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Length of Stay in NVAF Patients Hospitalized and Initiated With Dabigatran or Warfarin in Japan

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ClinicalTrials.gov Identifier: NCT02631057
Recruitment Status : Completed
First Posted : December 15, 2015
Results First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Atrial Fibrillation
Interventions Drug: Dabigatran
Drug: Warfarin
Enrollment 4313
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate [Prazaxa®] Warfarin
Hide Arm/Group Description The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
Period Title: Overall Study
Started 899 3414
Completed 899 3414
Not Completed 0 0
Arm/Group Title Dabigatran Etexilate [Prazaxa®] Warfarin Total
Hide Arm/Group Description The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF. Total of all reporting groups
Overall Number of Baseline Participants 899 3414 4313
Hide Baseline Analysis Population Description
The analysis set included patients who received the treatment Dabigatran Etexilate [Prazaxa®] or Warfarin.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 899 participants 3414 participants 4313 participants
70.2  (11.6) 76.1  (10.4) 74.9  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 899 participants 3414 participants 4313 participants
Female
297
  33.0%
1398
  40.9%
1695
  39.3%
Male
602
  67.0%
2016
  59.1%
2618
  60.7%
1.Primary Outcome
Title Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline
Hide Description The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.
Time Frame From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis set included patients who received the treatment Dabigatran Etexilate [Prazaxa®] or Warfarin.
Arm/Group Title Dabigatran Etexilate [Prazaxa®] Warfarin
Hide Arm/Group Description:
The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF).
Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
Overall Number of Participants Analyzed 899 3414
Mean (Standard Deviation)
Unit of Measure: Months
9.8  (13.5) 14.9  (19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dabigatran Etexilate [Prazaxa®], Warfarin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Abadie-Imbens
Comments LoS Average Treatment Effect on the Treated (ATET) [Dabigatran group], dispersion analysed with Abadie-Imbens’s standard error.
Method of Estimation Estimation Parameter Mean
Estimated Value -2.484
Confidence Interval (2-Sided) 95%
-3.717 to -1.251
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.629
Estimation Comments The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as [Dabigatran – Warfarin] in the matched cohort of matching ratio 1:3.
Time Frame Serious and other (non-serious) adverse events were not of interest in this study and therefore were not collected or assessed as part of the study, in addition individual patient data is not available therefore adverse event data is not presented.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate [Prazaxa®] Warfarin
Hide Arm/Group Description The patients were administered Dabigatran Etexilate 75 mg*2 mg capsules twice daily or 110 mg capsules twice daily orally for Non-Valvular Atrial Fibrillation (NVAF). Dose-adjusted Warfarin for several days to reach an effective International Normalized Ratio (INR) for ischemic stroke prevention due to NVAF.
All-Cause Mortality
Dabigatran Etexilate [Prazaxa®] Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate [Prazaxa®] 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 Etexilate [Prazaxa®] 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: 1800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02631057     History of Changes
Other Study ID Numbers: 1160.254
First Submitted: December 8, 2015
First Posted: December 15, 2015
Results First Submitted: August 30, 2017
Results First Posted: March 30, 2018
Last Update Posted: March 30, 2018