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Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) (REATTAIN)

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: NCT04249401
Recruitment Status : Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bayer

Brief Summary:
Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto [generic name rivaroxaban], Eliquis [generic name apixaban] or Pradaxa [generic name dabigatran]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism [effectiveness]) and intracranial hemorrhage a type of bleeding that occurs inside the skull [safety]).

Condition or disease Intervention/treatment
Atrial Fibrillation Drug: Rivaroxaban (Xarelto) Drug: Apixaban Drug: Dabigatran Drug: Warfarin

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Study Type : Observational
Estimated Enrollment : 70000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Reduced dose NOAC
Participants with NVAF initiating treatment with reduced doses of individual non-vitamin K antagonist oral anticoagulants (NOACs)
Drug: Rivaroxaban (Xarelto)
NOAC, reduced dose or standard dose

Drug: Apixaban
NOAC, reduced dose or standard dose

Drug: Dabigatran
NOAC, reduced dose or standard dose

Standard dose NOAC
Participants with NVAF initiating treatment with standard doses of individual NOACs
Drug: Rivaroxaban (Xarelto)
NOAC, reduced dose or standard dose

Drug: Apixaban
NOAC, reduced dose or standard dose

Drug: Dabigatran
NOAC, reduced dose or standard dose

Vitamin K antagonists (VKA)
Participants with NVAF initiating treatment with vitamin K antagonists (VKA)
Drug: Warfarin
VKA




Primary Outcome Measures :
  1. Number of participants with ischemic stroke (IS) or systemic embolism (SE) [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA

  2. Number of participants with intracranial haemorrhage (ICH) [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA


Secondary Outcome Measures :
  1. Number of participants with IS/SE [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with standard doses of individual NOACs

  2. Number of participants with ICH [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with standard doses of individual NOACs

  3. Number of participants with severe IS [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with standard doses of individual NOACs

  4. Number of participants with fatal bleeding [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with standard doses of individual NOACs

  5. Number of participants with acute kidney injury (AKI) / kidney failure [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA

  6. Time from initiation of treatment to discontinuation or switching of treatment [ Time Frame: Retrospective analysis from 2010 - 2018 ]
    Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA



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
Patients with NVAF who initiate treatment with oral anticoagulants (OACs, either VKAs or NOACs)
Criteria

Inclusion Criteria:

  • Patients with a qualifying oral OAC dispensed during the study period
  • A primary diagnosis indicative of atrial fibrillation during the baseline period

Exclusion Criteria:

  • Age < 18 years at index date
  • A diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period
  • Hip or knee replacement surgery in the 60 days prior to or on the index date
  • A dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date
  • A diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period
  • More than one dispensed OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date
  • A dispensed prescription of an OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) before the 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): NCT04249401


Locations
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Sweden
Many locations
Multiple Locations, Sweden
Sponsors and Collaborators
Bayer
Janssen, LP
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04249401    
Other Study ID Numbers: 20030
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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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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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Warfarin
Rivaroxaban
Dabigatran
Apixaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action