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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00445835

Acronym

AMERICA

Enrollment

526

Registered

2007-03-09

Start date

2007-09-30

Completion date

2013-04-30

Last updated

2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, myocardial infarction, atherothrombosis, atherosclerosis

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).

Interventions

OTHERArterial 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

OTHERConservative arm

Conservative medical approach

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Incidence of each composite of the primary endpoint.	during the study	Incidence of each composite of the primary endpoint.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026