Ticagrelor vs. Tirofiban, Comparison of Anti-platelet Effects in Patients With Non-ST Elevation Acute Coronary Syndrome(TE-CLOT Trial : Ticagrelor's Effect for CLOT Prevention) ; A Single Center, Open-label Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage IPA after 20µmol/l ADP at 2 hour
研究概览
简要总结
This is a single-center, open-label prospective randomized pharmacodynamic investigation of two anti platelet regimens in patients who are planned to undergo PCI for non-ST segment elevation acute coronary syndrome(NSTE-ACS) for 24 hours
- Ticagrelor : loading dose(180mg) followed by maintenance dose(90mg bid)
- Tirofiban : 0.4ug/kg/min for 30min followed by 0.1ug/kg/min
- both agents will be given on top of aspirin
详细描述
In combination with aspirin, P2Y12 receptor antagonist or glycoprotein IIb/IIIa inhibitor(GPI) is now a recommended drug as the standard dual antiplatelet regimen in patients with acute coronary syndrome(1).
Ticagrelor is a newly developed oral P2Y12 receptor inhibitor. It shows faster, greater and more consistent platelet inhibition as compared with previous P2Y12 receptor antagonist clopidogrel(2) and it also shows better clinical outcome and similar risk for bleeding as compared with clopidogrel(3).Interestingly, pharmacodynamic data of some studies showed excellent effect of ticagrelor in terms of inhibiting platelet activation apparently as high as that of GPI(2,4).
Primary hypothesis: Ticagrelor have a comparable efficacy in platelet inhibition to GPI in patients with non-ST segment elevation acute coronary syndrome.
Statistical design : non-inferiority test
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 with recent or current ischemic symptoms at the time of randomization will be eligible if 2 of the following criteria are met: ST-T change indicating ischemia; a positive test of biomarker indication myocardial necrosis; or one of several risk factors(age ≥60 years
- •Previous myocardial infarction or coronary artery bypass grafting [CABG]
- •Coronary artery disease with stenosis of ≥50% in at least two vessels
- •Previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization
- •Diabetes mellitus
- •Peripheral arterial disease; or chronic renal dysfunction, defined as a creatinine clearance of <60 ml per minute per 1.73 m2 of body surface area)
排除标准
- •Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current AMI
- •Major surgery or trauma within 30 days
- •Active bleeding
- •Previous stroke in the last six months
- •Oral anticoagulant therapy
- •Pre-existing thrombocytopenia
- •Hypertensive retinopathy
- •Severe hepatic failure
- •Severe renal failure requiring hemodialysis
- •Documented allergy/intolerance or contraindication to tirofiban or P2Y12 inhibitor
- •Uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy)
- •Limited life expectancy, e.g. neoplasms, others
- •Inability to obtain informed consent
研究组 & 干预措施
Ticagrelor
loading dose(180mg) followed by maintenance dose(90mg bid)
干预措施: Ticagrelor (Drug)
Tirofiban
0.4ug/kg/min for 30min followed by 0.1ug/kg/min
干预措施: Tirofiban (Drug)
结局指标
主要结局
Percentage IPA after 20µmol/l ADP at 2 hour
时间窗: 2 hours
Blood samples anticoagulated with 0.129 mol/l sodium citrate will be collected for platelet reactivity. Platelet-rich plasma, obtained by centrifuging whole blood for 15 min at 100 g, will be stimulated with 20 µmol/l ADP and aggregation will be assessed using a light transmittance aggregometer(Chronolog, USA).
次要结局
- Percentage IPA at 8 hours after 20µMol ADP, TRAP, Arachidonic acid, Collagen(24 hours)
- periprocedural bleeding(0~24 hours)
- Peak cardiac enzyme level(0~24 hours)
- Percentage IPA after TRAP, arachidonic acid, collagen at 2 hours(2 hours)
研究者
June Hong Kim
Professor
Pusan National University Yangsan Hospital