Carotid Artery StenosisPhase 4AMTECNCT00805311
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
A Phase 4 study testing Carotid Endarterectomy and atorvastatin, aspirin, losartan, amlodipine in people with Carotid Artery Stenosis and Atherosclerosis, run by Russian Cardiology Research and Production Center at 2 sites in Russia.
Trial summary
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis, Atherosclerosis, Stroke
- What is being tested?
- Carotid Endarterectomy and atorvastatin, aspirin, losartan, amlodipine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesRussia
- Study dates
- Apr 2009to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Russian Cardiology Research and Production Center
Moscow, 121552
Russian Cardiology Research and Production Center
Moscow
About this study
Official title: Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
Read the 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.
- Conditions
- Carotid Artery Stenosis, Atherosclerosis, Stroke
- Being tested
- Carotid Endarterectomy, atorvastatin, aspirin, losartan, amlodipine
- Keywords
- Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis
- Medical subject headings
- Carotid Stenosis, Atherosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid EndarterectomyProcedure or surgery
CEA involves a neck incision and physical removal of the plaque from the inside of the artery
atorvastatin, aspirin, losartan, amlodipineDrug
aspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day
| Study group | Role | What they receive |
|---|---|---|
| CEA Group | Experimental | 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. Receives: Procedure: Carotid Endarterectomy; Drug: atorvastatin, aspirin, losartan, amlodipine |
| OMT Group | Active comparator | 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. Receives: Drug: atorvastatin, aspirin, losartan, amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
Measured: 5 years
Secondary outcomes (1)
composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Due to the clear advantage of carotid endarterectomy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Cardiology Research and Production Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Kolos, Russian Cardiology Research and Production Center
- Investigators
- Evgeniy Chazov, MD, Study chair, Russian Cardiology Research and Production Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805311
- Sponsor's protocol ID
- NCT00805311
- Acronym
- AMTEC
- Status last verified
- Oct 2015
- First submitted
- 8 Dec 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26410046Kolos 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.
PubMed 23490405
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT00805311
- Acronym / sponsor ID
- AMTEC / NCT00805311
- Conditions
- Carotid Artery Stenosis, Atherosclerosis, Stroke
- Keywords
- Internal Carotid Artery Stenosis, Carotid Endarterectomy, Stroke, Cerebrovascular, Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the clear advantage of carotid endarterectomy
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Russian Cardiology Research and Production CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEA Group | Experimental | Procedure: Carotid Endarterectomy, Drug: atorvastatin, aspirin, losartan, amlodipinePatients 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 comparator | Drug: atorvastatin, aspirin, losartan, amlodipinePatients 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid EndarterectomyCEA involves a neck incision and physical removal of the plaque from the inside of the artery | Procedure or surgery | CEA Group |
| atorvastatin, aspirin, losartan, amlodipineaspirin 100 mg/day, atorvastatin 10 mg/day, losartan 50 mg/day, amlodipine 5 mg/day | Drug | CEA Group, OMT Group |
Primary outcome
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
Time frame: 5 years
1 secondary outcome
composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Due to the clear advantage of carotid endarterectomy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Background: PubMed 26410046Kolos 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.
- Results publication: PubMed 23490405Kolos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeniy Chazov, MD study chair
Russian Cardiology Research and Production Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carotid Endarterectomy and atorvastatin, aspirin, losartan, amlodipine in people with Carotid Artery Stenosis and Atherosclerosis, run by Russian Cardiology Research and Production Center at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to the clear advantage of carotid endarterectomy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805311, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015; AzTrials last refreshed its copy on 8 Nov 2026.