Trial Description. DRKS-ID: DRKS Date of Registration in DRKS: 2015/03/06 Date of Registration in Partner Registry: [---]*

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1 PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Treatment with new oral anticoagulants in primary care practices Trial Acronym [---]* URL of the trial [---]* Brief Summary in Lay Language For decades drugs from the group of coumarins (eg warfarin) serve to prevent complications such as Stroke in atrial fibrillation. With the so-called New oral anticoagulants (Pradaxa, Xarelto, Eliquis) are first alternative drugs available. According to the guideline of the German Society of General Practice and Family Medicine (DEGAM) these are to be used primarily in patients who are not well-adjust with the usual therapy with coumarins. But what about the practice? For what reasons patients are transferred to these new oral anticoagulants? How effective was the coumarin therapy at the time of the change? To find answers to these questions the present study investigates data from GP patients who have been prescribed in the past two years Pradaxa, Xarelto and Eliquis. Brief Summary in Scientific Language For decades, vitamin K antagonists (VKA) from the group of coumarins serve to prevent cardioembolic complications in non-valvular atrial fibrillation. With the new oral anticoagulants Dabigatran (Pradaxa ), Rivaroxaban (Xarelto) and Apixaban (Eliquis ) are first alternatives available. In the S1-guideline of the DEGAM (German Society of General Practice and Familiy Medicine) a change from a VKA to the new oral anticoagulants (NOAK) is not recommended for patients who can be easily treated with VKA. If TTR (= time in therapeutic range, a measure of quality of coumarin therapy; describes the percentage of time being in the therapeutic INR range) is > 72.6%, it is assumed that the NOAK are not clinically superior to the VKA. But what about the practice? The present retrospective study will examine this issue, calculating the TTR value at the time of a change from VKA to NOAK. Included are GP patients who have been prescribed in the past two years Pradaxa, Xarelto and Eliquis. The aim is to verify the application of the guideline for NOAK. Page 1 of 5

2 Organizational Data DRKS-ID: DRKS Date of Registration in Partner Registry or other Primary Registry: [---]* Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: 004/15, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn Secondary IDs Health condition or Problem studied ICD10: I48 - Atrial fibrillation and flutter Interventions/Observational Groups Arm 1: non-interventional retrospective observational study. Documentation of medical records of GP patients who have been prescribed new oral anticoagulants (Dabigatran (Pradaxa ), Rivaroxaban (Xarelto) and Apixaban (Eliquis )) in the last two years: Age, gender, medication, medical history, INR values, liver and kidney function. Characteristics Study Type: Non-interventional Study Type Non-Interventional: Observational study Allocation: Single arm study Blinding: [---]* Who is blinded: [---]* Control: Uncontrolled/Single arm Purpose: Treatment Assignment: Single (group) Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): No Page 2 of 5

3 Primary Outcome TTR at the time of a change from VKA to NOAK (calculation with a formula including INR values) Secondary Outcome Reason for the change of VKA to NOAK (information from the electronic patient data or personal conversation with the concerned doctor) Countries of recruitment DE Locations of Recruitment Doctor's Practice Bonn und Umgebung Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2015/02/05 Target Sample Size: 200 Monocenter/Multicenter trial: Multicenter trial National/International: National Inclusion Criteria Gender: Both, male and female Minimum Age: no minimum age Maximum Age: no maximum age Additional Inclusion Criteria GP patients who have been prescribed in the past two years one of the drugs of Pradaxa, Xarelto and Eliquis Exclusion criteria Duration of warfarin-taking before changing to the new oral anticoagulants <6 months Page 3 of 5

4 Duration of warfarin-taking before changing to the new oral anticoagulants <6 months Addresses Primary Sponsor Universitätsklinikum Bonn Sigmund-Freud-Str. 25 Telephone: [---]* [---]* URL: Contact for Scientific Queries Mr. Prof. Dr. med. Klaus Weckbecker Sigmund-Freud-Str. 25 Telephone: Klaus.Weckbecker at ukb.uni-bonn.de Contact for Public Queries Ms. Bettina Weber Siegmund-Freud-Str. 25 Telephone: 0228/ Fax: 0228/ Bettina.Weber at ukb.uni-bonn.de Page 4 of 5

5 Sources of Monetary or Material Support Institutional budget, no external funding (budget of sponsor/pi) Telephone: [---]* [---]* Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Trial Publications, Results and other documents * This entry means the parameter is not applicable or has not been set. Page 5 of 5