drugset / Trial / NCT01913483

ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

NCT01913483

Phase 3 Terminated 732 enrolled The Medicines Company
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the study is to test whether anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in participants undergoing peripheral endovascular interventions (PEI). The secondary objective is to test whether there were 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.

Timeline

Start
2013-09-24
Primary completion
2016-03-16
Completion
2016-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Bivalirudin Peptide 1 mg/kg Intravenous
Subject Bivalirudin Peptide 1.75 mg/kg Intravenous
Comparator Heparin Other / unclassified 50 iu/kg Intravenous
Comparator Heparin Other / unclassified 70 iu/kg Intravenous