Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Russian Cardiology Research and Production Center
• Treatments: Amlodipine; Aspirin; Atorvastatin; Atorvastatin Calcium; Losartan

Criteria

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)