Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000168

EU PAS number

EUPAS1000000168

Study ID

1000000168

Official title and acronym

Exploring mediation through major bleeding between direct oral anticoagulants and cardiovascular events (MB mediation in CV RWE)

DARWIN EU® study

No

Study countries

United States

Study description

This multi-database observational study will estimate the extent to which the effect of direct oral anticoagulants versus warfarin on cardiovascular outcomes is mediated through their differential impact on extracranial MB rates. This causal mediation analysis will utilize real-world data and novel advanced statistical techniques to model the mediation effects, controlling for confounding factors that could influence both bleeding risk and cardiovascular outcomes. Causal validity study diagnostics with have been applied during protocol development to support evidence reliability.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Martijn Schuemie

Primary lead investigator
ORCID number:
0000-0002-0817-5361
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Initial protocol

Schuemie Yuan Weaver Barnathan - MB mediation in CV RWE.pdf

English (11.78 MB - 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