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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 because the information has not been verified recently.
Verified September 2010 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Institut de l'Atherothrombose
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00445835
First received: March 8, 2007
Last updated: September 30, 2010
Last verified: September 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yannick Vacher, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00445835     History of Changes
Other Study ID Numbers: P060902, PHAO 2006
Study First Received: March 8, 2007
Last Updated: September 30, 2010
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 20, 2014