- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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) (REATTAIN)
Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Multiple Locations, Sweden
- Many Locations
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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)
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NOAC, reduced dose
NOAC, reduced dose
NOAC, reduced dose
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Vitamin K antagonists (VKA)
Participants with NVAF initiating treatment with vitamin K antagonists (VKA)
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VKA
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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
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Number of participants with intracranial haemorrhage (ICH)
Time Frame: Retrospective analysis from 2010 - 2018
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Evaluation will be done in participants treated with reduced doses of individual NOACs and with VKA
|
Retrospective analysis from 2010 - 2018
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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
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Rivaroxaban
- Dabigatran
- Apixaban
- Warfarin
Other Study ID Numbers
- 20030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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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