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. 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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Behavioral: arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds

Primary Measures

• death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.

Secondary Measures

• Incidence of each composite of the primary endpoint.

Inclusion criteria:

• 1. Three vessel disease recently identified recently (<1 month)
• 2. Actue 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Overall Clinical Trial Officials and Contacts

Jean-Philippe COLLET, MD PhD Principal Investigator Assistance Publique - Hôpitaux de Paris  

Overall Contact: Jean-Philippe COLLET, MD PhD +33 1 42 16 29 62 jean-philippe.collet@psl.aphp.fr

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00445835

Study ID Number: P060902

ClinicalTrials.gov Identifier: NCT00445835

Health Authority: France: Ministry of Health