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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721136
First Posted: July 23, 2008
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: April 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Bradycardia
Tachycardia
Atrial Fibrillation
Valvular Heart Disease
Interventions: Drug: continue warfarin through the procedure
Drug: Hold warfarin
Drug: Warfarin held with heparin transition.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two patients from each treatment arm were excluded from the analysis. Three of these patients withdrew after being told of the treatment assignment, and one patient's procedure was cancelled owing to need for a left ventricular assist device.

Reporting Groups
  Description
Moderate Risk Continuing Warfarin (Coumadin)

Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.

These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.

Moderate Risk Holding Warfarin (Coumadin)

Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).

These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.

High Risk Continuing Warfarin (Coumadin)

High risk patients (mechanical mitral valve, prior stroke, current deep vein thrombosis, hypercoagulable syndrome) randomized to continue warfarin at the usual dose through the procedure.

These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.

High Risk Holding Warfarin (Coumadin) These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.

Participant Flow:   Overall Study
    Moderate Risk Continuing Warfarin (Coumadin)   Moderate Risk Holding Warfarin (Coumadin)   High Risk Continuing Warfarin (Coumadin)   High Risk Holding Warfarin (Coumadin)
STARTED   42   42   8   8 
COMPLETED   42   42   8   8 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Moderate Risk Continuing Warfarin

Moderate risk patients (afib, mechanical aortic valve) randomized to continue coumadin at their usual dose through the procedure.

These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.

Moderate Risk Holding Warfarin

Moderate risk patients randomized to hold their coumadin for 4-5 days prior to the procedure (to allow the INR to normalize).

These patients hold warfarin : For moderate risk patients, warfarin will be held for 4-5 days prior to the procedure.

High Risk Continuing Warfarin

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.

These patients continue warfarin through the procedure : The usual dose of warfarin (resulting in a therapeutic INR) is taken throughout the peri-procedural period.

High Risk Holding Warfarin These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging.
Total Total of all reporting groups

Baseline Measures
   Moderate Risk Continuing Warfarin   Moderate Risk Holding Warfarin   High Risk Continuing Warfarin   High Risk Holding Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   42   8   8   100 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      21  50.0%      21  50.0%      4  50.0%      4  50.0%      50  50.0% 
>=65 years      21  50.0%      21  50.0%      4  50.0%      4  50.0%      50  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.9  (11.4)   68.8  (11.7)   72.9  (11.4)   68.8  (11.7)   71.5  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      18  42.9%      20  47.6%      2  25.0%      2  25.0%      42  42.0% 
Male      24  57.1%      22  52.4%      6  75.0%      6  75.0%      58  58.0% 
Region of Enrollment 
[Units: Participants]
         
United States   42   42   8   8   100 


  Outcome Measures
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1.  Primary:   Bleeding Complication   [ Time Frame: 30 days ]

2.  Primary:   Thromboembolic Events   [ Time Frame: 30 days ]

3.  Primary:   Anticoagulant Related Complications   [ Time Frame: 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Evaluation period was limited to 4–6 weeks after implantation and mean INR levels in the warfarin continuation group did not reach levels above 2.5. This was a single center trial with experienced electrophysiologists using a common technique.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles Henrikson, MD
Organization: Johns Hopkins Medical Institutions
phone: 503 494 7400
e-mail: chenriks@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00721136     History of Changes
Other Study ID Numbers: NA_00011273
First Submitted: July 21, 2008
First Posted: July 23, 2008
Results First Submitted: April 3, 2013
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017