Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist

NCT02687867 | Completed

• 2 other identifiers: 18732NN1513US
• Study Type: observational
• Target: 56,039
• Locations: 1 country
• Sites: 1

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

Keywords

Non-valvular atrial fibrillation (NVAF); Prevention; Stroke

Outcome Measures

Primary Outcomes (1)

• Incidence of Hospitalization Events (composite endpoint)

  Within 2 years of starting treatment

Study Arms (2)

Dabigatran

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

Drug: Dabigatran (Pradaxa)

Vitamin K antagonist

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

Drug: Vitamin K antagonist

Interventions

Dabigatran (Pradaxa) DRUG

As prescribed by treating physicians

Dabigatran

Vitamin K antagonist DRUG

As prescribed by treating physicians

Also known as: As prescribed by treating physicians

Vitamin K antagonist

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

Patients with non-valvular atrial fibrillation (NVAF).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

New York, New York, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Dabigatran; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 22, 2016
• Study Start: February 12, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (1)