Study identification

PURI

https://redirect.ema.europa.eu/resource/38061

EU PAS number

EUPAS38060

Study ID

38061

Official title and acronym

Drug-drug interactions between dicloxacillin/flucloxacillin and DOACs

DARWIN EU® study

No

Study countries

Denmark
Netherlands

Study description

Direct 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.

Study status

Planned
Research institution and networks

Institutions

Contact details

Anton Pottegård

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

Data collection

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

None
Study protocol
Initial protocol

Protocol-EU-PAS

English (717.17 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable