A Randomized, Open-label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 503
- 试验地点
- 44
- 主要终点
- Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.
研究概览
简要总结
The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).
The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus.
Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 19 years
- •Ability to give informed consent
- •Documented stable CAD with a significant lesion in a native coronary artery amenable to PCI with one stent
- •Planned single vessel intervention
排除标准
- •Myocardial infarction or unstable angina within the prior 7 days
- •Target lesion is a chronic total occlusion (present for longer than 3 months)
- •Target lesion with angiographically visible thrombus or in-stent thrombosis
- •Target lesion is in a bypass graft
- •Planned use of a GP IIb/IIIa inhibitor or planned use of atherectomy including directional, rotational, or laser
- •Known allergies or sensitivities to heparin, pork, or pork-containing products
- •History of HIT
- •Hemodynamic instability
- •Stroke or Transient Ischemic Attack (TIA) in the prior 3 months
- •Active bleeding or bleeding diathesis
- •Trauma or major surgery in the preceding month or planned surgery or PCI within the 30 days after the index PCI
- •Suspected aortic dissection
- •Receiving oral anticoagulation therapy
- •Receipt of LMWH or of UFH (except for that used during the diagnostic portion of the index procedure) within the prior 7 days
- •ACT > 200 prior to study drug administration
- •Severe, untreated hypertension at the time of the index PCI procedure (systolic blood pressure of > 180 mm Hg, diastolic blood pressure > 90 mm Hg)
- •Hemoglobin level of less than 10.0 g/dl or a hematocrit below 30%
- •Platelet count of less than 100,000 per cubic millimeter or more than 600,000 per cubic millimeter
- •Creatinine clearance < 30 mL/min
- •Any malignancy within the prior 5 years with the exception of non-melanoma skin cancers
- •Prior enrollment in EMINENCE trial or currently receiving other experimental therapy
- •Pregnant or lactating if subject is female
- •Ability to give informed consent
- •Participation in the main study protocol
- •Inability to provide the blood specimens required by the substudy protocol
研究组 & 干预措施
70 U/kg of unfractionated heparin given IV
Venous injection (IV) of 70 units per kilogram (U/kg) of unfractionated heparin prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
干预措施: Unfractionated Heparin (Drug)
50 IU/KG of M118
Venous injection of 50 international units per kilogram (IU/kg) of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
干预措施: M118 (Drug)
75 IU/KG of M118
Venous injection of 75 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
干预措施: M118 (Drug)
100 IU/KG of M118
Venous injection of 100 IU/kg of M118 prior to percutaneous coronary intervention. If procedure lasts longer than 30 minutes a 1/2 rebolus of the original therapy will be given.
干预措施: M118 (Drug)
结局指标
主要结局
Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.
时间窗: 30 days
次要结局
未报告次要终点