Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,011
- 试验地点
- 1
- 主要终点
- occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
研究概览
简要总结
A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will be followed for one year for outcomes such as bleeding episode requiring medical intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding).
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 70 years of age.
- •Hospitalization for NSTEMI or UA < 72 hours
排除标准
- •Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor:
- •Unable or unwilling to give informed consent or have a life expectancy of less than one year.
- •Having received thrombolytic therapy within the previous 24 hours.
- •Severe renal function impairment needing dialysis.
- •Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization.
- •At increased bleeding risk, at the investigator's opinion, e.g. because of malignancy.
- •Cardiogenic shock (SBP ≤ 80mmHg for >30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening.
- •History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
- •Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion.
- •ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor.
- •Patients with a known CYP2C19 genotype at the time of randomization.
研究组 & 干预措施
Intervention
Clopidogrel
干预措施: Clopidogrel (Drug)
Control
Ticagrelor/Prasugrel
干预措施: Ticagrelor or Prasugrel (Drug)
结局指标
主要结局
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
时间窗: One year
net clinical benefit at 1 year after randomisation
时间窗: One year
All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding
次要结局
未报告次要终点
研究者
Jurriën M. ten Berg, MD, PhD
MD, PhD
St. Antonius Hospital