Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis

NCT ID: NCT00805311

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-05-31

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.

Conditions

Carotid Artery Stenosis; Atherosclerosis; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Carotid Endarterectomy

Intervention Type: PROCEDURE

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

atorvastatin, aspirin, losartan, amlodipine

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

atorvastatin, aspirin, losartan, amlodipine

Intervention Type: DRUG

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

Interventions

Carotid Endarterectomy

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

Intervention Type: PROCEDURE

atorvastatin, aspirin, losartan, amlodipine

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Russian Cardiology Research and Production Center

OTHER

Sponsor Role: lead

Responsible Party

Igor Kolos

Senior Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evgeniy Chazov, MD

Role: STUDY_CHAIR

Russian Cardiology Research and Production Center

Locations

Russian Cardiology Research and Production Center

Moscow, , Russia

Russian Cardiology Research and Production Center

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 26410046 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23490405 (View on PubMed)

Other Identifiers

NCT00805311

Identifier Type: -

Identifier Source: org_study_id