Status:
TERMINATED
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
Lead Sponsor:
Russian Cardiology Research and Production Center
Conditions:
Carotid Artery Stenosis
Atherosclerosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00805311
Start Date
April 1 2009
End Date
May 1 2014
Last Update
October 12 2015
Active Locations (2)
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1
Russian Cardiology Research and Production Center
Moscow, Russia, 121552
2
Russian Cardiology Research and Production Center
Moscow, Russia