Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charles Henrikson, MD - Cardiology/Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00721136
First received: July 21, 2008
Last updated: October 2, 2012
Last verified: October 2012

July 21, 2008
October 2, 2012
September 2007
August 2010   (final data collection date for primary outcome measure)
bleeding complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00721136 on ClinicalTrials.gov Archive Site
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Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation
Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation

Patients requiring long term anticoagulation often undergo transition of their warfarin to heparin in anticipation of invasive surgical procedures such as pacemaker or ICD implantation. This may require inpatient hospitalization several days prior to and after the procedure, potentially increasing medical costs and patient inconvenience. Patients undergoing such a process are initiated on heparin while their INRs drift to normal levels. Immediately prior to surgery, heparin is discontinued and restarted several hours after the procedure. Unfortunately, this process has resulted in a high incidence of surgical wound hematomas and other bleeding complications often requiring longer periods of discontinued anticoagulation or repeat surgical exploration. Previous investigators have tried to reduce the incidence of wound hematomas by prolonging the time from surgical wound closure to the reinitiation of heparin. A small randomized trial demonstrated that there was no significant difference in the incidence of wound hematomas whether heparin was started 6 hours or 24 hours after surgery (J Am Coll Cardiology 2000;35:1915-8). This has led many investigators to perform pacemaker and ICD implantation without reversal of warfarin therapy. A recent retrospective observational study demonstrated that the incidence of wound hematomas in patients with an INR of 2.6 was no different than patients with an INR of 1.5 (PACE 2004;27:358-60). Furthermore, a more recent, larger retrospective observational study reported in abstract form at the recent Heart Rhythm Society Annual 2007 Scientific Meeting demonstrated that not only is performing pacemaker and ICD implantations safe without reversing warfarin anticoagulation, but the incidence of wound hematomas is significantly smaller as compared to the strategy of reversing warfarin and initiating periprocedural heparin.

Given these findings, the hypothesis of this randomized study is that pacemaker and ICD implantation while fully anticoagulated on warfarin therapy is safe. Findings from this study will have significant implications on the clinical practice of pacemaker or ICD implantation in this patient population given that no randomized study on this subject has been performed to date.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Bradycardia
  • Tachycardia
  • Atrial Fibrillation
  • Valvular Heart Disease
  • Drug: continue warfarin through the procedure
    The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.
  • Drug: Hold warfarin
    For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.
  • Drug: Warfarin held with heparin transition.
    For high risk patients, warfarin is held for 4-5 days prior to the procedure and heparin is given to provide anticoagulation while the INR is subtherapeutic.
  • Experimental: 1
    Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.
    Intervention: Drug: continue warfarin through the procedure
  • Active Comparator: 2
    Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).
    Intervention: Drug: Hold warfarin
  • Experimental: 3
    High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue coumadin at the usual dose through the procedure.
    Intervention: Drug: continue warfarin through the procedure
  • Active Comparator: 4
    High risk patients randomized to holding coumadin for 4-5 days and using "bridging" anticoagulation with heparin while the coumadin is held.
    Intervention: Drug: Warfarin held with heparin transition.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • scheduled for clinically indicated permanent pacemaker or implantable cardioverter-defibrillator
  • currently on chronic warfarin therapy

Exclusion Criteria:

  • unwilling to participate in trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721136
NA_00011273
No
Charles Henrikson, MD - Cardiology/Medicine, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Alan Cheng, MD Johns Hopkins University
Johns Hopkins University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP