Coronary Artery DiseaseAMERICANCT00445835
Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients
A study testing Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds and Conservative arm in people with Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Coronary artery disease is the first cause of death related to atherothrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds and Conservative arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Apr 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Three vessel disease recently identified recently (<6 month)
- Accrue coronary syndromes in patients>75 years old (<1 month)
Who cannot join
- Absence of significant coronary lesions
- Other causes of rise in the troponin level
- Patient<18 years old
- Pregnant women
- Patient without affiliation to National Social Security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Active Detection and Management of the Extension of Atherothrombosis in High Risk Coronary Patients In Comparison With Standard of Care for Coronary Atherosclerosis: The AMERICA Study
Coronary artery disease is the first cause of death related to atherothrombosis.
Read the detailed description
Coronary artery disease is the first cause of death related to atherothrombosis. There is a close correlation between the extension of coronary artery disease and the severity of atherosclerotic lesions in extra coronary arterial beds. In addition, these symptomatic extracoronary lesions dramatically decrease the survival of these patients. However, scant data are available regarding the prevalence of extracoronary asymptomatic lesions. Conversely, the annual absolute risk of these lesions remains unknown. Consequently, whether a systematic identification of these extracoronary asymptomatic lesions is relevant remains to be established. The Primary Objective and Primary Endpoint of the AMERICA study is to demonstrate the superiority of an active detection and management of the extension of atherothrombosis in high Risk coronary patients (active strategy) in comparison with standard of care for coronary atherosclerosis (conservative strategy).
- Conditions
- Coronary Artery Disease
- Being tested
- Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds, Conservative arm
- Keywords
- coronary artery disease, myocardial infarction, atherothrombosis, atherosclerosis
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Thrombosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial bedsOther
A strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis
Conservative armOther
Conservative medical approach
| Study group | Role | What they receive |
|---|---|---|
| BA :Active arm | Other | A strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis Receives: Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds |
| BC: Conservative arm | Other | Conservative medical approach Receives: Other: Conservative arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
Measured: during the study
Secondary outcomes (1)
Incidence of each composite of the primary endpoint.
Incidence of each composite of the primary endpoint.
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de l'Atherothrombose
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe COLLET, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445835
- Sponsor's protocol ID
- P060902
- Other IDs
- PHAO 2006
- Acronym
- AMERICA
- Status last verified
- Jan 2020
- First submitted
- 8 Mar 2007
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Collet JP, Cayla G, Ennezat PV, Leclercq F, Cuisset T, Elhadad S, Henry P, Belle L, Cohen A, Silvain J, Barthelemy O, Beygui F, Diallo A, Vicaut E, Montalescot G; AMERICA Investigators. Systematic detection of polyvascular disease combined with aggressive secondary prevention in patients presenting with severe coronary artery disease: The randomized AMERICA Study. Int J Cardiol. 2018 Mar 1;254:36-42. doi: 10.1016/j.ijcard.2017.11.081. Epub 2018 Jan 28.
PubMed 29407124
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Detection and Management of the Extension of Atherothrombosis in High Risk Coronary Patients In Comparison With Standard of Care for Coronary Atherosclerosis: The AMERICA Study
- ClinicalTrials.gov ID
- NCT00445835
- Acronym / sponsor ID
- AMERICA / P060902
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, myocardial infarction, atherothrombosis, atherosclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut de l'Atherothrombose
- Study start
- Sep 2007 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Mar 2007 (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.
Coronary artery disease is the first cause of death related to atherothrombosis.
Detailed description
Coronary artery disease is the first cause of death related to atherothrombosis. There is a close correlation between the extension of coronary artery disease and the severity of atherosclerotic lesions in extra coronary arterial beds. In addition, these symptomatic extracoronary lesions dramatically decrease the survival of these patients. However, scant data are available regarding the prevalence of extracoronary asymptomatic lesions. Conversely, the annual absolute risk of these lesions remains unknown. Consequently, whether a systematic identification of these extracoronary asymptomatic lesions is relevant remains to be established. The Primary Objective and Primary Endpoint of the AMERICA study is to demonstrate the superiority of an active detection and management of the extension of atherothrombosis in high Risk coronary patients (active strategy) in comparison with standard of care for coronary atherosclerosis (conservative strategy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BA :Active arm | Other | Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial bedsA strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis |
| BC: Conservative arm | Other | Other: Conservative armConservative medical approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Three vessel disease recently identified recently (<6 month)
- Accrue coronary syndromes in patients>75 years old (<1 month)
Key exclusion criteria (5 listed)
- Absence of significant coronary lesions
- Other causes of rise in the troponin level
- Patient<18 years old
- Pregnant women
- Patient without affiliation to National Social Security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial bedsA strategy of systematic screening of these extra-coronary asymptomatic lesions combined with a specific treatment if needed and an aggressive secondary prevention pharmacological treatment of atherothrombosis | Other | BA :Active arm |
| Conservative armConservative medical approach | Other | BC: Conservative arm |
Primary outcome
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
Time frame: during the study
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
1 secondary outcome
Incidence of each composite of the primary endpoint.
Time frame: during the study
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 22 Jan 2020.
- Derived from this study: PubMed 29407124Collet JP, Cayla G, Ennezat PV, Leclercq F, Cuisset T, Elhadad S, Henry P, Belle L, Cohen A, Silvain J, Barthelemy O, Beygui F, Diallo A, Vicaut E, Montalescot G; AMERICA Investigators. Systematic detection of polyvascular disease combined with aggressive secondary prevention in patients presenting with severe coronary artery disease: The randomized AMERICA Study. Int J Cardiol. 2018 Mar 1;254:36-42. doi: 10.1016/j.ijcard.2017.11.081. Epub 2018 Jan 28.
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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.
Jean-Philippe COLLET, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds and Conservative arm in people with Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris 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 5 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 22 Jan 2020. 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?
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure. (time frame: during the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00445835, which also lists 1 linked publication.
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 22 Jan 2020.