ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

Stopped early · Phase 3

Conditions studied: Peripheral Endovascular Interventions, Bleeding

In brief

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.

Key facts

Study ID

NCT01913483

Run by

The Medicines Company

People needed

732

Starts

2013-09-24

Expected to finish

2016-03-16

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tri-Lakes Research — Hot Springs, Arkansas, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Clearwater Cardiovascular and Interventional Consultants — Clearwater, Florida, United States
• Florida Research Network — Gainesville, Florida, United States
• The Cardiac and Vascular Institute — Gainesville, Florida, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Peoria Radiology Research & Education Foundation — Peoria, Illinois, United States
• Midwest Cardiovascular Research Foundation — Davenport, Iowa, United States
• Kentucky Heart Foundation - King's Daughters Medical Center — Ashland, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• VA Boston Healthcare System — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Cape Cod Research Institute — Hyannis, Massachusetts, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• Weill Cornell Medical College — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Stony Brook Medicine — Stony Brook, New York, United States
• Novant Health Heart and Vascular Institute — Charlotte, North Carolina, United States
• LeBauer Cardiovascular Research Foundation — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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