An interventional study of Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) and Optimal medical therapy alone in Asymptomatic Carotid Artery Stenosis, sponsored by Centre Hospitalier St Anne. Completed at 23 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Prevention
The purpose of this study is to determine whether carotid surgery combined with optimal medical therapy improves long-term survival free of ipsilateral stroke in patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared with optimal medical therapy alone.
Carotid artery stenosis >= 50% affects about 3% of subjects >= 60 years and accounts for up to 15% of all ischemic strokes. Overall, patients with asymptomatic carotid stenosis have a low risk of ipsilateral stroke on modern medical therapy. It is therefore uncertain whether the benefit of carotid surgery still justifies the perioperative risk of stroke or death, and whether revascularisation is good value for money considering competing demands on health services. Several imaging techniques have been developed to identify patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke. Specifically, the presence of transcranial Doppler (TCD)-detected embolic signals, intraplaque haemorrhage on magnetic resonance imaging, TCD-measured impaired cerebral vasomotor reserve or rapid stenosis progression have all been shown to involve an at least 3-fold higher risk of ipsilateral stroke. However, before recommendations for clinical practice can be made regarding the use of these tools, their utility must be demonstrated in a formal randomised clinical trial. Our hypothesis is that the use of these predictors can identify a subset of patients with asymptomatic carotid stenosis who could benefit from prophylactic endarterectomy.
Carotid endarterectomy The procedure will be carried out with the technique routinely used by each surgeon. Operative reports and perioperative complications will be collected. CEA will have to be performed as soon as possible, within 60 days after randomization.
Optimal medical therapy OMT will be applied to all patients and started immediately after randomisation.
OMT will be defined by the adhoc committee and follow relevant guidelines. It will include:
OMT may be modified during the course of the trial to take account revised guidelines or new evidence.
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's enrollment of 43 is below the median of 106 across 182 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Centre Hospitalier St Anne is the lead sponsor of 99 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least one of the following markers of ipsilateral stroke risk:
Exclusion Criteria:
Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)
Other: Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)
Optimal medical therapy (OMT)
Drug: Optimal medical therapy alone
Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) (Surgery and Drug)
Optimal medical therapy alone
Ipsilateral stroke or procedural stroke or death
Any ipsilateral stroke within 6 years after randomization or procedural (within 30 days after revascularization) stroke or death
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any stroke or procedural death
Any stroke within 6 years after randomization or procedural death (within 30 days after revascularization)
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any disabling or fatal stroke or procedural death
Any disabling or fatal stroke within 6 years after randomization or procedural death (within 30 days after revascularization)
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any stroke or TIA or procedural death
Any stroke or TIA within 6 years after randomization or procedural death within 6 years after randomization
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any stroke or death
Any stroke or death within 6 years after randomization
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Myocardial infarction
Myocardial infarction within 6 years after randomization
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any death
Any death within 6 years after randomization
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Cardiovascular death
Cardiovascular death within 6 years after randomization
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Any hospitalisation for vascular disease
Any hospitalisation for vascular disease within 6 years after randomization
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Cranial nerve palsy attributed to revascularisation
Cranial nerve palsy attributed to revascularisation within 30 days after revascularization
Time frame: M1
Haematoma caused by treatment requiring surgery, transfusion or prolonging hospital stay
Haematoma caused by treatment requiring surgery, transfusion or prolonging hospital stay within 30 days after revascularization
Time frame: M1
Further revascularisation of the randomised artery after the initial attempt.
Further revascularisation of the randomised artery after the initial attempt.
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Carotid revascularisation
Carotid revascularisation during follow-up other than that allocated at randomisation
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
New cerebral infarction or haemorrhage
New cerebral infarction or haemorrhage on MRI at 2 years
Time frame: M24
Increase in white-matter changes
Increase in white-matter changes on MRI at 2 years.
Time frame: M0, M24
Cognitive impairment
Cognitive impairment assessed by the Montreal Cognitive Assessment (MoCA) with adjustment for demographic factors.
Time frame: M0, M24
Depression
Depression measured by the Centre for Epidemiologic Studies Depression (CES-D) Scale.
Time frame: M0, M24
Health-related quality of life
Health-related quality of life measured using the European Quality Of Life (EQ-5D).
Time frame: M0, M24
Disability
Disability measured by the modified Rankin scale with structured interview
Time frame: M0, M24
Achievement of goals for each of the components of optimal medical treatment
Achievement of goals for each of the components of optimal medical treatment
Time frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72
Plan to share: Undecided
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier St Anne