A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 18,624
- 试验地点
- 1
- 主要终点
- Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
研究概览
简要总结
Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
- •Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception
排除标准
- •Persons with moderate or severe liver disease
- •Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
- •Persons who are being treated with blood clotting agents that cannot be stopped
研究组 & 干预措施
Clopidogrel
Oral treatment
干预措施: Clopidogrel (Drug)
Ticagrelor
Oral treatment
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
时间窗: Randomization up to 12 months
Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Participants With Any Major Bleeding Event
时间窗: First dosing up to 12 months
Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee.
次要结局
- Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization(Randomization up to 12 months)
- Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke(Randomization up to 12 months)
- Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.(Randomization up to 12 months)
- Participants With MI Event(Randomization up to 12 months)
- Participants With Death From Vascular Causes(Randomization up to 12 months)
- Participants With Stroke(Randomization up to 12 months)
- Participants With Death From Any Cause(Randomization up to 12 months)
- Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding(First dosing up to 12 months)
- Participants With Major or Minor Bleeding(First dosing up to 12 months)
- Participants With Non-procedural Major Bleeding(First dosing up to 12 months)
- Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding(First dosing up to 12 months)
- Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding(First dosing up to 12 months)
- Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization(1-week period following randomization)
- Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization(1-week period following randomization)