Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease

Study Overview
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Brief Summary
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The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.

Official Title
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Randomized Controlled Clinical Study to Compare the Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: tirofiban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI Experienced ischaemic pain at rest Lasting 10 minutes and occurring within 7 days before enrollment As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference - High-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score > 26 and chronic total occlusion disease. Exclusion Criteria: Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm; Recent (<1 month) trauma or major surgery (including bypass surgery); Active bleeding Unexplained clinically significant bleeding, thrombocytopenia (platelet count < 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure > 180 mm Hg despite treatment) Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, - Thrombolytic therapy within preceding 24 hours Receiving antiIIb/IIIa therapy Creatinine clearance of <30 mL/min

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: half dose tirofiban<br>Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI. | Drug: tirofiban<br> <br> * Other names: aggrastat;|
| Active Comparator: recommended-dose Tirofiban<br>Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI. | Drug: tirofiban<br> <br> * Other names: aggrastat;|
| Placebo Comparator: none tirofiban<br>Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI. | Drug: tirofiban<br> <br> * Other names: aggrastat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Adverse Clinical Events | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical events | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings | 1 year | 
| any bleedings (BARC class) | including all BARC class (class 1-5) | 30 days | 
| Major adverse cardiac and cerebral events (MACCE) | a composite of all cause death, reinfarction, target vessel revascularization or stroke | 30 days and 1 year | 
| stent thrombosis | by ARC definition | 30 days and 1 year |