Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Comparative Effectiveness and Safety Between Warfarin and Dabigatran Using Real World Claims Data of Japanese Non-valvular Atrial Fibrillation Patients

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 22490

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Nippon Boehringer Ingelheim Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atrial Fibrillation; patients with atrial fibrillation	Drug: Warfarin; patients treated with warfarin; Drug: Dabigatran; patients treated with Dabigatran; Other Names: PRADAXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Stroke and Systemic Embolism (SE)	Incidence rate of stroke and systemic embolism (SE).	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Major Bleeding	Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.	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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): November 3, 2017

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Warfarin
• Other Study ID Numbers: 1160-0288

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No