Comparative Effectiveness and Safety Between Warfarin and Dabigatran

NCT03254134 | Completed Results FDA Drug

• 1 other identifier: 1160-0288
• Study Type: observational
• Target: 22,490
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence Rate of Major Bleeding

  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.

Study Arms (1)

Atrial Fibrillation

patients with atrial fibrillation

Drug: Warfarin; Drug: Dabigatran

Interventions

Warfarin DRUG

patients treated with warfarin

Atrial Fibrillation

Dabigatran DRUG

patients treated with Dabigatran

Also known as: PRADAXA

Atrial Fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin; Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 18, 2017
• Study Start: October 20, 2017
• Primary Completion: October 30, 2017
• Study Completion: November 3, 2017
• Last Updated: July 9, 2019
• Results First Posted: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)