Status: Planned First registered on: 24/03/2023
Last updated on: 27/03/2023
1. Study identification
EU PAS Register NumberEUPAS103990
Official titlePost-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries
Study title acronym
Study typeObservational study
Brief description of the studyAs part of the risk management plan for rimegepant in Europe, this post-authorisation safety study (PASS) is being conducted to evaluate whether there is an increased risk of major adverse cardiovascular events (MACE) among patients with migraine and history of cardiovascular disease (CVD) initiating treatment with rimegepant compared with that among patients with migraine, with history of CVD, and being treated with other treatments for migraine, either continuing the current treatment or initiating a new one, other than rimegepant. The study will also describe the use of rimegepant in the initial years after approval in the same population.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)NA
Other study registration identification numbers and URLs as applicableNA
2. Research centres and Investigator details
Coordinating study entity
Centre namePfizer
Centre locationUnited States
Details of (Primary) lead investigator
Title Dr
Last name Monica
First name Bertoia
Is this study being carried out with the collaboration of a research network?
Yes
RTI
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Denmark
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/03/202301/03/2023
Start date of data collection01/10/2025
Start date of data analysis
Date of interim report, if expected
Date of final study report01/04/2029
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Monica
First name Bertoia
Address line 166 Hudson Boulevard East
Address line 2 
Address line 3 
CityNew York 
Postcode10001 
CountryUnited States
Phone number (incl. country code)16178176148 
Alternative phone number 
Fax number (incl. country code) 
Email address monica.bertoia@pfizer.com
Public Enquiries
Title Dr 
Last name Monica 
First name Bertoia 
Address line 166 Hudson Boulevard East 
Address line 2 
Address line 3 
CityNew York 
Postcode10001 
CountryUnited States 
Phone number (incl. country code)16178176148 
Alternative phone number 
Fax number (incl. country code) 
Email address monica.bertoia@pfizer.com 
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