Real-world Comparative Effectiveness of Rivaroxaban Versus VKA
Launched by BAYER · Feb 19, 2016
Trial Information
Current as of May 15, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Bayer Study Director
Study Director
Bayer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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