Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds, conservative arm
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Institut de l'Atherothrombose
Start date September 2007
End date December 2012
Trial size 526 participants
Trial identifier NCT00445835, P060902, PHAO 2006

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
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
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
(Other)
Conservative medical approach
conservative arm
Conservative medical approach

Primary Outcomes

Measure
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
time frame: during the study

Secondary Outcomes

Measure
Incidence of each composite of the primary endpoint.
time frame: during the study

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Jean-Philippe COLLET, MD PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.