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ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial

NCT01913483 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2017-05-30

Study results available
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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

Interventions

DRUG

Bivalirudin

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

DRUG

Unfractionated Heparin

Unfractionated heparin is an anticoagulant.

Sponsors & Collaborators

  • The Medicines Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-24
Primary Completion
2016-03-16
Completion
2016-03-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913483 on ClinicalTrials.gov