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Anticoagulant Therapy During Pacemaker Implantation

NCT00479362 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2012-09-17

No results posted yet for this study

Summary

There are no established guidelines regarding interruption of warfarin anticoagulant therapy prior to surgical implantation of cardiac pacemakers. Continuing the anticoagulant could potentially result in increased bleeding complications from the implantation surgery, whereas discontinuing the anticoagulant could predispose the patient to blood clots and strokes. In this study we intend to randomly assign warfarin-treated patients either into interrupted or continued warfarin therapy prior to pacemaker implantation with the purpose of establishing the rate of complication in these groups. Our hypothesis is that a cardiac pacing device can be safely implanted without discontinuation of the anticoagulant therapy.

Conditions

Interventions

DRUG

Warfarin

Warfarin is either interrupted or uninterrupted prior to device implantation

DRUG

Aspirin

Aspirin is continued without interruption prior to device implantation

DEVICE

Permanent pacemaker

Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.

DEVICE

Implantable Cardioverter-defibrillator

Devices are implanted tailored each patient's clinical condition and need following local practices, national and international guidelines.

Sponsors & Collaborators

  • Satakunta Central Hospital

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • University of Turku

    lead OTHER

Principal Investigators

  • Juhani Airaksinen, MD · University of Turku, Turku University Hospital

  • Petri Korkeila, MD · Turku University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Finland

Study Locations

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Entities

Drugs
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 NCT00479362 on ClinicalTrials.gov