Trial Condition(s):
Nonvalvular Atrial Fibrillation
Rivaroxaban vs warfarin for SPAF in multi-morbid patients
Bayer Identifier:
19859
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice.
The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
Inclusion Criteria
- Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and - Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study’s baseline period)
Exclusion Criteria
- <18 years of age - <2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation - Valvular heart disease - Transient cause of NVAF - Venous thromboembolism - Hip or knee arthroplasty - Malignant cancer - Pregnancy - >1 oral anticoagulant prescribed (on index date)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases Many locations, United States, 20001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Comparative effectiveness of rivaroxaban and warfarin for stroke prevention in multi-morbid patients with nonvalvular atrial fibrillation
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Stroke or systemic embolism (SSE)Timeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
- Major bleedingWithout access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithmTimeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
Secondary Outcome
- Hemorrhagic strokeTimeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
- Ischemic strokeTimeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
- Subtypes of major bleedingTimeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
- Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)Timeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
- Acute kidney injuryTimeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
- Renal impairmentTimeframe: Retrospective analysis from January 1, 2011 to December 31, 2017
Additional Information
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