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)

NCT04249401 | Completed

• 1 other identifier: 20030
• Study Type: observational
• Target: 134,897
• Locations: 1 country
• Sites: 1

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 \[safety\]).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of participants with ischemic stroke (IS) or systemic embolism (SE)

  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)

  Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA

  Retrospective analysis from 2010 - 2018

Study Arms (2)

Reduced dose NOAC

Participants with NVAF initiating treatment with reduced doses of individual non-vitamin K antagonist oral anticoagulants (NOACs)

Drug: Rivaroxaban (Xarelto); Drug: Apixaban; Drug: Dabigatran

Vitamin K antagonists (VKA)

Participants with NVAF initiating treatment with vitamin K antagonists (VKA)

Drug: Warfarin

Interventions

Rivaroxaban (Xarelto) DRUG

NOAC, reduced dose

Reduced dose NOAC

Apixaban DRUG

NOAC, reduced dose

Reduced dose NOAC

Dabigatran DRUG

NOAC, reduced dose

Reduced dose NOAC

Warfarin DRUG

VKA

Vitamin K antagonists (VKA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Many locations

Multiple Locations, Sweden

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; apixaban; Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 31, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)