The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis

NCT ID: NCT03026556

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42534 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-29
• Study Completion Date: 2017-08-23

Brief Summary

The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly initiated apixaban users

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dabigatran vs. Rivaroxaban

OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, rivaroxaban (new oral anticoagulant or NOAC).

Dabigatran vs. Rivaroxaban

Intervention Type: DRUG

observed for 6 years

Dabigatran vs. Apixaban

OAC treatment naïve NVAF patients with at least one prescription claim for dabigatran, or apixaban (new oral anticoagulant or NOAC).

Dabigatran vs. Apixaban

Intervention Type: DRUG

Observed for 6 years

Interventions

Dabigatran vs. Rivaroxaban

observed for 6 years

Intervention Type: DRUG

Dabigatran vs. Apixaban

Observed for 6 years

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18+ on index date
• Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date;
• Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period.
• Patients must have at least 12 months of continuous eligibility prior to the index date;
• Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period.

Exclusion Criteria

Less than 12 months of continuous eligibility in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period

Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to exclude patients with "transient" causes of Afib (3 months prior to index date in pre-period):

• Cardiac surgery
• Pericarditis
• Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to exclude patients with "valvular" Afib (pre-period):
• Mitral stenosis
• Mitral stenosis with insufficiency
• Mitral valve stenosis and aortic valve stenosis
• Mitral valve stenosis and aortic valve insufficiency
• Diseases of other endocardial structures
• Other and unspecified rheumatic heart diseases
• Open heart valvuloplasty without replacement
• Open and other replacement of unspecified heart valve
• Open and other replacement of aortic valve
• Open and other replacement of mitral valve
• Open and other replacement of pulmonary valve
• Open and other replacement of tricuspid valve
• Heart valve replaced by transplant
• Heart valve replaced by a mechanical device/prosthesis
• Atrioventricular valve repair
• Aortic valve valvuloplasty
• Unlisted procedure, cardiac surgery
• Implantation of catheter-delivered prosthetic aortic heart valve; open thoracic approach
• Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; without cardiopulmonary bypass
• Transthoracic cardiac exposure (e.g., sternotomy, thoracotomy, subxiphoid) for catheter-delivered aortic valve replacement; with cardiopulmonary bypass
• Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve
• Valvuloplasty, mitral valve, with cardiopulmonary bypass
• Valvuloplasty, mitral valve, with cardiopulmonary bypass; with prosthetic ring
• Valvuloplasty, mitral valve, with cardiopulmonary bypass; radical reconstruction, with or without ring
• Replacement, mitral valve, with cardiopulmonary bypass
• Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach
• Replacement, pulmonary valve
• Valvectomy, tricuspid valve, with cardiopulmonary bypass
• Valvuloplasty, tricuspid valve; without ring insertion
• Valvuloplasty, tricuspid valve; with ring insertion
• Replacement, tricuspid valve, with cardiopulmonary bypass

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health ResearchTx, LLC (HRTX)

UNKNOWN

Sponsor Role: collaborator

inVentiv Health Clinical (iVH)

UNKNOWN

Sponsor Role: collaborator

United States Department of Defense (DOD)

UNKNOWN

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inventiv Health

Princeton, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1160-0274

Identifier Type: -

Identifier Source: org_study_id