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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Interventions

  • Drug: tirofiban

Arms, Groups and Cohorts

  • Experimental: half dose tirofiban
    • 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.
  • Active Comparator: recommended-dose Tirofiban
    • 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.
  • Placebo Comparator: none tirofiban
    • Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.

Clinical Trial Outcome Measures

Primary Measures

  • Net Adverse Clinical Events
    • Time Frame: 30 days
    • A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Hospital of Jilin University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Liu Bin, M.D., Principal Investigator, Jilin University
  • Overall Contact(s)
    • Liu Bin, M.D., +86 13500810268, liubin3333@vip.sina.com

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