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Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374540
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The overall goal of this study is 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 is 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
Nonvalvular Atrial Fibrillation Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Vitamin K antagonist(VKA)

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Study Type : Observational
Actual Enrollment : 99999 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 : December 1, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Stroke [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  2. Systemic embolism [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  3. Major bleeding [ Time Frame: 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 [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  2. Ischemic stroke [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  3. Subtypes of major bleeding [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  4. Adverse cardiovascular and limb events [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  5. Acute kidney injury [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]
  6. Renal impairment [ Time Frame: Retrospective analysis from January 1, 2011 to December 31, 2017 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The source population of this study will be all the insured individuals included in the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases (Truven MarketScan).
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374540


Locations
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United States, Washington
Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
Multiple Locations, Washington, United States, 20001
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03374540    
Other Study ID Numbers: 19859
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamins
Vitamin K
Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants