Randomized Controlled Clinical Study to Compare the Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Net Adverse Clinical Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: tirofiban (Drug)
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.
干预措施: tirofiban (Drug)
none tirofiban
Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.
干预措施: tirofiban (Drug)
结局指标
主要结局
Net Adverse Clinical Events
时间窗: 30 days
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
次要结局
- Net adverse clinical events(1 year)
- any bleedings (BARC class)(30 days)
- Major adverse cardiac and cerebral events (MACCE)(30 days and 1 year)
- stent thrombosis(30 days and 1 year)