A Double-Blind, Randomized, Multicenter, Dose-Ranging Trial of CS-747 Compared With Clopidogrel in Subjects Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 905
- 试验地点
- 2
- 主要终点
- Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
研究概览
简要总结
The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be candidates for elective or urgent PCI with intended coronary stenting.
- •Men or non-pregnant women (that is, postmenopausal women, women who are surgically sterile, or women of childbearing potential who have a negative urine or serum pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years of age.
排除标准
- •Patients must not have planned PCI procedure as initial treatment for an acute ST-elevation acute myocardial infarction (STEMI)
- •Patients must not be receiving or will receive oral anticoagulation therapy that cannot be safely discontinued for the duration of the study
- •Patients must not have cardiogenic shock or severe congestive heart failure
- •Patients must not have active internal bleeding or history of bleeding diathesis
- •Patients must not have prior history of hemorrhagic cerebrovascular accident (CVA) or nonhemorrhagic CVA within 2 years of enrollment
研究组 & 干预措施
Prasugrel (CS-747) 40 mg LD/7.5 mg MD
Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
干预措施: Prasugrel (CS-747) (Drug)
Prasugrel (CS-747) 60 mg LD/10 mg MD
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
干预措施: Prasugrel (CS-747) (Drug)
Prasugrel (CS-747) 60 mg LD/15 mg MD
Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
干预措施: Prasugrel (CS-747) (Drug)
Clopidogrel
Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events
时间窗: randomization though 30 days after percutaneous coronary intervention (PCI)
Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding. A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a \>5 g/dL decrease in hemoglobin. A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease \>=3 g/dL and \<= 5 g/dL.
次要结局
- Number of Participants With Major Adverse Cardiovascular Events (MACE)(randomization though 30 days after percutaneous coronary intervention (PCI))
- Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding(randomization though 30 days after percutaneous coronary intervention (PCI))
- Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE(randomization though 30 days after percutaneous coronary intervention (PCI))