Coronary Artery DiseaseARCACHONNCT04566497
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.
A study testing No stress testing and stress testing in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
- What is being tested?
- No stress testing and stress testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,664 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior coronary revascularization (PCI or CABG) at any time before randomization.
- Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
- Patient affiliated to Social Security
- Informed, written consent from the patient
Who cannot join
- Age < 18years
- Any acute coronary syndrome in the previous 3 months
- 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.
- Any severe valvular disease
Show all 14Show fewer
- Prior heart transplantation
- Class III or IV symptomatic heart failure (NYHA classification).
- 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
- Malignancies and other comorbid conditions with a life expectancy < 2 years
- Pregnancy or nursing women
- Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
- Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
- Being tested
- No stress testing, stress testing
- Keywords
- Stress testing, Myocardial ischemia, Coronary artery disease, coronary revascularization
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No stress testingOther
Also called Arm1
No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic
stress testingProcedure or surgery
Also called Arm 2
Systematic annual stress testing during the patient follow up (up to 48 months)
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | no systematic stress testing during follow-up Receives: Other: No stress testing |
| Active Comparator | Active comparator | systematic annual stress testing during follow-up Receives: Procedure: stress testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: minimum 24 months to 48 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: minimum 24 months to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start30 Sep 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,664 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadjib Hammoudi, MD PHD, Principal investigator, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566497
- Sponsor's protocol ID
- P170908J
- Acronym
- ARCACHON
- Status last verified
- Apr 2024
- First submitted
- 31 Aug 2020
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04566497
- Acronym / sponsor ID
- ARCACHON / P170908J
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting
- Keywords
- Stress testing, Myocardial ischemia, Coronary artery disease, coronary revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,664 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: No stress testingno systematic stress testing during follow-up |
| Active Comparator | Active comparator | Procedure: stress testingsystematic annual stress testing during follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior coronary revascularization (PCI or CABG) at any time before randomization.
- Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
- Patient affiliated to Social Security
- Informed, written consent from the patient
Key exclusion criteria (14 listed)
- Age < 18years
- Any acute coronary syndrome in the previous 3 months
- Symptoms suggestive of angina pectoris at the time of randomization:
- Any severe valvular disease
- Prior heart transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No stress testingAlso: Arm1No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic | Other | Experimental |
| stress testingAlso: Arm 2Systematic annual stress testing during the patient follow up (up to 48 months) | Procedure or surgery | Active Comparator |
Primary outcome
demonstrate the non-inferiority of a strategy of clinical follow-up
Time frame: minimum 24 months to 48 months
The primary outcomes measured at longest follow-up (minimum 24 months) the number of All-cause death in each arm
demonstrate the non-inferiority of a strategy of clinical follow-up
Time frame: minimum 24 months to 48 months
The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Myocardial infarction in each arm
demonstrate the non-inferiority of a strategy of clinical follow-up
Time frame: minimum 24 months to 48 months
The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Stroke in each arm hospitalization.
demonstrate the non-inferiority of a strategy of clinical follow-up
Time frame: minimum 24 months to 48 months
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
5 secondary outcomes
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Time frame: minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia
Time frame: minimum 24 months to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadjib Hammoudi, MD PHD principal investigator
APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No stress testing and stress testing in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadjib Hammoudi, MD PHD (01 42 16 55 35 ext. +33, nadjib.hammoudi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
demonstrate the non-inferiority of a strategy of clinical follow-up (time frame: minimum 24 months to 48 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.