Status: Planned First registered on: 16/11/2020
Last updated on: 16/11/2020
1. Study identification
EU PAS Register NumberEUPAS38060
Official titleDrug-drug interactions between dicloxacillin/flucloxacillin and DOACs
Study title acronym
Study typeObservational study
Brief description of the studyDirect oral anticoagulants (DOACs) are a group of anticoagulants that include dabigatran, rivaroxaban, apixaban, and edoxaban. They are used to reduce the risk of stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF) and as prophylaxis against deep vein thrombosis (DVT) and pulmonary embolism (PE). They were developed as alternatives to vitamin-K antagonists (VKA) such as warfarin, and studies have shown that they are just as safe and effective in prevention of stroke in patients with NVAF. DOACs are more convenient than warfarin due to wider therapeutic range meaning that routine blood tests are not required. Previous studies have investigated co-administration of dicloxacillin and warfarin, which leads to higher risk of strokes and SE. Wether or not a similar association between DOACs and dicloxacillin/flucloxacillin exists, has never been assessed. With this cohort study we aim to investigate if co-administration of dicloxacillin/flucloxacillin leads to increased risk of strokes or SE in patients using DOACs.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUniversity of Southern Denmark Pharmacoepi center
Department/Research groupUniversity of Southern Denmark Pharmacoepi center
Organisation/affiliationUniversity of Southern Denmark
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name Pottegård
First name Anton
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Countries in which this study is being conducted
International study

Denmark
Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/11/2020
Start date of data collection01/01/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report02/08/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherNone100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Pottegård
First name Anton
Address line 1JB Winsløwsvej 19,2
Address line 2 
Address line 3 
CityOdense C 
Postcode5000 
CountryDenmark
Phone number (incl. country code)45-65503024 
Alternative phone number 
Fax number (incl. country code) 
Email address apottegaard@health.sdu.dk
Public Enquiries
Title Professor 
Last name Pottegård 
First name Anton 
Address line 1JB Winsløwsvej 19,2 
Address line 2 
Address line 3 
CityOdense C 
Postcode5000 
CountryDenmark 
Phone number (incl. country code)45-65503024 
Alternative phone number 
Fax number (incl. country code) 
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