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

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ClinicalTrials.gov Identifier: NCT00721136
Recruitment Status : Completed
First Posted : July 23, 2008
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.
Enrollment 104
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Moderate Risk Continuing Warfarin (Coumadin) Moderate Risk Holding Warfarin (Coumadin) High Risk Continuing Warfarin (Coumadin) High Risk Holding Warfarin (Coumadin)
Hide Arm/Group Description

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 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 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.

These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
Period Title: Overall Study
Started 42 42 8 8
Completed 42 42 8 8
Not Completed 0 0 0 0
Arm/Group Title Moderate Risk Continuing Warfarin Moderate Risk Holding Warfarin High Risk Continuing Warfarin High Risk Holding Warfarin Total
Hide Arm/Group Description

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 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 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.

These high risk patients randomized to holding coumadin for 4-5 days and using a heparin transition for bridging. Total of all reporting groups
Overall Number of Baseline Participants 42 42 8 8 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 8 participants 8 participants 100 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 8 participants 8 participants 100 participants
72.9  (11.4) 68.8  (11.7) 72.9  (11.4) 68.8  (11.7) 71.5  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 8 participants 8 participants 100 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 42 participants 8 participants 8 participants 100 participants
42 42 8 8 100
1.Primary Outcome
Title Bleeding Complication
Hide Description Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline characteristics of both groups were well matched except that patients randomized to warfarin discontinuation were more obese (P = .024).
Arm/Group Title Moderate Risk Continuing Warfarin Moderate Risk Holding Warfarin High Risk Continuing Warfarin High Risk Holding Warfarin
Hide Arm/Group Description:

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 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 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.

These high risk patients randomized to holding warfarin for 4-
Overall Number of Participants Analyzed 39 41 7 8
Measure Type: Number
Unit of Measure: participants
0 2 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moderate Risk Continuing Warfarin, Moderate Risk Holding Warfarin
Comments Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.
2.Primary Outcome
Title Thromboembolic Events
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moderate Risk Continuing Warfarin (Coumadin) Moderate Risk Holding Warfarin (Coumadin) High Risk Continuing Warfarin (Coumadin) High Risk Holding Warfarin (Coumadin)
Hide Arm/Group Description:

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 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 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.

These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
Overall Number of Participants Analyzed 39 41 7 8
Measure Type: Number
Unit of Measure: participants
0 1 0 0
3.Primary Outcome
Title Anticoagulant Related Complications
Hide Description Defined as warfarin induced skin necrosis or heparin-induced thrombocytopenia
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Moderate Risk Continuing Warfarin (Coumadin) Moderate Risk Holding Warfarin (Coumadin) High Risk Continuing Warfarin (Coumadin) High Risk Holding Warfarin (Coumadin)
Hide Arm/Group Description:

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 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 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.

These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.
Overall Number of Participants Analyzed 39 41 7 8
Measure Type: Number
Unit of Measure: participants
1 0 1 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moderate Risk Continuing Warfarin Moderate Risk Holding Warfarin High Risk Continuing Warfarin High Risk Holding Warfarin
Hide Arm/Group Description

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 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 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.

These high risk patients randomized to holding warfarin for 4-5 days and using a heparin transition for bridging.

All-Cause Mortality
Moderate Risk Continuing Warfarin Moderate Risk Holding Warfarin High Risk Continuing Warfarin High Risk Holding Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)      0/42 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Moderate Risk Continuing Warfarin Moderate Risk Holding Warfarin High Risk Continuing Warfarin High Risk Holding Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      1/42 (2.38%)      0/8 (0.00%)      0/8 (0.00%)    
Vascular disorders         
Transient Ischemic Attack  0/42 (0.00%)  0 1/42 (2.38%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Moderate Risk Continuing Warfarin Moderate Risk Holding Warfarin High Risk Continuing Warfarin High Risk Holding Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      1/42 (2.38%)      0/8 (0.00%)      2/8 (25.00%)    
Blood and lymphatic system disorders         
Pocket Hematoma  0/42 (0.00%)  0 0/42 (0.00%)  0 0/8 (0.00%)  0 2/8 (25.00%)  2
Pericardial Effusion  0/42 (0.00%)  0 1/42 (2.38%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
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.
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
Layout table for Results Point of Contact information
Name/Title: Charles Henrikson, MD
Organization: Johns Hopkins Medical Institutions
Phone: 503 494 7400
EMail: chenriks@jhmi.edu
Layout table for additonal information
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