ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Medicines Company
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
First received: July 30, 2013
Last updated: July 28, 2014
Last verified: July 2014

The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify 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.

Condition Intervention Phase
Peripheral Endovascular Interventions
Drug: Bivalirudin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

Resource links provided by NLM:

Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • Bleeding [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
    Bleeding defined as Bleeding Academic Research Consortium (BARC) ≥3 within 48 hours post study drug initiation or at hospital discharge, whichever occurs first, as adjudicated by the CEC

Estimated Enrollment: 3900
Study Start Date: September 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bivalirudin
Bivalirudin will be administered as a bolus and infusion. The bolus (0.75 mg/kg) will be administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin will be initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for subjects with an eGFR <30 mL/min).
Drug: Bivalirudin
Active Comparator: Heparin
UFH will be administered as an initial weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses may be administered per the pre-defined heparin dosing algorithm.
Drug: Bivalirudin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects ≥ 18 years of age
  • Must be undergoing one of the following PEI procedures:

    • Carotid artery stenting (approximately 33% of study sample)
    • Lower Extremity Interventions (LEI) for Critical Limb Ischemia (CLI) (approximately 33% of study sample)
    • LEI for claudication (approximately 33% of study sample)
  • Provide written informed consent prior to any study-specific procedure being performed

Exclusion Criteria:

  • 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 kilograms (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 (including biopsy) within the 30 days prior to randomization
  • Concomitant percutaneous coronary intervention (PCI)
  • Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization
  • International normalized ratio (INR) >1.7 within 24 hours (h) prior to the index procedure
  • Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 units (U)] of heparin is permitted during the diagnostic angiogram prior to the intervention)
  • Administration of enoxaparin within 8 hours; other low molecular weight heparins (LMWHs) or fondaparinux within 24 hours; any oral anti-Xa or antithrombin agent within 48 hours; or thrombolytics, glycoprotein inhibitors (GPI) or warfarin within 72 hours prior to the index procedure
  • Severe contrast allergy that cannot be pre-medicated
  • Procedures performed by radial access
  • 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, with the exception of ongoing participation in the EUCLID Trial which is permitted
  • Subjects who, for any reason, are deemed by the investigator to be inappropriate for this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913483

Contact: Tara G Richardson 9732906103 tara.richardson@themedco.com
Contact: Jenna Bisch 9732906171 jenna.bisch@themedco.com

United States, Arkansas
Tri-Lakes Research Recruiting
Hot Springs, Arkansas, United States, 71901
Contact: Cyndi Tauth    501-625-3400    CTheart0469@aol.com   
Principal Investigator: Jeffrey Tauth, MD         
United States, Florida
Clearwater Cardiovascular and Interventional Consultants Recruiting
Clearwater, Florida, United States, 33756
Contact: Michele Cameron    727-449-9257    CameronM@cccheart.com   
Principal Investigator: Douglas Spriggs, MD         
Florida Research Network Recruiting
Gainesville, Florida, United States, 32605
Contact: Kurt Malphurs, Pharmacist    352-333-0939    kurtm@flrnetwork.com   
Principal Investigator: Bret Wiechmann, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Manuel Perez, MD    407-539-2100    Manuel826@yahoo.com   
Principal Investigator: Manuel Perez, MD         
United States, Iowa
Midwest Cardiovascular Research Foundation Recruiting
Davenport, Iowa, United States, 52803
Contact: Holly Park    563-324-4384    parkh@mcrfmd.com   
Contact: Gail Shammas    563-324-4384    shammasg@mcrfmd.com   
Principal Investigator: Nicolas Shammas, MD         
United States, Michigan
Michigan Heart Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Autumn Howe, R.N.    734-712-8387      
Principal Investigator: Mansoor Qureshi, M.D.         
United States, New Jersey
Holy Name Medical Center Recruiting
Teaneck, New Jersey, United States, 07666
Contact: John Rundback, MD    201-833-7268    rundback@holyname.org   
Principal Investigator: John Rundback, MD         
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Esteban Henao, MD    505-841-1000    surgmax@hotmail.com   
Principal Investigator: Esteban Henao, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton, MS, RD, CCRC    212-342-1820    keb2114@columbia.edu   
Principal Investigator: William Gray, MD         
United States, North Carolina
Novant Health Heart and Vascular Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Lance E. Diehl, MD    704-264-1400    lediehl@novanthealth.org   
Principal Investigator: Lance E. Diehl, MD         
LeBauer Cardiovascular Research Foundation Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Muhammad Arida, MD    336-832-3799    muhammad.arida@conehealth.com   
Principal Investigator: Muhammad Arida, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Erica Seymour    216-444-0922    seymoue@ccf.org   
Principal Investigator: Daniel Clair, MD         
Jobst Vascular Institute Recruiting
Toledo, Ohio, United States, 43606
Contact: Christy Hansen, CCRC    419-291-2088    Christy.hansen@promedica.org   
Principal Investigator: Todd Russell, M.D.         
United States, South Carolina
AnMed Health Recruiting
Anderson, South Carolina, United States, 29621
Contact: Kathy Betsill, MS, RN, CNS    864-512-8734    kathy.betsill@anmedhealth.org   
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Tina Cooper, CCRP    843-792-1930    cooperti@musc.edu   
Principal Investigator: Claudio Schonholz, MD         
United States, Texas
Scott and White Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Margarite Grable, CCRP    254-724-5861    mgrable@sw.org   
Contact: Wanda Fikes, RN    254-724-5373    wfikes@sw.org   
Principal Investigator: Timothy Mixon, MD         
United States, Utah
Alpine Research Recruiting
Ogden, Utah, United States, 84403
Contact: Eric Mansell    801-791-2206    emansell@alpine-research.com   
Principal Investigator: Christopher Kim, MD         
United States, Virginia
INOVA Alexandria Hospital Recruiting
Alexandria, Virginia, United States, 22304
Contact: Arletta van Breda, RN, MSN    703-504-7760    arletta.vanbreda@inova.org   
Principal Investigator: Dimitrios Papadouris, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Stephen Lubatti    206-215-6573    Stephen.lubatti2@swedish.org   
Principal Investigator: Robert Bersin, MD         
Sponsors and Collaborators
The Medicines Company
  More Information

No publications provided

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT01913483     History of Changes
Other Study ID Numbers: MDCO-BIV-12-03
Study First Received: July 30, 2013
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014