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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: tirofiban

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130041
      • Recruiting
      • The sencond hospital of Jilin University
      • Contact: Liu Bin, M.D.; Phone Number: +86 13500810268; Email: liubin3333@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: tirofiban; Other Names: GPIIb/IIIa inhibitor; aggrastat
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.	Drug: tirofiban; Other Names: GPIIb/IIIa inhibitor; aggrastat
Placebo Comparator: none tirofiban; Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.	Drug: tirofiban; Other Names: GPIIb/IIIa inhibitor; aggrastat

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Hospital of Jilin University
• Investigators: Principal Investigator: Liu Bin, M.D., Jilin University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 16, 2014
• First Submitted That Met QC Criteria: November 16, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 29, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban
• Other Study ID Numbers: SecondJilinU-1