Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients (AMERICA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds; Other: Conservative arm

Study type: Interventional

Funder types: Other

Identifiers

NCT00445835

P060902

PHAO 2006

Details and patient eligibility

About

Coronary artery disease is the first cause of death related to atherothrombosis.

Full 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).

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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526 participants in 2 patient groups

BA :Active arm

Other group

Description:

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

Treatment:

Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds

BC: Conservative arm

Other group

Description:

Conservative medical approach

Treatment:

Other: Conservative arm