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 calcium

U.S. FDA Resources

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

Primary Outcome Measures:

Major adverse cardiovascular events (MACE: composite of stroke, myocardial infarction and cardiovascular death) and any death [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Restenosis after CEA [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Patients 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. Additionally patients will undergo CEA.	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: 2 Patients 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.	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: 1

Patients 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. Additionally patients will undergo CEA.

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: 2

Patients 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.

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
Allergy or contraindications to study medications (statins, ASA, losartan, amlodipine)

Contacts and Locations

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

Contacts

Contact: Igor Kolos, PhD	414-6201 ext +7(495)	docsn173@yandex.ru
Contact: Sergey Boytsov, MD	149-0141 ext +7(499)	prof-boytsov@mail.ru

Locations

Russian Federation
Russian Cardiology Research and Production Center	Recruiting
Moscow, Russian Federation, 121552
Contact: Igor Kolos, PhD 414-6201 ext +7(495) docsn173@yandex.ru
Contact: Sergey Boytsov, MD 149-0141 ext +7(499) prof-boytsov@mail.ru
Principal Investigator: Evgeniy Chazov, MD
Russian Cardiology Research and Production Center	Recruiting
Moscow, Russian Federation
Contact: Igor Kolos, PhD (495)414-6201 ext +7 docsn173@yandex.ru
Contact: Nikolay Dupik dnv-74@yandex.ru
Principal Investigator: Sergey Boytsov, MD

Sponsors and Collaborators

Russian Cardiology Research and Production Center

Krka, d.d., Novo mesto, Slovenia

Investigators

Study Chair:

Evgeniy Chazov, MD

Russian Cardiology Research and Production Center

More Information

No publications provided

Responsible Party:	Anna Zakharova, KRKA d.d. Novo mesto, Slovenia
ClinicalTrials.gov Identifier:	NCT00805311 History of Changes
Other Study ID Numbers:	NCT00805311
Study First Received:	December 8, 2008
Last Updated:	June 14, 2011
Health Authority:	Russia: Ministry of Health 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
Atherosclerosis
Constriction, Pathologic
Stroke
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Carotid Artery 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 May 19, 2013

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