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
Recruitment status was Active, not recruiting
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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:
- Three vessel disease recently identified recently (<6 month)
- Accrue coronary syndromes in patients>75 years old (<1 month)
Exclusion criteria:
- 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
Contacts and Locations
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 Myocardial Ischemia Coronary Disease Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on May 21, 2013