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