Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT

Detailed Description
-----------------
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size. Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.

Official Title
-----------------
Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: Tirofiban
* Drug: Tirofiban simulant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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; mRS score before onset≤ 1; Intracranial hemorrhage is ruled out by CT head after IVT; Systolic blood pressure before enrollment≤ 160mmHg; Exclusion Criteria: 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; Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment; Active bleeding or tendency to bleed after receipt of intravenous thrombolysis; Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year; Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L； Life expectancy less than 3 months; Pregnant or lactating women; Known allergy to tirofiban; Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.; Patients who are unwilling to be followed up or likely to have poor treatment compliance; Other situations that the researcher deems unsuitable for inclusion in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tirofiban group<br>Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT | Drug: Tirofiban<br>* Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation<br>|
| Placebo Comparator: Tirofiban simulant group<br>Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT | Drug: Tirofiban simulant<br>* Tirofiban simulant is placebo packed the same style as tirofiban<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90±7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients of mRS≤2 | mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome | 90±7 days | 
| Distribution of mRS | mRS depicts functional outcome of stroke, which ranges from 0-6 | 90±7 days | 
| 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 | 24 hours after IVT, 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute ischemic stroke, intravenous thrombolysis, tirofiban