A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 42
- 主要终点
- The composite incidence of major and minor bleeding
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.
详细描述
Primary Outcome Bleeding Secondary Outcome Ischemia
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization;
- •At least one of the following criteria are met:
- •New or presumably new ST-segment depression of at least 1 mm or transient (30 minutes) ST-segment elevation of at least 1 mm in 2 contiguous leads;
- •Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
- •Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction
排除标准
- •Acute ST-segment elevation myocardial infarct
- •Anticipated inability to perform angiography within 24 hours of dosing
- •Evidence of clinical instability
- •Contraindications to anticoagulant use
- •Recent cardiac intervention
- •Clinically abnormal laboratory or test findings during screening
- •Subject is pregnant or lactating
研究组 & 干预措施
REG1-a
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
干预措施: REG1 (Drug)
REG1-b
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
干预措施: REG1 (Drug)
REG1-c
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
干预措施: REG1 (Drug)
REG1-d
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
干预措施: REG1 (Drug)
Heparin
Heparin per standard of care at the local institution
干预措施: Heparin (Drug)
结局指标
主要结局
The composite incidence of major and minor bleeding
时间窗: Through Day 30
次要结局
未报告次要终点