Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis "AMTEC"

Terminated

Phase 4 Results N/A

Update History

12 Jun '14
The eligibility criteria were updated.
New
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)
Old
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 - Allergy or contraindications to study medications (statins, ASA, losartan, amlodipine)
A location was updated in Moscow.
New
The overall status was removed for Russian Cardiology Research and Production Center.
A location was updated in Moscow.
New
The overall status was removed for Russian Cardiology Research and Production Center.