Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03374540
• Collaborator: Janssen Research & Development, LLC (Industry)
• Enrollment: 78,517
• Location: 1
• Actual Duration (Months): 20.9
• Patients Per Site Per Month: 3751.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nonvalvular Atrial Fibrillation	Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Vitamin K antagonist (VKA)

Study Design

• Study Type: Observational
• Actual Enrollment: 78517 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Aug 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Rivaroxaban Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban	Drug: Rivaroxaban (Xarelto, BAY59-7939); 15/20 mg
Vitamin K antagonist (VKA) Patients who initiated OAC treatment with VKA	Drug: Vitamin K antagonist (VKA); Individually adjusted dose

Outcome Measures

Primary Outcome Measures

1. Stroke or systemic embolism (SSE) [Retrospective analysis from January 1, 2011 to December 31, 2017]

2. Major bleeding [Retrospective analysis from January 1, 2011 to December 31, 2017]

   Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm

Secondary Outcome Measures

1. Hemorrhagic stroke [Retrospective analysis from January 1, 2011 to December 31, 2017]

2. Ischemic stroke [Retrospective analysis from January 1, 2011 to December 31, 2017]

3. Subtypes of major bleeding [Retrospective analysis from January 1, 2011 to December 31, 2017]

4. Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs) [Retrospective analysis from January 1, 2011 to December 31, 2017]

5. Acute kidney injury [Retrospective analysis from January 1, 2011 to December 31, 2017]

6. Renal impairment [Retrospective analysis from January 1, 2011 to December 31, 2017]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases	Multiple Locations	Washington	United States	20001

Sponsors and Collaborators

• Bayer
• Janssen Research & Development, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find results for studies related to Bayer products

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03374540
• Other Study ID Numbers: 19859
• First Posted: Dec 15, 2017
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Vitamin K; Rivaroxaban

Study Results

No Results Posted as of Aug 17, 2020