ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
- Conditions
- Peripheral Endovascular InterventionsBleeding
- Interventions
- Registration Number
- NCT01913483
- Lead Sponsor
- The Medicines Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 732
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bivalirudin 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 \[mL/min\]). Unfractionated Heparin 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.
- Primary Outcome Measures
Name Time Method 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) 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.
- Secondary Outcome Measures
Name Time Method 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 Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).
In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30 Study drug initiation (Day 1) up to 30 days Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.
In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation.
Trial Locations
- Locations (39)
Clearwater Cardiovascular and Interventional Consultants
🇺🇸Clearwater, Florida, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Peoria Radiology Research & Education Foundation
🇺🇸Peoria, Illinois, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Baptist Cardiac & Vascular Institute
🇺🇸Miami, Florida, United States
Tri-Lakes Research
🇺🇸Hot Springs, Arkansas, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Florida Research Network
🇺🇸Gainesville, Florida, United States
Cape Cod Research Institute
🇺🇸Hyannis, Massachusetts, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Integris - Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Alpine Research
🇺🇸Ogden, Utah, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
The Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Kentucky Heart Foundation - King's Daughters Medical Center
🇺🇸Ashland, Kentucky, United States
VA Boston Healthcare System
🇺🇸Boston, Massachusetts, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
INOVA Alexandria Hospital
🇺🇸Alexandria, Virginia, United States
LeBauer Cardiovascular Research Foundation
🇺🇸Greensboro, North Carolina, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Novant Health Heart and Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Scott and White Hospital
🇺🇸Temple, Texas, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Jobst Vascular Institute
🇺🇸Toledo, Ohio, United States
Texas Tech University Health Science Center
🇺🇸Lubbock, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States