 days before the stroke. Scheduled for surgery or interventional treatment requiring study drug cessation. CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory. Any evidence of clinically significant bleeding ,or known coagulopathy. Renal insufficiency (creatinine clearance rate <30ml/min) Hepatic dysfunction (ALT >2 folds of Upper limit of normal value or AST>2 folds of Upper limit of normal value). Pre-existing disability with ≥ mRS 2. Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist. Severe non-cerebrovascular disease with life expectancy <3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirofiban and alteplase<br> | Drug: Tirofiban<br>* Tirofiban Injection after the alteplase intravenous thrombolysis<br>|
| Placebo Comparator: Alteplase<br> | Drug: Alteplase<br>* Only alteplase intravenous thrombolysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of favorable outcome | favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRS ≤2 |  | 90 days | 
| NIHSS score |  | 7 days | 
| Deterioration after improvement |  | 24 hours | 
| Final infarct size |  | 24 hours |