Study Stopped
Due to the clear advantage of carotid endarterectomy
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
AMTEC
Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
1 other identifier
interventional
400
1 country
2
Brief Summary
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2009
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2008
CompletedFirst Posted
Study publicly available on registry
December 9, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedOctober 12, 2015
October 1, 2015
5.1 years
December 8, 2008
October 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
5 years
Secondary Outcomes (1)
composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
5 years
Study Arms (2)
CEA Group
EXPERIMENTALPatients 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.
OMT Group
ACTIVE COMPARATORPatients 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Russian Cardiology Research and Production Center
Moscow, 121552, Russia
Russian Cardiology Research and Production Center
Moscow, Russia
Related Publications (2)
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.
PMID: 26410046BACKGROUNDKolos 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.
PMID: 23490405RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Evgeniy Chazov, MD
Russian Cardiology Research and Production Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
December 8, 2008
First Posted
December 9, 2008
Study Start
April 1, 2009
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
October 12, 2015
Record last verified: 2015-10