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Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events

NCT01675076 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 663

Last updated 2019-10-07

No results posted yet for this study

Summary

The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

Conditions

  • Hematoma

Interventions

DRUG

Dabigatran

NOAC

DRUG

Rivaroxaban

NOAC

DRUG

Apixaban

NOAC

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • David Birnie, MD · Ottawa Heart Institute Research Corporation

  • Vidal Essebag, MD · McGill University

  • Jeff Healey, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-10-31
Completion
2018-05-31

Countries

  • Canada
  • Israel

Study Locations

More Related Trials

Entities

Companies

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 NCT01675076 on ClinicalTrials.gov