Pharmacodynamic Effects of Ticagrelor and Eptifibatide Bolus-Only Versus Ticagrelor and Eptifibatide Bolus Plus Abbreviated Infusion in Patients Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Percent Inhibition of Platelet Aggregation (%IPA)
研究概览
简要总结
This purpose of this study is to measure platelet response to ticagrelor and eptifibatide bolus-only compared with ticagrelor and eptifibatide bolus plus 2-hour infusion administrated after cardiac catheterization in patients undergoing non-emergent percutaneous coronary intervention.
详细描述
In this study, 70 patients with Acute Coronary Syndrome who are undergoing non-emergent percutaneous coronary intervention (PCI) will be randomized to ticagrelor loading dose and eptifibatide bolus-only versus ticagrelor loading dose and eptifibatide bolus plus 2 hour infusion administrated after cardiac catheterization, but before PCI. Platelet function testing will be performed at baseline and follow-up.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For inclusion in the study subjects should fulfill the following criteria:
- •Provision of informed consent prior to any study specific procedures
- •Males and females aged 19 years and older
- •Congruent to the PLATO trial, at least two of the following three criteria have to be met:
- •ST-segment changes on electrocardiography, indicating ischemia; (In electrocardiography, the ST segment connects the QRS complex and the T wave and has a duration of 0.080 to 0.120 sec (80 to 120 ms).
- •a positive test of a biomarker, indicating 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).
- •patients with symptoms of unstable angina lasting ≥10 min and either an elevated troponin I level or newly developed ST-segment depression of 1 mm or transient ST-segment elevation of 1 mm will also be included.
排除标准
- •Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- •Patients with active pathological bleeding or a history of intracranial bleeding;
- •patients with planned to urgent coronary artery bypass graft surgery;
- •severe hepatic impairment;
- •concomitant therapy with a strong cytochrome P-450 3A inhibitors, where 3A is s subfamily of the cytochrome P450 superfamily of genes;
- •surgery<4 weeks;
- •the use of any thienopyridine (within the previous two weeks);
- •upstream use of Glycoprotein (GP) IIb/IIIa inhibitors;
- •bleeding diathesis or major bleeding episode within 2 weeks;
- •a need for oral anticoagulation therapy;
- •thrombocytopenia;
- •presence of thrombus in the coronary artery; incessant chest pain or hemodynamic instability;
- •and patients with glomerular filtration rate (GFR)<30 mL/min or on hemodialysis.
- •maintenance dose of aspirin above 100mg
- •history of allergies to Ticagrelor
- •patients at increased risk of bradycardic events (e.g., patients who have sick sinus syndrome, 2nd or 3rd degree Atrioventricular block (AV block), or bradycardic related syncope and not protected with a pacemaker
- •women who are pregnant or breastfeeding
研究组 & 干预措施
Ticagrelor and Eptifibatide bolus
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
干预措施: Eptifibatide (Drug)
Ticagrelor & Eptifibatide bolus+infusion
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
干预措施: Ticagrelor (Drug)
Ticagrelor and Eptifibatide bolus
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)
干预措施: Ticagrelor (Drug)
Ticagrelor & Eptifibatide bolus+infusion
Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)
干预措施: Eptifibatide (Drug)
结局指标
主要结局
Change in Percent Inhibition of Platelet Aggregation (%IPA)
时间窗: Baseline and 2 hours
Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.
次要结局
- Bleeding Complications(up to 24 hours)
- Periprocedural Myocardial Infarction (PMI)(Up to 24 hours)
- High On-treatment Platelet Reactivity (HPR)(Comparing baseline and follow-up (2 hours))
研究者
Massoud Leesar
MD, Professor of Medicine
University of Alabama at Birmingham