Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients

Study Overview
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Brief Summary
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Coronary artery disease is the first cause of death related to atherothrombosis.

Detailed Description
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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).

Official Title
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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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds
* Other: Conservative arm


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Three vessel disease recently identified recently (<6 month) Accrue coronary syndromes in patients>75 years old (<1 month) Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BA :Active arm<br>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 | Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds<br>* 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<br>|
| Other: BC: Conservative arm<br>Conservative medical approach | Other: Conservative arm<br>* Conservative medical approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of each composite of the primary endpoint. | Incidence of each composite of the primary endpoint. | during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, myocardial infarction, atherothrombosis, atherosclerosis