Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients (AMERICA)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds
Conservative arm
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, myocardial infarction, atherothrombosis, atherosclerosis
Eligibility Criteria
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
Sites / Locations
- Hopital Pitie-Salpetriere
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
BA :Active arm
BC: Conservative arm
Arm Description
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 medical approach
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of each composite of the primary endpoint.
Incidence of each composite of the primary endpoint.
Full Information
NCT ID
NCT00445835
First Posted
March 8, 2007
Last Updated
January 17, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut de l'Atherothrombose
1. Study Identification
Unique Protocol Identification Number
NCT00445835
Brief Title
Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2007 (Actual)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut de l'Atherothrombose
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, myocardial infarction, atherothrombosis, atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
526 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BA :Active arm
Arm Type
Other
Arm Description
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
Arm Title
BC: Conservative arm
Arm Type
Other
Arm Description
Conservative medical approach
Intervention Type
Other
Intervention Name(s)
Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conservative arm
Intervention Description
Conservative medical approach
Primary Outcome Measure Information:
Title
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
Description
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
Time Frame
during the study
Secondary Outcome Measure Information:
Title
Incidence of each composite of the primary endpoint.
Description
Incidence of each composite of the primary endpoint.
Time Frame
during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe COLLET, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29407124
Citation
Collet JP, Cayla G, Ennezat PV, Leclercq F, Cuisset T, Elhadad S, Henry P, Belle L, Cohen A, Silvain J, Barthelemy O, Beygui F, Diallo A, Vicaut E, Montalescot G; AMERICA Investigators. Systematic detection of polyvascular disease combined with aggressive secondary prevention in patients presenting with severe coronary artery disease: The randomized AMERICA Study. Int J Cardiol. 2018 Mar 1;254:36-42. doi: 10.1016/j.ijcard.2017.11.081. Epub 2018 Jan 28.
Results Reference
derived
Learn more about this trial
Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients
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