Phase 2a, Multi-Center, Open Label, Randomized, Feasibility/Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Subjects Undergoing Elective PCI After Pretreatment With Clopidogrel and Aspirin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Major bleeding using the ACUITY bleeding criteria
研究概览
简要总结
The purpose of this study is to determine if it is feasible and safe to use the REG1 Anticoagulation System instead of unfractionated heparin during percutaneous coronary intervention (PCI) in subjects with coronary artery disease (CAD).
详细描述
The study drug, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at high risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.
REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits Factor IXa, a protein critical to blood coagulation. The antidote component, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and rapid reversal of the RB006 effect and allows the patient's blood to return to normal.
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
- None
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
- •Males or females scheduled for non-urgent elective PCI (who do not have certain cardiac parameters) and have not been treated with UHF prior to PCI.
- •Subject able to give informed consent and comply with the protocol.
- •Negative urine pregnancy test or documented surgical sterilization or menopausal.
排除标准
- •Subject weight >120 kg.
- •Recent acute coronary syndrome with elevated cardiac markers or ST segment depression at rest.
- •Evidence of clinical instability
- •Angiographic high-risk.
- •A contraindication to anticoagulation or increased risk of bleeding.
- •Use of prohibited medications or investigational drugs prior to the study.
- •Clinically significant abnormal laboratory findings.
- •Planned use of femoral sheath greater than a certain size.
- •Known allergy or intolerance to drugs mandated by the study.
- •Use of devices other than angioplasty balloons and coronary stents.
- •A history of licit drug abuse or illicit drug use or current evidence of such abuse.
- •Any other factor that the Investigator feels would put the subject at increased risk if participating in the protocol.
- •Lactation.
- •Currently enrolled in this or another clinical trial (with some exceptions).
- •Participation in an investigational drug or device trial in the past 30 days.
研究组 & 干预措施
Unfractionated Heparin
Unfractionated Heparin
干预措施: Unfractionated Heparin (Drug)
REG1 Partial Rev.
REG1 with partial reversal
干预措施: REG1 (Drug)
REG1 Total Rev.
REG1 with total reversal
干预措施: REG1 (Drug)
结局指标
主要结局
Major bleeding using the ACUITY bleeding criteria
时间窗: until hospital discharge or 48 hours whichever occurs first
Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)
时间窗: through Day 14 (+/- 3 days)
次要结局
- Angiographic complications(through Day 14 (+/- 3 days))
- Femoral Sheath Complications(until the sheath is pulled)