check_circleStudy Completed

Atrial Fibrillation

Bayer Identifier:

18734

ClinicalTrials.gov Identifier:

NCT02690155

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real-world comparative effectiveness of Rivaroxaban versus VKA

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • -NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient
    claims with ICD(International Classification of Disease)-9 427.31 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 score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65–74 years; Sc: Sex category)
  • -Patients <18 years of age
    -Patients with valvular AF (Atrial fibrillation)
    -Pregnancy
    -Malignant cancers
    -Transient cause of AF
    -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
     --Fatal bleeding
     --Fatal Stroke/Myocardial infarction
     --Intracranial hemorrhage
     --Ischemic stroke
     --Myocardial infarction

Trial summary

Enrollment Goal
38831
Trial Dates
February 2016 - March 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
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 Rivaroxaban 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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