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

Coronary Artery Disease Clinical Trial

— AMERICA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445835
• Other study ID #: P060902
• Secondary ID: PHAO 2006
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Est. completion date: April 2013

Study information

• Verified date: January 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 526
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• 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
• Conservative arm
Conservative medical approach

Locations

Country	Name	City	State
France	Hopital Pitie-Salpetriere	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut de l'Atherothrombose

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.	death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.	during the study
Secondary	Incidence of each composite of the primary endpoint.	Incidence of each composite of the primary endpoint.	during the study