STUDY ON THE PREVENTION OF CARDIOVASCULAR EVENTS BY ANTIPLATELET AGENTS AFTER ACUTE CORONARY SYNDROME (AReMIS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17589
• EU PAS number:
  EUPAS5905
• Study ID:
  17589
• Official title and acronym:
  STUDY ON THE PREVENTION OF CARDIOVASCULAR EVENTS BY ANTIPLATELET AGENTS AFTER ACUTE CORONARY SYNDROME (AReMIS)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The Primary objective of this study is to compare the relative risk of new myocardial infarction (MI) or cardiac death in patients with a history of acute coronary syndrome ('ACS': unstable angina or myocardial infarction), using ticagrelor, clopidogrel or prasugrel (if applicable) or none of these treatments, where aspirin is considered a covariate. Secondary objectives include the estimation of the incidence rates among patients with a history of acute coronary syndrome (unstable angina or myocardial infarction), exposed to the use of ticagrelor, clopidogrel, prasugrel, or none of these treatments, of the following events: recurrent myocardial infarction (rMI), stroke, major bleeding (requiring hospitalization) and non-major and death, to describe patterns of use for ticagrelor and other antiplatelet agents (indication, substitutions, etc.), including the discontinuation of treatment and reasons, and to study the influence of risk factors on the risk of cardiovascular events in participating patients and assess how these factors interact with ticagrelor and other antiplatelet drugs.The study design is a general cohort of patients with acute coronary syndrome (ACS) followed for 12 months for the occurrences of interest. A case-cohort analysis will compare drug exposure between patients who have had an occurrence of interest to those who did not (population-time with no event). Medical information at baseline is entered by cardiologists in the PGRx system. Drug exposure is obtained from cardiologists and patients through standardized and validated telephone interviews. Events of interest are examined by an adjudication committee. A total of 3,750 patients with ACS will be needed to achieve a power of 80% to detect an Odds ration inferior to 0.8 for the comparison ticagrelor to the each of clopidogrel and prasugrel, assuming approximately equal exposure in the population of interest.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Real World Studies, LA-SER Research

France

United Kingdom

Networks

PGRx®

France

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 23/11/2012

Study start date

Planned: 01/09/2013

Actual: 04/10/2013

Date of final study report

Planned: 20/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra-Zeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable