Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial (ENDOMAX)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
The Medicines Company Identifier:
First received: July 30, 2013
Last updated: July 21, 2016
Last verified: July 2016
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    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 Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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 (excluding punch or shave skin 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 minutes (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 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
  • 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 identifier: NCT01913483

  Show 39 Study Locations
Sponsors and Collaborators
The Medicines Company
  More Information

Responsible Party: The Medicines Company Identifier: NCT01913483     History of Changes
Other Study ID Numbers: MDCO-BIV-12-03
Study First Received: July 30, 2013
Last Updated: July 21, 2016

Additional relevant MeSH terms:
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on April 28, 2017