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

January 17, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hôpital Pitié-Salpétrière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: BC: Conservative arm
Conservative medical approach
Other: Conservative arm
Conservative medical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of each composite of the primary endpoint.
Time Frame: during the study
Incidence of each composite of the primary endpoint.
during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut de l'Atherothrombose

Investigators

  • Principal Investigator: Jean-Philippe COLLET, MD PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2007

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

March 8, 2007

First Submitted That Met QC Criteria

March 8, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P060902
  • PHAO 2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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