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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01952392
Other study ID # NIS-CFR-BRI-2012/1
Secondary ID
Status Completed
Phase N/A
First received August 21, 2013
Last updated February 23, 2017
Start date October 2013
Est. completion date March 2016

Study information

Verified date February 2017
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome


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.


Recruitment information / eligibility

Status Completed
Enrollment 4992
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Research Site Paris

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medical information History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors At baseline visit
Primary Drug exposure Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs. Current
Primary Drug exposure Recent exposure: in the week (7 days) preceding the recurrent MI. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs. Recent
Primary Drug exposure 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 Other medical events of interest rMI, stroke, bleeding, death During follow-up (up to 12 months)
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