ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 732
- 试验地点
- 39
- 主要终点
- Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
研究概览
简要总结
The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥ 18 years of age
- •Must be undergoing one of the following PEI procedures:
- •Carotid artery stenting
- •Lower Extremity Interventions (LEI) for Critical Limb Ischemia
- •LEI for claudication
- •Provide written informed consent prior to any study-specific procedure being performed
排除标准
- •Any known contra-indication to the use of bivalirudin or UFH
- •Acute limb ischemia
- •Planned amputation regardless of the outcome of the PEI
- •Dialysis dependent
- •Weight less than 38 kg or more than 202 kg
- •History of any bleeding diathesis or severe hematological disease
- •History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage
- •Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization
- •Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization
- •Concomitant percutaneous coronary intervention
- •Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization
- •International normalized ratio >1.7 within 24 h prior to the index procedure
- •Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to the intervention)
- •Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure
- •Severe contrast allergy that cannot be pre-medicated
- •Procedures performed by radial access when they are intended as the primary access site for the index procedure
- •Known or suspected pregnant women or nursing mothers
- •Previous enrollment in this study (MDCO-BIV-12-03)
- •Participation in other investigational drug or device trials within 30 days prior to randomization
- •Participants who, for any reason, are deemed by the investigator to be inappropriate for this study
研究组 & 干预措施
Bivalirudin
Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters/minute [mL/min]).
干预措施: Bivalirudin (Drug)
Unfractionated Heparin
UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
干预措施: Unfractionated Heparin (Drug)
结局指标
主要结局
Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
时间窗: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
BARC ≥3 includes: Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision. Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period. Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.
次要结局
- Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration(Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first)
- Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30(Study drug initiation (Day 1) up to 30 days)