Clinical Trial: " Endarterectomy Combined With Optimal Medical Therapy (OMT) vs OMT Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: " Endarterectomy Combined With Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis
Brief Summary: 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.
Detailed Summary:
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:
- Any ipsilateral stroke within 6 years after randomization or procedural (within 30 days after revascularization) stroke or death
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Any stroke or procedural death [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Any stroke within 6 years after randomization or procedural death (within 30 days after revascularization)
- Any disabling or fatal stroke or procedural death [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Any disabling or fatal stroke within 6 years after randomization or procedural death (within 30 days after revascularization)
- Any stroke or TIA or procedural death [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Any stroke or TIA within 6 years after randomization or procedural death within 6 years after randomization
- Any stroke or death [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Any stroke or death within 6 years after randomization
- Myocardial infarction [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Myocardial infarction within 6 years after randomization
- Any death [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Any death within 6 years after randomization
- Cardiovascular death [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Cardiovascular death within 6 years after randomization
- Any hospitalisation for vascular disease [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Any hospitalisation for vascular disease within 6 years after randomization
- Cranial nerve palsy attributed to revascularisation [ Time Frame: M1 ]Cranial nerve palsy attributed to revascularisation within 30 days after revascularization
- Haematoma caused by treatment requiring surgery, transfusion or prolonging hospital stay [ Time Frame: M1 ]Haematoma caused by treatment requiring surgery, transfusion or prolonging hospital stay within 30 days after revascularization
- 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 ]Further revascularisation of the randomised artery after the initial attempt.
- Carotid revascularisation [ Time Frame: M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72 ]Carotid revascularisation during follow-up other than that allocated at randomisation
- New cerebral infarction or haemorrhage [ Time Frame: M24 ]New cerebral infarction or haemorrhage on MRI at 2 years
- Increase in white-matter changes [ Time Frame: M0, M24 ]Increase in white-matter changes on MRI at 2 years.
- Cognitive impairment [ Time Frame: M0, M24 ]Cognitive impairment assessed by the Montreal Cognitive Assessment (MoCA) with adjustment for demographic factors.
- Depression [ Time Frame: M0, M24 ]Depression measured by the Centre for Epidemiologic Studies Depression (CES-D) Scale.
- Health-related quality of life [ Time Frame: M0, M24 ]Health-related quality of life measured using the European Quality Of Life (EQ-5D).
- Disability [ Time Frame: M0, M24 ]Disability measured by the modified Rankin scale with structured interview
- 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 ]Achievement of goals for each of the components of optimal medical treatment
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier St Anne
Dates:
Date Received: July 19, 2016
Date Started: September 2016
Date Completion: December 2022
Last Updated: September 27, 2016
Last Verified: July 2016
