NCT00445835

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

March 8, 2007

Last Update Submit

January 17, 2020

Conditions

Keywords

coronary artery diseasemyocardial infarctionatherothrombosisatherosclerosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    during the study

Secondary Outcomes (1)

  • Incidence of each composite of the primary endpoint.

    during the study

Study Arms (2)

BA :Active arm

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

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

BC: Conservative arm

OTHER

Conservative medical approach

Other: Conservative arm

Interventions

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

BA :Active arm

Conservative medical approach

BC: Conservative arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Three vessel disease recently identified recently (\<6 month)
  • Accrue coronary syndromes in patients\>75 years old (\<1 month)

You may not qualify if:

  • Absence of significant coronary lesions
  • Other causes of rise in the troponin level
  • Patient\<18 years old
  • Pregnant women
  • Patient without affiliation to National Social Security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Pitie-Salpetriere

Paris, 75013, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionThrombosisAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and Thrombosis

Study Officials

  • Jean-Philippe COLLET, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 9, 2007

Study Start

September 1, 2007

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations