ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

The Medicines Company

Status and phase: Terminated; Phase 3

Conditions: Peripheral Endovascular Interventions; Bleeding

Treatments: Drug: Bivalirudin; Drug: Unfractionated Heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01913483

MDCO-BIV-12-03

Details and patient eligibility

About

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.

Enrollment: 732 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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732 participants in 2 patient groups

Bivalirudin

Experimental group

Description:

Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram \[kg\]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate \[eGFR\] \<30 milliliters/minute \[mL/min\]).

Treatment:

Drug: Bivalirudin

Unfractionated Heparin

Active Comparator group

Description:

UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.

Treatment:

Drug: Unfractionated Heparin