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

This study has been terminated.
(Due to the clear advantage of carotid endarterectomy)
Sponsor:
Information provided by (Responsible Party):
Igor Kolos, Russian Cardiology Research and Production Center
ClinicalTrials.gov Identifier:
NCT00805311
First received: December 8, 2008
Last updated: June 10, 2014
Last verified: June 2014
  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:


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

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
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:
Responsible Party: Igor Kolos, Senior Researcher, Russian Cardiology Research and Production Center
ClinicalTrials.gov Identifier: NCT00805311     History of Changes
Other Study ID Numbers: NCT00805311
Study First Received: December 8, 2008
Last Updated: June 10, 2014
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:
Carotid Stenosis
Carotid Artery Diseases
Atherosclerosis
Arteriosclerosis
Constriction, Pathologic
Stroke
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical
Aspirin
Amlodipine
Losartan
Atorvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on August 26, 2014