ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

NCT ID: NCT01913483

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-24
• Study Completion Date: 2016-03-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bivalirudin

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 \[mL/min\]).

Group Type: EXPERIMENTAL

Bivalirudin

Intervention Type: DRUG

Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.

Unfractionated Heparin

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.

Group Type: ACTIVE_COMPARATOR

Unfractionated Heparin

Intervention Type: DRUG

Unfractionated heparin is an anticoagulant.

Interventions

Bivalirudin

Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.

Intervention Type: DRUG

Unfractionated Heparin

Unfractionated heparin is an anticoagulant.

Intervention Type: DRUG

Other Intervention Names

AngioMAX; Angiox; Heparin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Medicines Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tri-Lakes Research

Hot Springs, Arkansas, United States

Stanford Hospital and Clinics

Stanford, California, United States

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, United States

Florida Research Network

Gainesville, Florida, United States

The Cardiac and Vascular Institute

Gainesville, Florida, United States

Baptist Cardiac & Vascular Institute

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

Peoria Radiology Research & Education Foundation

Peoria, Illinois, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Kentucky Heart Foundation - King's Daughters Medical Center

Ashland, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

VA Boston Healthcare System

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Cape Cod Research Institute

Hyannis, Massachusetts, United States

Michigan Heart

Ypsilanti, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Weill Cornell Medical College

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Stony Brook Medicine

Stony Brook, New York, United States

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Jobst Vascular Institute

Toledo, Ohio, United States

Integris - Baptist Medical Center

Oklahoma City, Oklahoma, United States

Rhode Island Hospital

Providence, Rhode Island, United States

AnMed Health

Anderson, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Tech University Health Science Center

Lubbock, Texas, United States

Scott and White Hospital

Temple, Texas, United States

Alpine Research

Ogden, Utah, United States

INOVA Alexandria Hospital

Alexandria, Virginia, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

MDCO-BIV-12-03

Identifier Type: -

Identifier Source: org_study_id