Clinical trial NCT00805311: Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
Official title: Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Carotid Artery Stenosis
Atherosclerosis
Stroke
Keywords: Internal Carotid Artery Stenosis
Carotid Endarterectomy
Stroke
Cerebrovascular
Atherosclerosis
Lead sponsor: Russian Cardiology Research and Production Center
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.

Detailed description: It is well known that risk of fatal and non-fatal stroke is increased in patients with significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or death is less than 3%.

Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60% to 79%, the AHA guidelines indicate that some physicians delay revascularization until there is greater than 80% stenosis in asymptomatic patients.

Our study is designed to determine whether optimal medical therapy alone reduces the risk of death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA coupled with optimal medical therapy.

Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral carotid artery stenosis that was considered to be severe (carotid artery diameter reduction 70%-79% on ultrasound)
* This stenosis had not caused any stroke, transient cerebral ischaemia, or other relevant neurological symptoms in the past 6 months
* Both doctor and patient were substantially uncertain whether to choose immediate CEA, or deferral of any CEA until a more definite need for it was thought to have arisen
* The patient had no known circumstance or condition likely to preclude long-term follow-up
* Neurologist's explicit consent to potentially perform CEA

Exclusion Criteria:

* Previous ipsilateral CEA
* Expectation of poor surgical risk (e.g., because of recent acute myocardial infarction)
* Some probable cardiac source of emboli (because the main stroke risk might then be from cardiac, not carotid, emboli)
* Inability to provide informed consent
* Underlying disease other than atherosclerosis (inflammatory or autoimmune disease)
* Life expectancy \< 6 months
* Advanced dementia
* Advanced renal failure (serum creatinine \> 2.5 mg/dL)
* Unstable severe cardiovascular comorbidities (e.g., unstable angina, heart failure)
* Restenosis after prior CAS or CEA
* Atrial fibrillation
* Allergy or contraindications to study medications (statins, ASA, losartan, amlodipine)

Primary outcomes:
measure: composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
timeFrame: 5 years
Secondary outcomes:
measure: composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
timeFrame: 5 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian Cardiology Research and Production Center
city: Moscow
country: Russian Federation
facility: Russian Cardiology Research and Production Center
Study officials:
affiliation: Russian Cardiology Research and Production Center
name: Evgeniy Chazov, MD
role: STUDY_CHAIR
References:
citation: Kolos I, Troitskiy A, Balakhonova T, Shariya M, Skrypnik D, Tvorogova T, Deev A, Boytsov S; Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) Study Group. Modern medical treatment with or without carotid endarterectomy for severe asymptomatic carotid atherosclerosis. J Vasc Surg. 2015 Oct;62(4):914-22. doi: 10.1016/j.jvs.2015.05.005.
citation: Kolos I, Loukianov M, Dupik N, Boytsov S, Deev A. Optimal medical treatment versus carotid endarterectomy: the rationale and design of the Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) study. Int J Stroke. 2015 Feb;10(2):269-74. doi: 10.1111/ijs.12019. Epub 2013 Mar 15.