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Trial record 38 of 335 for:    DABIGATRAN

Comparative Effectiveness and Safety Between Warfarin and Dabigatran

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.
 
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

Brief Summary:
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Warfarin Drug: Dabigatran

Detailed Description:
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.

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Study Type : Observational
Actual Enrollment : 22490 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : October 30, 2017
Actual Study Completion Date : November 3, 2017


Group/Cohort Intervention/treatment
Atrial Fibrillation
patients with atrial fibrillation
Drug: Warfarin
patients treated with warfarin

Drug: Dabigatran
patients treated with Dabigatran
Other Name: PRADAXA




Primary Outcome Measures :
  1. 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. ]
    Incidence rate of stroke and systemic embolism (SE).


Secondary Outcome Measures :
  1. Incidence Rate of Major Bleeding [ 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. ]
    Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients with atrial fibrillation contained in the Medical Data Vision (MDVI) database which is a Japanese, nationwide claims data containing approximately 16 million patients cumulatively. The data cut is between March 2011 to June 2016, and the patients in the MDV database are those who have visited DPC hospitals (diagnostic procedure combination, a lump-sum payment system based on disease diagnosis to be treated similar to Medicare/Medicaid in the USA) hospitals which provide acute in-patient, as well as outpatient care.
Criteria

Inclusion Criteria:

  • patients aged >18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48)
  • having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016
  • having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)

Exclusion Criteria:

  • patients having less than 12 months of enrolment prior to the index date
  • being dialysis or kidney transplant recipients in baseline period
  • having either atrial flutter, valvular atrial fibrillation (AF)
  • mechanical valve placement, rheumatic AF
  • and/or mitral valve prolapse/regurge/stenosis in baseline period
  • having record of deep vein thrombosis or pulmonary embolism < 6 months before AF diagnosis in baseline period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254134


Locations
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Japan
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03254134     History of Changes
Other Study ID Numbers: 1160-0288
First Posted: August 18, 2017    Key Record Dates
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action