" 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 "

NCT02841098 | Completed

• 1 other identifier: D15-P010
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 23

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.

Conditions

Asymptomatic Carotid Artery Stenosis

Keywords

Carotid stenosis,stroke,endarterectomy,medical therapy

Outcome Measures

Primary Outcomes (1)

• 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

  M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

Secondary Outcomes (19)

• Any stroke or procedural death

  M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

• Any disabling or fatal stroke or procedural death

  M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

• Any stroke or TIA or procedural death

  M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

• Any stroke or death

  M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

• Myocardial infarction

  M1, M6, M12, M18, M24, M30, M36, M42, M48, M54, M60, M66, M72

Study Arms (2)

Carotid endarterectomy combined with optimal medical therapy

EXPERIMENTAL

Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)

Other: Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)

Optimal medical therapy (OMT)

ACTIVE COMPARATOR

Optimal medical therapy (OMT)

Drug: Optimal medical therapy alone

Interventions

Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) OTHER

Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) (Surgery and Drug)

Carotid endarterectomy combined with optimal medical therapy

Optimal medical therapy alone DRUG

Optimal medical therapy alone

Optimal medical therapy (OMT)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years or over
• No ipsilateral stroke or TIA within 180 days of randomization
• Atherosclerotic carotid stenosis between 70 and 99% (NASCET method)
• At least one of the following markers of ipsilateral stroke risk:
• Silent brain infarction on MRI, DWi, consistent with embolism from or hemodynamic consequences of the qualifyiing stenosis
• History of contralateral TIA or ischemic stroke due to atherosclerotic carotid disease
• Predominantly echolucent plaque on ultrasound
• Rapid (within 1 year) carotid stenosis progresion
• TCD-detected microembolic signals
• Impairment of TCD-measured cerebral vasomotor reserve
• Intraplaque haemorrhage on magnetic resonance imaging
• Rapid and severe stenosis progression
• Patient is able and willing to give informed consent

You may not qualify if:

• Previous revascularization procedure in the artery to be randomised
• Patients not suitable for endarterectomy due to anatomical factors
• Carotid stenosis caused by non-atherosclerotic disease e.g. neck radiotherapy or fibromuscular disease
• Patients who have had contralateral carotid artery or vertebral artery or intracranial artery revascularisation within 6 weeks prior to randomisation
• Patients with planned revascularisation of the contralateral carotid artery or a vertebral artery or an intracranial artery within 6 weeks after randomisation or the date of CEA
• Patients who have had coronary artery bypass grafting within 3 months prior to randomisation or other major surgery within 6 weeks prior to randomisation
• Patients with planned coronary artery bypass grafting or other major surgery within 6 weeks after CEA of the artery considered for treatment in the trial
• Patients with pre-existing disability (modified Rankin score greater than 2)
• Patients who have a low 5-year life expectancy (see appendix for definition)
• Patients intolerant or allergic to all of the medications available for OMT
• Patients in clinical trials of investigational medicinal products or who have been in clinical trials within the last 4 months will not be enrolled unless otherwise agreed
• Patients who are known to be pregnant
• Patients unwilling or unable to participate in follow-up

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Hôpitaux Universitaires Paris Ile-de-Franc Ouest: collaborator

Study Sites (23)

Centre Hospitalier régional de Besançon, Hôpital Jean Minjoz

Besançon, 25030, France

Location

CHU Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

CHRU La Cavale Blanche

Brest, 29200, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHU Dijon-Bourgogne

Dijon, 21079, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hôpital Mignot - CH Versailles

Le Chesnay, 78150, France

Location

CHRU de Lille

Lille, 59037, France

Location

Hôpital Neurologique Pierre Wertheimer GHE

Lyon, 69677, France

Location

Hôpital Gui de Chauliac

Montpellier, 34 295, France

Location

CHU de Nice, Hôpital Pasteur 2

Nice, 06000, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75013, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Centre Hospitalier Bichat-Claude Bernard

Paris, 75018, France

Location

CHU La Milétrie

Poitiers, 86021, France

Location

Hôpital Pontchaillou CHU Rennes

Rennes, 35033, France

Location

CHU de Rouen, Hôpital Charles Nicolle

Rouen, 76031, France

Location

Hôpital Nord CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

CHU de Strasbourg, Hôpital de Hautpierre

Strasbourg, 67098, France

Location

CHU de Toulouse Hôpital Pierre-Paul Riquet

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jean-Louis MAS

  CHSA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 22, 2016
• Study Start: September 16, 2019
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

FR (23)