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Sponsored by: |
Russian Cardiology Research and Production Center |
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Information provided by: | Russian Cardiology Research and Production Center |
ClinicalTrials.gov Identifier: | NCT00805311 |
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
Condition | Intervention | Phase |
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Carotid Artery Stenosis Atherosclerosis Stroke |
Procedure: Carotid Endarterectomy Drug: atorvastatin, aspirin, losartan, amlodipine |
Phase IV |
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. |
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 |
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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
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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.
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Procedure: Carotid Endarterectomy
CEA involves a neck incision and physical removal of the plaque from the inside of the artery
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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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Russian Federation | |
Russian Cardiology Research and Production Center | |
Moscow, Russian Federation, 121552 |
Study Chair: | Evgeniy Chazov, MD | Russian Cardiology Research and Production Center |
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 |
Internal Carotid Artery Stenosis Carotid Endarterectomy Stroke Cerebrovascular Atherosclerosis |
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 |
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 |