Status: Planned First registered on: 23/09/2020
Last updated on: 23/09/2020
1. Study identification
EU PAS Register NumberEUPAS37318
Official titleImpact of the COVID-19 pandemic in a cohort of anticoagulant users: a descriptive drug utilization study based on data from the Tuscany Healthcare administrative database
Study title acronym
Study typeObservational study
Brief description of the studyThe rapid spread all over the world of the SARS-COV-2 forced all healthcare professionals to urgently reconsider the management of patients requiring continuing access to healthcare services such as patients treated with anticoagulants. Little is know on the impact of COVID-19 pandemic in the management of patients under anticoagulants treatment. Therefore, the aim of this study is to describe the use of anticoagulants in a large sample of the Italian population. For this purpose, electronic health records of Tuscany will be analyzed.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCESP
Department/Research groupCenter for Public Health Research
Organisation/affiliationUniversity of Milan Bicocca
Website/Homepagehttp://www.centrosanitapubblica.it/
Details of (Primary) lead investigator
Title Dr
Last name Antonazzo
First name Ippazio Cosimo
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

ARS
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/07/2020
Start date of data collection01/10/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report21/12/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherThis is an independent study based on a spontaneous initiative of the participanting partners100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Antonazzo
First name Ippazio Cosimo
Address line 1Via Cadore 48
Address line 2 
Address line 3 
CityMonza 
Postcode20090 
CountryItaly
Phone number (incl. country code)390392332678 
Alternative phone number 
Fax number (incl. country code) 
Email address ippazio.antonazzo@unimib.it
Public Enquiries
Title Dr 
Last name Antonazzo 
First name Ippazio Cosimo 
Address line 1Via Cadore 48 
Address line 2 
Address line 3 
CityMonza 
Postcode20090 
CountryItaly 
Phone number (incl. country code)390392332678 
Alternative phone number 
Fax number (incl. country code) 
Email address ippazio.antonazzo@unimib.it 
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