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)

October 24, 2023 updated by: Bayer

Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics

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]).

Study Overview

Study Type

Observational

Enrollment (Actual)

134897

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Multiple Locations, Sweden
        • Many Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

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
  • Died on index date
  • A diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period or on the index date
  • 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 or on the index date
  • 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) during the baseline period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Reduced dose NOAC
Participants with NVAF initiating treatment with reduced doses of individual non-vitamin K antagonist oral anticoagulants (NOACs)
NOAC, reduced dose
NOAC, reduced dose
NOAC, reduced dose
Vitamin K antagonists (VKA)
Participants with NVAF initiating treatment with vitamin K antagonists (VKA)
VKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Retrospective analysis from 2010 - 2018
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
Retrospective analysis from 2010 - 2018

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Retrospective analysis from 2010 - 2018
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
Retrospective analysis from 2010 - 2018
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
Retrospective analysis from 2010 - 2018
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
Retrospective analysis from 2010 - 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later 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.vivli.org 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 member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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