ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

This study is currently recruiting participants.
Verified September 2013 by The Medicines Company
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01913483
First received: July 30, 2013
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

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

  Eligibility

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

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

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

Locations
United States, Arkansas
Tri-Lakes Research Recruiting
Hot Springs, Arkansas, United States, 71901
Contact: Cyndi Tauth    501-625-3400    CTheart0469@aol.com   
United States, Florida
Clearwater Cardiovascular and Interventional Consultants Recruiting
Clearwater, Florida, United States, 33756
Contact: Michele Cameron    727-449-9257    CameronM@cccheart.com   
Florida Research Network Recruiting
Gainesville, Florida, United States, 32605
Contact: Kurt Malphurs, Pharmacist    352-333-0939    kurtm@flrnetwork.com   
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   
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   
LeBauer Cardiovascular Research Foundation Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Muhammad Arida, MD    336-832-3799    muhammad.arida@conehealth.com   
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   
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: March 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014