Clinical trial NCT04566497: Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
Official title: Assessment in a Randomized Controlled Trial of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Coronary Artery Bypass Grafting
Keywords: Stress testing
Myocardial ischemia
Coronary artery disease
coronary revascularization
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 2664
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Prior coronary revascularization (PCI or CABG) at any time before randomization.
2. Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
3. Patient affiliated to Social Security
4. Informed, written consent from the patient

Exclusion Criteria:

1. Age \< 18years
2. Any acute coronary syndrome in the previous 3 months
3. Symptoms suggestive of angina pectoris at the time of randomization:

   * Angina is characterized by ischemic chest pain occurring on exertion or stress relieved by rest and/or nitroglycerine.
   * Angina equivalents are defined as dyspnea, fatigue, or diaphoresis on exertion evaluated by the principal investigator as abnormal and attributable to myocardial ischemia.
4. Any severe valvular disease
5. Prior heart transplantation
6. Class III or IV symptomatic heart failure (NYHA classification).
7. Persons whose occupations impact on public safety (e.g. airline pilots, lorry or bus drivers) in whom systematic stress testing could be required for medico-legal reasons
8. Malignancies and other comorbid conditions with a life expectancy \< 2 years
9. Pregnancy or nursing women
10. Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
11. Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden
12. Inability to sign an informed consent. Patient under legal protection (guardianship, curatorship) or mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent

Primary outcomes:
measure: demonstrate the non-inferiority of a strategy of clinical follow-up
timeFrame: minimum 24 months to 48 months
measure: demonstrate the non-inferiority of a strategy of clinical follow-up
timeFrame: minimum 24 months to 48 months
measure: demonstrate the non-inferiority of a strategy of clinical follow-up
timeFrame: minimum 24 months to 48 months
measure: demonstrate the non-inferiority of a strategy of clinical follow-up
timeFrame: minimum 24 months to 48 months
Secondary outcomes:
measure: compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
timeFrame: minimum 24 months to 48 months
measure: compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
timeFrame: minimum 24 months to 48 months
measure: compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
timeFrame: minimum 24 months to 48 months
measure: compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
timeFrame: minimum 24 months to 48 months
measure: compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
timeFrame: minimum 24 months to 48 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie salpetriere
Study officials:
affiliation: APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
name: Nadjib Hammoudi, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: