Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon (ReLoaDeD)

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: NCT03563937
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : November 27, 2020
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting.

The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.


Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Phenprocoumon Drug: Apixaban Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Edoxaban

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 64920 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Phenprocoumon
Patients with NVAF who initiated the treatment of Phenprocoumon.
 Drug: Phenprocoumon
Follow the physician's prescription.
Apixaban
Patients with NVAF who initiated the treatment of Apixaban.
 Drug: Apixaban
2.5 mg or 5 mg, twice daily
Rivaroxaban (Xarelto, BAY59-7939)
Patients with NVAF who initiated the treatment of Rivaroxaban.
 Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg or 20 mg, once daily
Edoxaban
Patients with NVAF who initiated the treatment of Edoxaban.
 Drug: Edoxaban
30 mg or 60 mg, once daily


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Risk of Ischemic stroke (IS) / Systemic embolism(SE) (as combined endpoint and alone), recurrent IS/SE (as combined endpoint) and severe IS in patients with NVAF and renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
    Severe IS will be defined according to an approach proposed by Schubert et al. as hospitalization with a primary hospital discharge diagnosis of IS in combination with an OPS (Operationen und Prozedurenschlüssel) code indicating one of the following: intubation, mechanical ventilation or percutaneous endoscopic gastronomy

  2. Risk of intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) with renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  3. Healthcare resource consumption in patients with non-valvular atrial fibrillation (NVAF) and renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  4. Overall costs in patients with renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  5. Sector specific costs in patients with renal impairment determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Secondary Outcome Measures :
  1. Risk of fatal bleeding in patients with NVAF (overall population as well as patients with renal impairment) determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
    Fatal bleeding will be defined as hospitalization with a primary hospital discharge diagnoses for bleeding with documented death as reason for hospital discharge or within 30 days after hospital discharge.

  2. Risk of recurrent hospitalizations (in general and for IS/SE) [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  3. Risk of Kidney failure determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  4. Risk of Acute kidney injury (AKI) determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  5. Risk of treatment discontinuation in patients with NVAF (overall population as well as patients with renal impairment) determined by pharmacy claims [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]
  6. Risk of IS, SE, Severe IS and recurrent IS/SE in patient with NVAF determined determined by inpatient claims based diagnoses [ Time Frame: Retrospective analysis from January 2012 - December 2017 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 include all insured members of approximately 64 German statutory health insurances (SHIs) contributing data to the InGef database.
Criteria

Inclusion Criteria:

  • First NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st January 2013 to 30th June 2017 (index date).
  • Age of at least 18 years at index date.
  • Continuous enrollment in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).
  • A verified ambulatory or primary/ secondary hospital discharge diagnosis of NVAF in the 12 months before the first NOAC (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period).

Exclusion Criteria:

  • A verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (VTE).
  • A claim for hip or knee replacement surgery in the 60 days prior to or on the index date.
  • A prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date.
  • A prescription of warfarin or dabigatran in the baseline period or on the index date.
  • A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period.
  • Patients receiving an initial dose of rivaroxaban 10 mg/ 2.5 mg or edoxaban 15 mg (these dosages are not indicated for the treatment of NVAF).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03563937


Locations
Layout table for location information
Germany
Many Locations
Multiple Locations, Germany
Sponsors and Collaborators
Bayer
Janssen Research & Development, LLC
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03563937    
Other Study ID Numbers: 20031
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Apixaban
Edoxaban
 Phenprocoumon
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants