REATTAIN: 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)
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
Drug: Apixaban
NOAC, reduced dose
Drug: Dabigatran
NOAC, reduced dose
|
| Vitamin K antagonists (VKA) Participants with NVAF initiating treatment with vitamin K antagonists (VKA) |
Drug: Warfarin
VKA
|
Outcome Measures
Primary Outcome Measures
- Number of participants with ischemic stroke (IS) or systemic embolism (SE) [Retrospective analysis from 2010 - 2018]
Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
- Number of participants with intracranial haemorrhage (ICH) [Retrospective analysis from 2010 - 2018]
Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
Other Outcome Measures
- Number of participants with severe IS [Retrospective analysis from 2010 - 2018]
Evaluation will be done in participants treated with reduced doses of individual NOACs
- Number of participants with fatal bleeding [Retrospective analysis from 2010 - 2018]
Evaluation will be done in participants treated with reduced doses of individual NOACs
- Number of participants with acute kidney injury (AKI) / kidney failure [Retrospective analysis from 2010 - 2018]
Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
- Time from initiation of treatment to discontinuation or switching of treatment [Retrospective analysis from 2010 - 2018]
Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
Eligibility Criteria
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
-
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
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Hip or knee replacement surgery in the 60 days prior to or on the index date
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A dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date
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A diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period or on the index date
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More than one dispensed OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date
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A dispensed prescription of an OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) during the baseline period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many locations | Multiple Locations | Sweden |
Sponsors and Collaborators
- Bayer
- Janssen, LP
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20030