EUCTR2009-017242-30-SK进行中（未招募）不适用
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction - PEGASUS - TIMI 54
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men and women =50 years of age.
- •Person who had a heart attack within 1 – 3 years ago and at least one additional risk factor: Age = 65 years old, Diabetes requiring medication, Documented history of 2nd prior MI (>1 year ago). Angiographic evidence of multivessel CAD, and / or Chronic, non-end stage renal dysfunction.
- •Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use medically accepted method of contraception.
- •Patient must be currently taking aspirin, with a planned maintenance dose between 75 and 150 mg once daily.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Persons who are being treated with agents inhibiting blood clotting if the agent cannot be stopped at study start.
- •Persons who have planned coronary, cerebrovascular, or peripheral arterial revascularization (invasive surgery) at study start.
- •Persons with known bleeding disorders.
- •Persons who need chronic oral anticoagulant therapy or chronic lowmolecular-weight heparin.
- •Persons with a history of ischemic stroke.
- •Persons with a history of intracranial bleeding at any time, a tumor or blood vessel abnormality in the brain and/or spinal cord at any time, a history of surgery involving the brain or spinal cord within the last 5
- •years, or a history of bleeding from the gastrointestinal tract (eg, esophagus, stomach, colon, rectum) within the last 6 months or a major surgery within the last 30 days.
- •Persons considered to be at risk of bradycardic events unless already treated with a permanent pacemaker.
- •Persons who have had open heart surgery within the past 5 years, unless the person had a heart attack after the surgery.
- •Persons with known severe liver disease.
- •Persons with kidney failure requiring dialysis.
- •Persons with life expectancy < 1 year.
研究者
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进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction - PEGUSUSMyocardial Infarction, Cardiovascular Death, Atherothrombosis,strokeMedDRA version: 9.1Level: SOCClassification code 10007541EUCTR2009-017242-30-ITASTRAZENECA21,000