Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis - Full Text View

Sponsored by:	Russian Cardiology Research and Production Center
Information provided by:	Russian Cardiology Research and Production Center
ClinicalTrials.gov Identifier:	NCT00805311

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 IV

Drug Information available for: Acetylsalicylic acid Amlodipine Amlodipine besylate Losartan Losartan potassium Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis.

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: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Restenosis after CEA [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	February 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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.	Procedure: Carotid Endarterectomy CEA involves a neck incision and physical removal of the plaque from the inside of the artery

Arms

Assigned Interventions

1: Experimental

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

2: Active Comparator

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.

Procedure: Carotid Endarterectomy

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

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 (eg, 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
Moscow, Russian Federation, 121552

Sponsors and Collaborators

Russian Cardiology Research and Production Center

Investigators

Study Chair:

Evgeniy Chazov, MD

Russian Cardiology Research and Production Center

More Information

No publications provided

Responsible Party:	KRKA ( Anna Zakharova )
Study ID Numbers:	NCT00805311
Study First Received:	December 8, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00805311 History of Changes
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Russian Cardiology Research and Production Center:

Internal Carotid Artery Stenosis
Carotid Endarterectomy
Stroke
Cerebrovascular
Atherosclerosis

Study placed in the following topic categories:

Antimetabolites
Atherosclerosis
Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Vasodilator Agents
Cerebral Infarction
Calcium Channel Blockers
Constriction, Pathologic
Fibrinolytic Agents
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Fibrin Modulating Agents
Aspirin
Anti-Inflammatory Agents, Non-Steroidal

Anti-Arrhythmia Agents
Analgesics
Aggression
Arterial Occlusive Diseases
Losartan
Antilipemic Agents
Cyclooxygenase Inhibitors
Stroke
Vascular Diseases
Central Nervous System Diseases
Anticholesteremic Agents
Cardiovascular Agents
Angiotensin II
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Atherosclerosis
Pathological Conditions, Anatomical
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Fibrinolytic Agents
Constriction, Pathologic
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Membrane Transport Modulators

Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Arrhythmia Agents
Analgesics
Arterial Occlusive Diseases
Losartan
Antilipemic Agents
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009