Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
- Registration Number
- NCT02294994
- Lead Sponsor
- Second Hospital of Jilin University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description half dose tirofiban 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. recommended-dose Tirofiban 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. none tirofiban tirofiban Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.
- Primary Outcome Measures
Name Time Method Net Adverse Clinical Events 30 days A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
- Secondary Outcome Measures
Name Time Method Net adverse clinical events 1 year a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
any bleedings (BARC class) 30 days including all BARC class (class 1-5)
Major adverse cardiac and cerebral events (MACCE) 30 days and 1 year a composite of all cause death, reinfarction, target vessel revascularization or stroke
stent thrombosis 30 days and 1 year by ARC definition
Trial Locations
- Locations (1)
The sencond hospital of Jilin University
🇨🇳Changchun, Jilin, China