An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 2 sites in 2 countries. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by Bayer · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 64 studies in Atrial Fibrillation by Bayer — 1 open to participants now, 1 under way, none of them phase 3. Atrial Fibrillation · Bayer.
Among the 64 studies in Atrial Fibrillation by Bayer, this one is the 31st largest by enrollment of the 51 observational ones that give a count, is one of 6 that started in 2017, is one of 51 observational ones, and was the 43rd registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.
Browse Atrial Fibrillation studies →1 of the 64 studies in Atrial Fibrillation by Bayer is open now, in 8 countries. Recruiting first, the newest first:
Bayer · Sites in United States, Belgium, Bulgaria and 5 more countries
Ages 18–85
By country, each count listing its studies:
Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
64 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,216 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Median enrollment 100 across the 13 interventional studies, 3,055 across the 51 observational. Of the 61 that completed or were terminated, 4 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 64 studies in Atrial Fibrillation by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to collect additional information of Xarelto treatment in routine clinical practice. Patients affected by atrial fibrillation and who will get Xarelto as a prophylactic treatment against stroke and systemic embolism (Stroke Prevention in Atrial Fibrillation) will be observed.
The study takes place in Korea and Taiwan. Approximately a total of 1200 patients will be included in the study within 12 months. The observation period for each patient is 1 year from enrollment into the study, or until withdrawal of consent or lost to follow-up. Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.
Patients from Taiwan and Korea visiting doctors in hospitals or medical practices for treatment of atrial fibrillation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions. NVAF: Non-valvular atrial fibrillation
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function
Major bleeding events, collected as Serious Adverse Events (SAEs) or non-serious Adverse Events (AEs)
Major bleeding events, collected as SAEs or non-serious AEs and defined as overt bleeding associated with: * A fall in hemoglobin of ≥2 g/dL, or * A transfusion of ≥2 units of packed red blood cells or whole blood, or * Occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or * Death.
Time frame: Up to one year
AEs
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Time frame: Up to one year
SAEs
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Time frame: Up to one year
All-cause mortality
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Time frame: Up to one year
Non-major bleeding events
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Time frame: Up to one year
Symptomatic thromboembolic events
All events which do not fall under characterization of major bleeding events as explained in section "primary outcome variables"
Time frame: Up to one year
Start of rivaroxaban therapy and, if applicable, stop of rivaroxaban therapy
Start date and stop date will be collected to receive information on drug persistence
Time frame: Up to one year
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Ran from Sep 2017 to primary completion in Aug 2019, 22 months.
Of 148 industry-sponsored observational studies under Atrial Fibrillation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 42. This study's 22 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.