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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01952392
First Posted: September 30, 2013
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

  • 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.

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


Enrollment: 4992
Study Start Date: October 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 21, 2013
First Posted: September 30, 2013
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