A Phase IV, Randomised, Multi-Centre, Open Label Study, Comparing Ticagrelor Versus Clopidogrel in Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Patients Undergoing Percutaneous Coronary Intervention (PCI) With Bivalirudin
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
研究概览
简要总结
The purpose of this study is to determine if ticagrelor is as effective as clopidogrel in rate of onset and degree of platelet inhibition for patients with non-ST elevation of acute coronary syndrome (NSTE-ACS) undergoing ad hoc percutaneous coronary intervention (PCI) with bivalirudin.
详细描述
Multi-center, open-label study that will compare the onset of the platelet inhibition with ticagrelor versus clopidogrel when administered with bivalirudin during PCI on a background therapy of aspirin in patients with NSTE-ACS.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalised for chest pain and potential acute coronary syndrome.
- •Onset of the most recent cardiac ischemic symptoms must occur within 7 days before randomisation and documented by cardiac ischemic symptoms of ≥ 10 min duration at rest and at least 2 of the following: ST segment changes on electrocardiogram (ECG) indicative of ischemia, or Positive biomarker evdience of myocardial necrosis, or other risk factors such as: 60 yrs of age or older, previous myocardial infarction or coronary bypass surgery, multi-vessel coronary artery disease, diabetes mellitus, peripheral arterial disease, chronic renal disfunction.
- •Females must be either surgically sterile or post-menopausal.
- •Activated Clotting Time (ACT) </= 300 at the time of study treatment
排除标准
- •Participation in another clinical study with an investigational product during the last 30 days.
- •Current acute complication of percutaneous coronary intervention or coronary bypass surgery.
- •Any contraindication to ticagrelor, clopidogrel or bivalirudin.
- •ST elevation myocardial infraction within 24 hours of study entry.
- •Any indications for oral anticoagulation or aspirin dose other than 75 to 100 milligrams (mg) daily.
- •Planned use of omeprazole or esomeprazole.
- •Patients with known bleeding or coagulation disorders; patients requiring dialysis; patients who have an inability to swallow medication.
- •Patients with known bleeding diathesis or coagulation disorder; history of intracranial bleed.
- •Use of Intravenous (IV) heparin less than 2 hours before procedure.
- •Sustained uncontrolled high blood pressure
研究组 & 干预措施
Ticagrelor
90 mg oral tablet
干预措施: ticagrelor (Drug)
Clopidogrel
300 mg oral tablet
干预措施: clopidogrel (Drug)
结局指标
主要结局
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose
时间窗: 0.5 hours post loading dose
PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose
时间窗: 1 hour post loading dose
PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus
次要结局
未报告次要终点