drugset / Trial / NCT01913483
ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |