Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (NCT00805311) | Clinical Trial Compass
TerminatedPhase 4
Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis
Stopped: Due to the clear advantage of carotid endarterectomy
Russia400 participantsStarted 2009-04
Plain-language summary
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
Who can participate
Age range40 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
composite of nonfatal stroke, nonfatal composite of nonfatal stroke, nonfatal myocardial infarction and death
Timeframe: 5 years
Trial details
NCT IDNCT00805311
SponsorRussian Cardiology Research and Production Center