intensive medical therapy: Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification
Study summary
The purpose of this study is to build upon trials done over 30 years ago, which did not include statins, new antiplatelet agents, and newer antihypertensive medications. Since the landmark trials (NASCET, ECST), there have been new developments in medical stroke prevention, which creates a gap in knowledge. The aim of this study is to evaluate that clinical care with Intensive Medical Therapy (IMT) alone, the one year stroke rate in patients with symptomatic carotid stenosis and low risk clinical features will be \<5%.
Eligibility
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥40 years plus stroke or TIA ipsilateral to 50-99% ICA stenosis
In addition, patients must have at least one clinical or radiologic marker of reduced stroke risk
Clinical Reduced Stroke RISK:
1. Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
2. Female sex
3. Most recent stroke or TIA \>1 week ago
Radiologic Reduced Stroke RISK:
1. Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
2. Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
3. For patients with TIA: brain MRI shows no DWI lesion
Exclusion Criteria:
Atrial fibrillation or other high-risk sources of cardiac embolism unless it is device detected AF only or duration \<6 minutes
Alcohol and substance abuse within the prior 24 months
Clinically significant bleeding diathesis (platelet count \<100K, prothrombin time \>14 seconds)
Clear indication for therapeutic anticoagulation (for example, DVT or pulmonary embolism within past 3 months)
Left ventricular ejection fraction \<20%
Known allergy or intolerance to aspirin or clopidogrel
Life expectancy less than 12 months
Moderate/severe dementia (Mini-mental or MOCA score \<22
Modified Rankin score of \>4
Nonatherosclerotic cause of carotid stenosis
Most recent symptomatic event \>180 days from the time of enrollment
\-
Primary outcome measure(s)
Ischemic stroke — within 12 months ipsilateral to carotid stenosis, with radiologic confirmation
Trial sites (18)
Facility
City
Region
Status
Hartford Hospital
Hartford
Connecticut
Emory University Hospital
Atlanta
Georgia
Northwestern Memorial Hospital
Chicago
Illinois
Rush Medical Center
Chicago
Illinois
University of Iowa
Iowa City
Iowa
University of Maryland Medical Center
Baltimore
Maryland
Baystate Medical Center
Springfield
Massachusetts
University of Massachusetts Medical Center
Worcester
Massachusetts
University of Rochester
Rochester
New York
Rhode Island Hospital
Providence
Rhode Island
Baylor Medicine
Houston
Texas
Calgary Health Sciences Center
Calgary
Alberta
University of Alberta
Edmonton
Alberta
Vancouver General Hospital
Vancouver
British Columbia
University of Manitoba
Winnipeg
MN
Northern Ontario School of Medicine
Greater Sudbury
Ontario
Western University/London Health Sciences Center
London
Ontario
CHUM
Montreal
Quebec
More University of Maryland, Baltimore trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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