Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis - Full Text View

Purpose

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

Condition	Intervention	Phase
Carotid Artery Stenosis Atherosclerosis Stroke	Procedure: Carotid Endarterectomy Drug: atorvastatin, aspirin, losartan, amlodipine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Aspirin Amlodipine Amlodipine besylate Losartan Losartan potassium Atorvastatin Atorvastatin calcium Atorvastatin calcium trihydrate

U.S. FDA Resources

Further study details as provided by Russian Cardiology Research and Production Center:

Primary Outcome Measures:

composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death [ Time Frame: 5 years ] [ Designated as safety issue: No ]


Enrollment:	400
Study Start Date:	April 2009
Study Completion Date:	May 2014
Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CEA Group Patients will undergo carotid endarterectomy (CEA) and receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.	Procedure: Carotid Endarterectomy CEA involves a neck incision and physical removal of the plaque from the inside of the artery Drug: atorvastatin, aspirin, losartan, amlodipine aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
Active Comparator: OMT Group Patients will receive conservative therapy - optimal medical treatment (OMT) including statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.	Drug: atorvastatin, aspirin, losartan, amlodipine aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day

Arms

Assigned Interventions

Experimental: CEA Group

Patients will undergo carotid endarterectomy (CEA) and receive medical treatment including medical therapy with statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.

Procedure: Carotid Endarterectomy

CEA involves a neck incision and physical removal of the plaque from the inside of the artery

Drug: atorvastatin, aspirin, losartan, amlodipine

aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day

Active Comparator: OMT Group

Patients will receive conservative therapy - optimal medical treatment (OMT) including statins (at least 10 mg atorvastatin irrespective of the baseline cholesterol level), aspirin (100 mg daily) and antihypertensive therapy (at least 50 mg losartan and 5 mg amlodipine 75 mg daily irrespective of the baseline arterial pressure level). Further conservative medical treatment includes modification of cardiovascular risk factors according to current recommendations.

Drug: atorvastatin, aspirin, losartan, amlodipine

aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day

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


Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805311

Locations


Russian Federation
Russian Cardiology Research and Production Center
Moscow, Russian Federation, 121552
Russian Cardiology Research and Production Center
Moscow, Russian Federation

Sponsors and Collaborators

Russian Cardiology Research and Production Center

Investigators


Study Chair:	Evgeniy Chazov, MD	Russian Cardiology Research and Production Center

More Information

Publications:

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.

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.


Responsible Party:	Igor Kolos, Senior Researcher, Russian Cardiology Research and Production Center
ClinicalTrials.gov Identifier:	NCT00805311 History of Changes
Study First Received:	December 8, 2008
Last Updated:	October 7, 2015
Health Authority:	Russia: Ministry of Healthcare of the Russian Federation

Keywords provided by Russian Cardiology Research and Production Center:


Internal Carotid Artery Stenosis Carotid Endarterectomy Stroke Cerebrovascular Atherosclerosis

Additional relevant MeSH terms:


Constriction, Pathologic Atherosclerosis Carotid Stenosis Pathological Conditions, Anatomical Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Aspirin Atorvastatin Calcium	Amlodipine Losartan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016