Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC)
This study has been terminated.
(Due to the clear advantage of carotid endarterectomy)
Sponsor:
Russian Cardiology Research and Production Center
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
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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
Atorvastatin calcium
U.S. FDA Resources
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
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:
|
Atherosclerosis Carotid Stenosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases Amlodipine Atorvastatin Losartan Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Anti-Arrhythmia Agents Anticholesteremic Agents Antihypertensive Agents Antimetabolites Calcium Channel Blockers Cardiovascular Agents Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015