Risk of subsequent cardiovascular events in patients discharged after myocardial infarction - Perseus (PERSEUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47380
• EU PAS number:
  EUPAS8205
• Study ID:
  47380
• Official title and acronym:
  Risk of subsequent cardiovascular events in patients discharged after myocardial infarction - Perseus (PERSEUS)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  Myocardial infarction affects about 5000 patients in Finland per year. Almost 20% of them die within one year after the event. Among the Nordic countries, cardiovascular death rates are the highest in Finland. Current guidelines advise to treat myocardial infarction patients with 12-month dual antiplatelet treatment. An ongoing PEGASUS-TIMI 54 clinical study aims to survey the advantages of longer use of ticagrelor and acetylsalicylic acid in secondary prevention. The aim of the present study is to describe the risk development and risk factors of subsequent cardiovascular events in patients discharged from hospital after myocardial infarction. The study questions focus on patients surviving more than one year without subsequent myocardial infarction or stroke and on patients with known additional risk factors. Pre-specified subgroup analyses in populations mimicking the PEGASUS-TIMI 54 study population in a real-life setting will be performed to enable comparison of real-life and randomised study settings.
• Study status:
  Finalised

Research institution and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 04/11/2014

Study start date

Planned: 01/09/2015

Actual: 12/08/2015

Data analysis start date

Planned: 01/09/2015

Actual: 15/10/2015

Date of final study report

Planned: 30/06/2016

Actual: 17/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca Nordic Baltic

Study protocol

Initial protocol

ER-9502_AZ PERSEUS_protocol for pharmacoepidemiological study_v10_20150402

Updated protocol

ER-9502_AZ PERSEUS_protocol for pharmacoepidemiological study_v10_20150402_signatures

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Astra Zeneca: D1843R00244, EPID Research: ER-9502