ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Medicines Company
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01913483
First received: July 30, 2013
Last updated: October 8, 2014
Last verified: July 2014

July 30, 2013
October 8, 2014
September 2013
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01913483 on ClinicalTrials.gov Archive Site
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ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Endovascular Interventions
Drug: Bivalirudin
  • 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).
    Intervention: 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.
    Intervention: Drug: Bivalirudin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3900
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Tara G Richardson 9732906103 tara.richardson@themedco.com
Contact: Jenna Bisch 9732906171 jenna.bisch@themedco.com
United States
 
NCT01913483
MDCO-BIV-12-03
Not Provided
The Medicines Company
The Medicines Company
Not Provided
Not Provided
The Medicines Company
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP