Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01952392
First received: August 21, 2013
Last updated: November 20, 2014
Last verified: November 2014
  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 ] [ Designated as safety issue: No ]
    History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors

  • Drug exposure [ Time Frame: Current ] [ Designated as safety issue: No ]
    Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.

  • Drug exposure [ Time Frame: Recent ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    rMI, stroke, bleeding, death


Estimated Enrollment: 3750
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952392

Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01952392     History of Changes
Other Study ID Numbers: NIS-CFR-BRI-2012/1
Study First Received: August 21, 2013
Last Updated: November 20, 2014
Health Authority: 'CNIL': French Data Protection Authority, France.
'HAS TC': Transparency Commission of the Haute Autorité de Santé (French National Authority for Health), France.
'CEPS': Committee for Pricing of Healthcare Products, France.

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

Additional relevant MeSH terms:
Myocardial Ischemia
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Platelet Aggregation Inhibitors
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014