Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Vitamin K antagonist; Drug: Dabigatran (Pradaxa)

• Registration Number: NCT02687867
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-12
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-22
• Primary Completion: 2016-03-01
• Study Completion: 2016-03-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56039

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamin K antagonist	Vitamin K antagonist	Non-valvular atrial fibrillation patients who were initiated on VKA for stroke prevention.
Dabigatran	Dabigatran (Pradaxa)	Non-valvular atrial fibrillation patients who were initiated on dabigatran for stroke prevention.

Primary Outcome Measures

Name	Time	Method
Incidence of Hospitalization Events (composite endpoint)	Within 2 years of starting treatment