Acute Coronary SyndromeAReMISNCT01952392
Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in France.
Trial summary
Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 4,992 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Effectiveness study, Acute coronary Syndrome, Real-life, France
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Medical information
History of coagulation and vascular disorders History of cerebrovascular accidents Cardiovascular risk factors
Measured: At baseline visit
Drug exposure
Current exposure: within 24 hours (before date of recurrent MI). Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.
Measured: Current
Drug exposure
Recent exposure: in the week (7 days) preceding the recurrent MI. Exposure to clopidogrel, ticagrelor, prasugrel, aspirin, other antiplatelet drugs.
Measured: Recent
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.
Measured: Past
Secondary outcomes (1)
Other medical events of interest
rMI, stroke, bleeding, death
Measured: During follow-up (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952392
- Sponsor's protocol ID
- NIS-CFR-BRI-2012/1
- Acronym
- AReMIS
- Status last verified
- Feb 2017
- First submitted
- 21 Aug 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01952392
- Acronym / sponsor ID
- AReMIS / NIS-CFR-BRI-2012/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- Effectiveness study, Acute coronary Syndrome, Real-life, France
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,992 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevention of cardiovascular events by antiplatelet agents after 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Other medical events of interest
Time frame: During follow-up (up to 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- CSR\_SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical information (time frame: At baseline visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2017.