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

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ClinicalTrials.gov Identifier: NCT01952392
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

Condition or disease
Acute Coronary Syndrome

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 Design

Study Type : Observational
Actual Enrollment : 4992 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
Study Start Date : October 2013
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Medical information [ Time Frame: At baseline visit ]
    History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors

  2. Drug exposure [ Time Frame: Current ]
    Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Other medical events of interest [ Time Frame: During follow-up (up to 12 months) ]
    rMI, stroke, bleeding, death


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952392


Locations
France
Research Site
Paris, France
Sponsors and Collaborators
AstraZeneca
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01952392     History of Changes
Other Study ID Numbers: NIS-CFR-BRI-2012/1
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by AstraZeneca:
Effectiveness study
Acute coronary Syndrome
Real-life
France

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors