Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

NCT ID: NCT02687867

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56039 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-12
• Study Completion Date: 2016-03-01

Brief Summary

To obtain a better understanding on the comparative effectiveness of dabigatran versus Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial fibrillation (NVAF) in a real-life setting.

Conditions

Atrial Fibrillation

Study Design

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

Study Groups

Dabigatran

Non-valvular atrial fibrillation patients who were initiated on dabigatran for stroke prevention.

Dabigatran (Pradaxa)

Intervention Type: DRUG

As prescribed by treating physicians

Vitamin K antagonist

Non-valvular atrial fibrillation patients who were initiated on VKA for stroke prevention.

Vitamin K antagonist

Intervention Type: DRUG

As prescribed by treating physicians

Interventions

Dabigatran (Pradaxa)

As prescribed by treating physicians

Intervention Type: DRUG

Vitamin K antagonist

As prescribed by treating physicians

Intervention Type: DRUG

Other Intervention Names

As prescribed by treating physicians

Eligibility Criteria

Inclusion Criteria

• Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) as the diagnosis code at any time in the patient's data history prior to inclusion
• Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
• CHA2DS2-Vasc (Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category ) score ≥2 during the 180 days prior to index dabigatran use baseline period

Exclusion Criteria

• Patients <18 years of age
• Patients with valvular Atrial fibrillation
• Pregnancy
• Malignant cancers
• Transient cause of Atrial fibrillation
• Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)
• Patients with major surgery defined as hip or knee replacement
• Prescriptions of Oral anticoagulants (OACs) {apixaban, warfarin, dabigatran, rivaroxaban} before index date
• Prescription of more than one OAC on the index date
• Patient with any of the events defined in the composite endpoint

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

New York, New York, United States

Countries

United States

Other Identifiers

NN1513US

Identifier Type: OTHER

Identifier Source: secondary_id

18732

Identifier Type: -

Identifier Source: org_study_id