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

Primary Purpose

Carotid Artery Stenosis, Atherosclerosis, Stroke

Status
Terminated
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Carotid Endarterectomy
atorvastatin, aspirin, losartan, amlodipine
Sponsored by
Russian Cardiology Research and Production Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Artery Stenosis focused on measuring Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Russian Cardiology Research and Production Center
  • Russian Cardiology Research and Production Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CEA Group

OMT Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death

Secondary Outcome Measures

composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death

Full Information

First Posted
December 8, 2008
Last Updated
October 7, 2015
Sponsor
Russian Cardiology Research and Production Center
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1. Study Identification

Unique Protocol Identification Number
NCT00805311
Brief Title
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
Acronym
AMTEC
Official Title
Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to the clear advantage of carotid endarterectomy
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Cardiology Research and Production Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis, Atherosclerosis, Stroke
Keywords
Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CEA Group
Arm Type
Experimental
Arm Description
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.
Arm Title
OMT Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Carotid Endarterectomy
Intervention Description
CEA involves a neck incision and physical removal of the plaque from the inside of the artery
Intervention Type
Drug
Intervention Name(s)
atorvastatin, aspirin, losartan, amlodipine
Intervention Description
aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
Primary Outcome Measure Information:
Title
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
Time Frame
5 years
Secondary Outcome Measure Information:
Title
composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeniy Chazov, MD
Organizational Affiliation
Russian Cardiology Research and Production Center
Official's Role
Study Chair
Facility Information:
Facility Name
Russian Cardiology Research and Production Center
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Russian Cardiology Research and Production Center
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
26410046
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.
Results Reference
background
PubMed Identifier
23490405
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.
Results Reference
result

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Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis

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