Study identification

PURI

https://redirect.ema.europa.eu/resource/108399

EU PAS number

EUPAS107330

Study ID

108399

Official title and acronym

Thromboembolic events reported in association with idarucizumab and andexanet alfa: disproportionality analysis of the Food and Drugs Administration Adverse Eventr Resporting System (FAERS) database (Idarucizumab/andexanet alfa & thromboembolism)

DARWIN EU® study

No

Study countries

Italy

Study description

Idarucizumab and andexanet alfa are drugs for the emergency reversal of pharmacological effect of direct oral anticoagulant (DOAC) drugs. However, given the recent commercialization of these two antidotes (2015 for idarucizumab, 2018 for andexanet) and their rare use in clinical practice, evidence on the safety of idarucizumab regarding thromboembolic risk is still limited. The aim of this study is to analyze the Food and Drugs Administration Spontenouse Reporting System (FAERS) database for generating hypothesis on the possible association between the use of idarucizumab and specific thromboembolic events, which can be subsequently verified through ad hoc observational studies.

Study status

Ongoing
Research institution and networks

Institutions

Contact details

Roberto Giuseppe

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

ARS
Study protocol
Initial protocol

Idarucizumab_andexanet alfa_thromboebolic events_FAERS_v01_ENCEPP

English (937.54 KB - PDF)View document
Updated protocol

Idarucizumab_andexanet alfa_thromboebolic events_FAERS_v01_1_ENCEPP

English (940.16 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