An interventional study of No stress testing and stress testing in Coronary Artery Disease, Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.
ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.
Coronary artery revascularization is commonly used for the management strategy of patients with coronary artery disease (CAD).
In the following years after revascularization, the current guidelines recommend evaluation with stress tests when patients are symptomatic. Due to the lack of randomized trials, the evaluation of asymptomatic patients is controversial and accordingly there is a wide variation in routine follow-up strategies in these patients. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival We hypothesized that clinical follow-up alone would be non-inferior to systematic stress testing screening strategy during follow-up of asymptomatic CAD patients with prior coronary revascularization.
The primary objective of ARCACHON trial is to demonstrate the non-inferiority of a strategy of clinical follow-up (without non-invasive stress testing) in asymptomatic patients with a history of coronary revascularization compared to a strategy of systematic screening for myocardial ischemia using non-invasive stress testing by the primary endpoint as the composite of: all-cause death, myocardial infarction, stroke or any cardiovascular event leading to unplanned hospitalization.
5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 2,664 is above the median of 123 across 3,438 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Symptoms suggestive of angina pectoris at the time of randomization:
no systematic stress testing during follow-up
Other: No stress testing
systematic annual stress testing during follow-up
Procedure: stress testing
No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic
Also known as: Arm1
Systematic annual stress testing during the patient follow up (up to 48 months)
Also known as: Arm 2
demonstrate the non-inferiority of a strategy of clinical follow-up
The primary outcomes measured at longest follow-up (minimum 24 months) the number of All-cause death in each arm
Time frame: minimum 24 months to 48 months
demonstrate the non-inferiority of a strategy of clinical follow-up
The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Myocardial infarction in each arm
Time frame: minimum 24 months to 48 months
demonstrate the non-inferiority of a strategy of clinical follow-up
The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Stroke in each arm hospitalization.
Time frame: minimum 24 months to 48 months
demonstrate the non-inferiority of a strategy of clinical follow-up
The primary outcomes measured at longest follow-up (minimum 24 months) is the number of any cardiovascular event leading to unplanned hospitalization in each arm
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months) All-cause death, myocardial infarction
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Angina control per Seattle Angina Questionnaire
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Quality of life in each arm
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Urgent or unscheduled revascularizations in each arm
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Any cardiovascular event leading to unplanned hospitalization in each arm
Time frame: minimum 24 months to 48 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris