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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. (ARCACHON)

Primary Purpose

Coronary Artery Disease, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

No stress testing

stress testing

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Stress testing, Myocardial ischemia, Coronary artery disease, coronary revascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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
Contemporaneous enrollment in a different clinical trial
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

Sites / Locations

Pitie salpetriereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Active Comparator

Arm Description

no systematic stress testing during follow-up

systematic annual stress testing during follow-up

Outcomes

Primary Outcome Measures

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

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

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.

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

Secondary Outcome Measures

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

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

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

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

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

Full Information

NCT ID

NCT04566497

First Posted

August 31, 2020

Last Updated

November 19, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04566497

Brief Title

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.

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 30, 2021 (Actual)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Percutaneous Coronary Intervention, Coronary Artery Bypass Grafting

Keywords

Stress testing, Myocardial ischemia, Coronary artery disease, coronary revascularization

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2664 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

no systematic stress testing during follow-up

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

systematic annual stress testing during follow-up

Intervention Type

Other

Intervention Name(s)

No stress testing

Other Intervention Name(s)

Arm1

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

stress testing

Other Intervention Name(s)

Arm 2

Intervention Description

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

Primary Outcome Measure Information:

Title

demonstrate the non-inferiority of a strategy of clinical follow-up

Description

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

Title

demonstrate the non-inferiority of a strategy of clinical follow-up

Description

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

Title

demonstrate the non-inferiority of a strategy of clinical follow-up

Description

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

Title

demonstrate the non-inferiority of a strategy of clinical follow-up

Description

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

Secondary Outcome Measure Information:

Title

compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

Description

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

Title

compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

Description

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

Title

compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

Description

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

Title

compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

Description

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

Title

compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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 Contemporaneous enrollment in a different clinical trial 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nadjib Hammoudi, MD PHD

Phone

01 42 16 55 35

Ext

+33

nadjib.hammoudi@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadjib Hammoudi, MD PHD

Organizational Affiliation

APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pitie salpetriere

City

Paris

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

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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.

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