ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

• Status: Terminated
• Trial end date: 2016-03-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medicines Company
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

Criteria

Inclusion Criteria:

• Participants ≥ 18 years of age

• Must be undergoing one of the following PEI procedures:

• Carotid artery stenting

• Lower Extremity Interventions (LEI) for Critical Limb Ischemia

• LEI for claudication

• Provide written informed consent prior to any study-specific procedure being performed

Exclusion Criteria:

• Any known contra-indication to the use of bivalirudin or UFH

• Acute limb ischemia

• Planned amputation regardless of the outcome of the PEI

• Dialysis dependent

• Weight less than 38 kg or more than 202 kg

• History of any bleeding diathesis or severe hematological disease

• History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage

• Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization

• Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization

• Concomitant percutaneous coronary intervention

• Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization

• International normalized ratio >1.7 within 24 h prior to the index procedure

• Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to the intervention)

• Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure

• Severe contrast allergy that cannot be pre-medicated

• Procedures performed by radial access when they are intended as the primary access site for the index procedure

• Known or suspected pregnant women or nursing mothers

• Previous enrollment in this study (MDCO-BIV-12-03)

• Participation in other investigational drug or device trials within 30 days prior to randomization

• Participants who, for any reason, are deemed by the investigator to be inappropriate for this study