ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Bivalirudin vs Unfractionated Heparin; p = 0.9458; Chi-squared NCT01913483 ↗

Drugs

Indications