New York, United States
NCT Number: NCT02690155
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA
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
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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)
Exclusion criteria
- 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
Treatment and study plan
Rivaroxaban (Xarelto, BAY59-7939)
DrugAs prescribed by treating physicians
VKA (Vitamin K antagonist)
DrugAs prescribed by treating physicians
Primary outcomes
-
Incidence of Hospitalization Events (composite endpoint)
Time frame: Within 2 years of starting treatment
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Collaborators
- Janssen Research & Development, LLC
Registry information
Acronym: RIVA-F
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Feb 24, 2016
- Registry last updated
- Apr 5, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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