This trial is active, not recruiting.

Condition peripheral endovascular interventions
Treatment bivalirudin
Phase phase 3
Sponsor The Medicines Company
Start date September 2013
End date December 2016
Trial size 3900 participants
Trial identifier NCT01913483, MDCO-BIV-12-03


The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Bivalirudin will be administered as a bolus and infusion. The bolus (0.75 mg/kg) will be administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin will be initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for subjects with an eGFR <30 mL/min).
(Active Comparator)
UFH will be administered as an initial weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses may be administered per the pre-defined heparin dosing algorithm.

Primary Outcomes

time frame: 48 hrs

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subjects ≥ 18 years of age - Must be undergoing one of the following PEI procedures: - Carotid artery stenting (approximately 33% of study sample) - Lower Extremity Interventions (LEI) for Critical Limb Ischemia (CLI) (approximately 33% of study sample) - LEI for claudication (approximately 33% of study sample) - 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 kilograms (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 (PCI) - Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization - International normalized ratio (INR) >1.7 within 24 hours (h) prior to the index procedure - Administration of therapeutic doses of UFH within 30 minutes (min) prior to the index procedure (a low dose [≤2000 units (U)] of heparin is permitted during the diagnostic angiogram prior to the intervention) - Administration of enoxaparin within 8 hours; other low molecular weight heparins (LMWHs) or fondaparinux within 24 hours; any oral anti-Xa or antithrombin agent within 48 hours; or thrombolytics, glycoprotein inhibitors (GPI), or warfarin within 72 hours 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 - Subjects who, for any reason, are deemed by the investigator to be inappropriate for this study

Additional Information

Official title ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by The Medicines Company.