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Completed

NCT Number: NCT00445835

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

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

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Key information

About this 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Absence of significant coronary lesions
  • Other causes of rise in the troponin level
  • Patient<18 years old
  • Pregnant women
  • Patient without affiliation to National Social Security

Treatment and study plan

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

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

Conservative arm

Other

Conservative medical approach

Primary outcomes

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

    Time frame: during the study

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

Secondary outcomes

  1. Incidence of each composite of the primary endpoint.

    Time frame: during the study

    Incidence of each composite of the primary endpoint.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut de l'Atherothrombose

Registry information

Official study 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

Acronym: AMERICA

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2007
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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