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Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients (AMERICA)

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ClinicalTrials.gov Identifier: NCT00445835
Recruitment Status : Unknown
Verified September 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
First Posted : March 9, 2007
Last Update Posted : October 1, 2010
Sponsor:
Collaborator:
Institut de l'Atherothrombose
Information provided by:
Assistance Publique - Hôpitaux de Paris

March 8, 2007
March 9, 2007
October 1, 2010
September 2007
December 2012   (Final data collection date for primary outcome measure)
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.
death (all cause) or any ischemic event leading to rehospitalisation or any evidence of organ failure.
Complete list of historical versions of study NCT00445835 on ClinicalTrials.gov Archive Site
Incidence of each composite of the primary endpoint. [ Time Frame: during the study ]
Incidence of each composite of the primary endpoint.
Incidence of each composite of the primary endpoint.
Not Provided
Not Provided
 
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
Coronary artery disease is the first cause of death related to atherothrombosis.
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).
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • Other: Conservative arm
    Conservative medical approach
  • BA :Active arm
    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: Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds
  • BC: Conservative arm
    Conservative medical approach
    Intervention: Other: Conservative arm
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
526
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00445835
P060902
PHAO 2006
Yes
Not Provided
Not Provided
Yannick Vacher, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Institut de l'Atherothrombose
Principal Investigator: Jean-Philippe COLLET, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP