Clinical trial NCT01913483: ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Official title: ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Peripheral Endovascular Interventions
Bleeding
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2013-08-01
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
timeFrame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
Secondary outcomes:
measure: Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration
timeFrame: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
measure: Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
timeFrame: Study drug initiation (Day 1) up to 30 days
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Tri-Lakes Research
state: Arkansas
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Clearwater
country: United States
facility: Clearwater Cardiovascular and Interventional Consultants
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Miami
country: United States
facility: Baptist Cardiac & Vascular Institute
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Peoria
country: United States
facility: Peoria Radiology Research & Education Foundation
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Ashland
country: United States
facility: Kentucky Heart Foundation - King's Daughters Medical Center
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hyannis
country: United States
facility: Cape Cod Research Institute
state: Massachusetts
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Institute
state: North Carolina
city: Greensboro
country: United States
facility: LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: Jobst Vascular Institute
state: Ohio
city: Oklahoma City
country: United States
facility: Integris - Baptist Medical Center
state: Oklahoma
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Lubbock
country: United States
facility: Texas Tech University Health Science Center
state: Texas
city: Temple
country: United States
facility: Scott and White Hospital
state: Texas
city: Ogden
country: United States
facility: Alpine Research
state: Utah
city: Alexandria
country: United States
facility: INOVA Alexandria Hospital
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: