Active Detection of the Extension of Atherothrombosis in High Risk Coronary Patients

NCT ID: NCT00445835

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-04-30

Brief Summary

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Coronary artery disease is the first cause of death related to atherothrombosis.

Detailed Description

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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).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Arterial doppler for screening asymptomatic and significant extracoronary arterial stenoses in all arterial beds

Intervention Type OTHER

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

Group Type OTHER

Conservative arm

Intervention Type OTHER

Conservative medical approach

Interventions

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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

Intervention Type OTHER

Conservative arm

Conservative medical approach

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de l'Atherothrombose

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Philippe COLLET, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Pitie-Salpetriere

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 29407124 (View on PubMed)

Other Identifiers

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PHAO 2006

Identifier Type: -

Identifier Source: secondary_id

P060902

Identifier Type: -

Identifier Source: org_study_id

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