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NCT Number: NCT04249401

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)

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]).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (Xarelto)

Drug

NOAC, reduced dose

Apixaban

Drug

NOAC, reduced dose

dabigatran

Drug

NOAC, reduced dose

Warfarin

Drug

VKA

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Johnson & Johnson

Registry information

Official study title

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

Acronym: REATTAIN

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 31, 2020
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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