Study 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

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

Trial summary

Enrollment Goal

56039

Trial Dates

February 2016 - March 2016

Phase

N/A

Could I Receive a placebo

Products

No Drug

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		New York, United States

Primary Outcome

Incidence of Hospitalization Events (composite endpoint)
Time Frame:
Within 2 years of starting treatment
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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