Study identification

PURI

https://redirect.ema.europa.eu/resource/15799

EU PAS number

EUPAS6355

Study ID

15799

Official title and acronym

Assessment of the effectiveness of risk minimisation measures set up for new safety information for Efient® (Prasugrel): a multinational survey among physicians to evaluate their knowledge and consideration of the new safety warning for Prasugrel in four European countries (H7T-MC-B021)

DARWIN EU® study

No

Study countries

France
Germany
Netherlands
United Kingdom

Study description

The research question is whether the new safety information included in the risk minimisation measures (Direct Healthcare Professional Communication (DHPC), international congress and journal publication) were effective in:• educating Healthcare Professionals (HCPs) about the increased bleeding risk when pre-treating with a loading dose of Efient® (prasugrel) prior to diagnostic coronary angiography in UA/NSTEMI patients, and• influencing their consideration of this risk when prescribing a loading dose of Efient® (prasugrel).

Study status

Finalised
Research institution and networks

Institutions

Contact details

Toussi Massoud

Primary lead investigator
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:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company and Daiichi Sankyo Company
Study protocol
Initial protocol

B021 RMiP PASS Protocol

English (628.84 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)