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

Study identification

• 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

Study timelines

Date when funding contract was signed

Planned:15/09/2021

Actual:15/09/2021

Study start date

Planned:02/12/2021

Actual:02/12/2021

Date of final study report

Planned:31/07/2022

Actual:26/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable