Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC)

October 7, 2015 updated by: Igor Kolos, Russian Cardiology Research and Production Center

Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Russian Cardiology Research and Production Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT00805311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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