Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis

Stroke Clinical Trial

— AMTEC  

Official title:

Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805311
• Other study ID #: NCT00805311
• Status: Terminated
• Phase: Phase 4
• First received: December 8, 2008
• Last updated: October 7, 2015
• Start date: April 2009
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: Russian Cardiology Research and Production Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Healthcare of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic
• Stroke

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Russian Cardiology Research and Production Center	Moscow
Russian Federation	Russian Cardiology Research and Production Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Cardiology Research and Production Center

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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 F — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death		5 years	Yes
Secondary	composite of nonfatal stroke, nonfatal MI, carotid/coronary revascularization and death		5 years	No