Clinical trial NCT00445835: Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
myocardial infarction
atherothrombosis
atherosclerosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut de l'Atherothrombose
First posted: 2007-03-09
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: Inclusion criteria:

1. Three vessel disease recently identified recently (\<6 month)
2. Accrue coronary syndromes in patients\>75 years old (\<1 month)

Exclusion criteria:

1. Absence of significant coronary lesions
2. Other causes of rise in the troponin level
3. Patient\<18 years old
4. Pregnant women
5. Patient without affiliation to National Social Security

Primary outcomes:
measure: death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
timeFrame: during the study
Secondary outcomes:
measure: Incidence of each composite of the primary endpoint.
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Philippe COLLET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.