check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18732

ClinicalTrials.gov Identifier:

NCT02687867

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real-world comparative effectiveness of Dabigatran versus Vitamin K antagonist

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - 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

Trial summary

Enrollment Goal
56039
Trial Dates
February 2016 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
New York, United States

Primary Outcome

  • Incidence of Hospitalization Events (composite endpoint)
    date_rangeTime Frame:
    Within 2 years of starting treatment
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Real-world comparative effectiveness of Dabigatran versus VKA
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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