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Trial record 38 of 333 for:    DABIGATRAN

Comparative Effectiveness and Safety Between Warfarin and Dabigatran

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ClinicalTrials.gov Identifier: NCT03254134
Recruitment Status : Completed
First Posted : August 18, 2017
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Atrial Fibrillation
Interventions Drug: Warfarin
Drug: Dabigatran
Enrollment 22490
Recruitment Details A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.
Pre-assignment Details The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) and newly treated with dabigatran and warfarin in the real world Japanese setting between April 2010 and June 2016 using the Medical Data Vision (MDV) database.
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Period Title: Overall Study
Started 5745 16745
Completed 5146 13115
Not Completed 599 3630
Reason Not Completed
Not eligible patients             599             3630
Arm/Group Title Dabigatran Warfarin Total
Hide Arm/Group Description Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. Total of all reporting groups
Overall Number of Baseline Participants 5146 13115 18261
Hide Baseline Analysis Population Description
Eligible patients who were prescribed dabigatran and warfarin as the first OACs
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5146 participants 13115 participants 18261 participants
72  (10) 78  (10) 76  (10)
[1]
Measure Analysis Population Description: Eligible patients who were prescribed dabigatran and warfarin as the first OACs
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5146 participants 13115 participants 18261 participants
Female
1695
  32.9%
5294
  40.4%
6989
  38.3%
Male
3451
  67.1%
7821
  59.6%
11272
  61.7%
[1]
Measure Analysis Population Description: Eligible patients who were prescribed dabigatran and warfarin as the first OACs
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Incidence Rate of Stroke and Systemic Embolism (SE)
Hide Description Incidence rate of stroke and systemic embolism (SE).
Time Frame From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Overall Number of Participants Analyzed 4606 4606
Measure Type: Number
Unit of Measure: per patient-year
2.898 3.563
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments There was no formal hypothesis testing.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.720
Confidence Interval (2-Sided) 95%
0.534 to 0.970
Estimation Comments [Not Specified]
Other Statistical Analysis The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable
2.Secondary Outcome
Title Incidence Rate of Major Bleeding
Hide Description Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
Time Frame From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description:
Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Overall Number of Participants Analyzed 4606 4606
Measure Type: Number
Unit of Measure: per patient-year
0.639 1.128
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran, Warfarin
Comments There was no formal hypothesis testing.
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.549
Confidence Interval (2-Sided) 95%
0.303 to 0.994
Estimation Comments [Not Specified]
Other Statistical Analysis The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable
Time Frame [Not Specified]
Adverse Event Reporting Description This is a cohort study using based on existing data; therefore, it is not feasible to make a causality assessment at the individual case level.
 
Arm/Group Title Dabigatran Warfarin
Hide Arm/Group Description Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
All-Cause Mortality
Dabigatran Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03254134     History of Changes
Other Study ID Numbers: 1160-0288
First Submitted: August 17, 2017
First Posted: August 18, 2017
Results First Submitted: October 30, 2018
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019