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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds; Other: Conservative arm

• Registration Number: NCT00445835
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2007-03-08
• Study First Submitted QC: 2007-03-08
• Study First Posted: 2007-03-09
• Study Start: 2007-09
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 526

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BA :Active arm	Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds	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
BC: Conservative arm	Conservative arm	Conservative medical approach

Primary Outcome Measures

Name	Time	Method
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.	during the study	death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.

Secondary Outcome Measures

Name	Time	Method
Incidence of each composite of the primary endpoint.	during the study	Incidence of each composite of the primary endpoint.

Trial Locations

Locations (1)

Hopital Pitie-Salpetriere; 🇫🇷 Paris, France