NCT01913483

ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: The Medicines Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Endovascular Interventions
• Bleeding

Interventions

Type	Name	Description
DRUG	Bivalirudin	Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.
DRUG	Unfractionated Heparin	Unfractionated heparin is an anticoagulant.

Timeline

• Start date: 2013-09-24
• Primary completion: 2016-03-16
• Completion: 2016-03-16
• First posted: 2013-08-01
• Last updated: 2017-05-30
• Results posted: 2017-05-30

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study