NCT00994292已完成2 期
A Randomized, Double-Blind, Placebo Controlled Multi-Center and Parallel Group Study of the Safety, Tolerability and Efficacy of YM150 in Combination With Standard Treatment in Secondary Prevention of Ischemic Vascular Events in Subjects With Acute Coronary Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,276
- 主要终点
- Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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
- •has a diagnosis of STE-ACS, NSTE-ACS as index event according to accepted guidelines such as the ESC or AHA guidelines
- •has elevated cardiac biomarkers
排除标准
- •is planned for myocardial revascularization (e.g., Coronary Artery Bypass Graft (CABG) or elective or staged PCI) or any other invasive procedure with increased risk for bleeding (i.e. elective surgical procedures) within 60 days after randomization
- •has had recent stroke or TIA ≤ 12 months prior to index event
- •has persistent BP of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication
- •has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study
- •has participated in any YM150 clinical trials
- •requires ongoing parenteral or oral anticoagulant therapy
- •has active bleeding or is in the opinion of the investigator at high risk of bleeding during the study
研究组 & 干预措施
1. YM150 Dose V, twice daily
Experimental
干预措施: YM150 (Drug)
2. YM150 Dose W, once daily
Experimental
干预措施: YM150 (Drug)
3. YM150 Dose X, twice daily
Experimental
干预措施: YM150 (Drug)
4. YM150 Dose Y, once daily
Experimental
干预措施: YM150 (Drug)
5. YM150 Dose Y, twice daily
Experimental
干预措施: YM150 (Drug)
6. YM150 Dose Z, once daily
Experimental
干预措施: YM150 (Drug)
7. Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition
时间窗: 6 Months
次要结局
- Incidence of Major and Clinically Relevant Non Major bleeding events(30 Days)
研究者
相似试验
已完成
2 期
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement SurgeryArthroplasty, Replacement, HipVenous ThromboembolismNCT00902928Astellas Pharma Europe B.V.1,992
已完成
3 期
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal SurgeryVenous ThromboembolismNCT00942435Astellas Pharma Inc156
已完成
2 期
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial FibrillationAtrial FibrillationNCT00938730Astellas Pharma Inc1,280
已完成
2 期
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement SurgeryVenous ThromboembolismNCT00917254Astellas Pharma Inc369
已完成
2 期
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement SurgeryVenous ThromboembolismNCT00913120Astellas Pharma Inc610