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.

Coronary Artery Disease Clinical Trial

— ARCACHON  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04566497
• Other study ID #: P170908J
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nadjib Hammoudi, MD PHD
• Phone: 01 42 16 55 35
• Email: nadjib.hammoudi[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2664
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Other:
• No stress testing
No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic

Procedure:
• stress testing
Systematic annual stress testing during the patient follow up (up to 48 months)

Locations

Country	Name	City	State
France	Pitie salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	minimum 24 months to 48 months
Primary	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	minimum 24 months to 48 months
Primary	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.	minimum 24 months to 48 months
Primary	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	minimum 24 months to 48 months
Secondary	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	minimum 24 months to 48 months
Secondary	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	minimum 24 months to 48 months
Secondary	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	minimum 24 months to 48 months
Secondary	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	minimum 24 months to 48 months
Secondary	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	minimum 24 months to 48 months