Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome (AReMIS)

February 23, 2017 updated by: AstraZeneca

Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome

Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

Study Overview

Status

Completed

Conditions

Detailed Description

AReMIS (Antiplatelet and Recurrent Myocardial Infarction Study) To compare the relative risk of new myocardial infarction (recurrent myocardial infarction or 'rMI') 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.

Study Type

Observational

Enrollment (Actual)

4992

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged 18 years or more, both genders,with an acute coronary syndrome, agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

Description

Inclusion Criteria:

Patients aged 18 years or more, both genders, with an acute coronary syndrome (ACS), agreed to participate and able to respond to an interview in French and/or providing the details of an alternative replier (proxy) if necessary.

No Exclusion Criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Patients aged 18 years or more with an acute coronary syndrome, agreed to participate and able to answer an interview in French and/or providing the details of an alternative replier (proxy) if necessary
Case group
Patients aged 18 years or more with a history of acute coronary syndrome (i.e. a recurrent MI after myocardial history or unstable angina), agreed to participate and able to answer an interview in French and/or providing the details of an alternative replier (proxy) if necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical information
Time Frame: At baseline visit
History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors
At baseline visit
Drug exposure
Time Frame: Current
Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.
Current
Drug exposure
Time Frame: Recent
Recent exposure: in the week (7 days) preceding the recurrent MI. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.
Recent
Drug exposure
Time Frame: Past
Past exposure: more than a week (7 days) before the recurrent MI and until the ACS index. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.
Past

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other medical events of interest
Time Frame: During follow-up (up to 12 months)
rMI, stroke, bleeding, death
During follow-up (up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimate)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CFR-BRI-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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