Study identification

PURI

https://redirect.ema.europa.eu/resource/48920

EU PAS number

EUPAS43329

Study ID

48920

Official title and acronym

Observational Studies in Cancer Associated Thrombosis for Rivaroxaban – United Kingdom Cohort (OSCAR—UK)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

Patients with cancer are more likely than those without cancer to develop blood clots (deep vein thrombosis and pulmonary embolism), which are treated using blood thinners (anticoagulants). When clots occur, cancer patients carry a higher risk of recurring clots and more likely to bleed on blood thinning treatments. Therefore, it is critical to use blood thinners that optimize the safety and benefits. There are two main types of blood thinners that are recommended. The tablets which are direct-acting oral anticoagulants and the injections (low molecular-weight heparin). Clinical trials show the tablets may reduce clot risk but may potentially lead to more frequent bleeding, particularly in those with certain risk factors such as stomach ulcers, previous bleeding problems, certain cancer type. We aim to examine the effectiveness and safety of the tablets versus the injections for treatment of clots in cancer patients, to better understand these treatments' benefits and risks.

Study status

Finalised
Research institutions and networks

Institutions

Bayer AG
First published:
01/02/2024
Institution

Contact details

Bayer Clinical Trials BAYER AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Study protocol
Initial protocol

22020_Study Protocol_Redacted_V1.0_2021-08-23

English (522.21 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