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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445835
First Posted: March 9, 2007
Last Update Posted: October 1, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut de l'Atherothrombose
Information provided by:
Assistance Publique - Hôpitaux de Paris
  Purpose
Coronary artery disease is the first cause of death related to atherothrombosis.

Condition Intervention
Coronary Artery Disease Other: Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds Other: Conservative arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Incidence of each composite of the primary endpoint. [ Time Frame: during the study ]
    Incidence of each composite of the primary endpoint.


Enrollment: 526
Study Start Date: September 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
BC: Conservative arm
Conservative medical approach
Other: Conservative arm
Conservative medical approach

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445835


Locations
France
Hopital Pitie-Salpetriere
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut de l'Atherothrombose
Investigators
Principal Investigator: Jean-Philippe COLLET, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Yannick Vacher, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00445835     History of Changes
Other Study ID Numbers: P060902
PHAO 2006
First Submitted: March 8, 2007
First Posted: March 9, 2007
Last Update Posted: October 1, 2010
Last Verified: September 2010

Keywords provided by Assistance Publique - Hôpitaux de Paris:
coronary artery disease
myocardial infarction
atherothrombosis
atherosclerosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases