Due to the clear advantage of carotid endarterectomy
AMTEC
Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
Sponsor study identifier
interventional
400
1 country
2
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2008
Actual (reported)December 9, 2008
Actual (reported)April 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 2014
Actual (reported)May 2014
Actual (reported)composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
5 years
composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
5 years
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.
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.
CEA involves a neck incision and physical removal of the plaque from the inside of the artery
aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
atorvastatin, aspirin, losartan, amlodipine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordRussian Cardiology Research and Production Center
Moscow, 121552, Russia
Russian Cardiology Research and Production Center
Moscow, Russia
Kolos I, Troitskiy A, Balakhonova T, Shariya M, Skrypnik D, Tvorogova T, Deev A, Boytsov S; Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) Study Group. Modern medical treatment with or without carotid endarterectomy for severe asymptomatic carotid atherosclerosis. J Vasc Surg. 2015 Oct;62(4):914-22. doi: 10.1016/j.jvs.2015.05.005.
Kolos I, Loukianov M, Dupik N, Boytsov S, Deev A. Optimal medical treatment versus carotid endarterectomy: the rationale and design of the Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) study. Int J Stroke. 2015 Feb;10(2):269-74. doi: 10.1111/ijs.12019. Epub 2013 Mar 15.
Evgeniy Chazov, MD
Russian Cardiology Research and Production Center
400 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2008
First Posted
December 9, 2008
Study Start
April 2009
Date type not reportedThis date has not been verified as actual or estimated.
Relation of Carotid Artery Plaque Inflammation, Covert Stroke and White Matter Disease
Linked from the registry description. Each source intervention is retained as reported.
In: atorvastatin, aspirin, losartan, amlodipine
In: atorvastatin, aspirin, losartan, amlodipine
In: atorvastatin, aspirin, losartan, amlodipine
In: atorvastatin, aspirin, losartan, amlodipine
Contact the study team to confirm eligibility.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
October 12, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: