Symptomatic Carotid Outcomes Registry
Running, not enrolling
Conditions studied: Carotid Stenosis, Ischemic Stroke, Transient Ischemic Attack
In brief
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%.
Key facts
- Study ID
- NCT05300737
- Run by
- University of Maryland, Baltimore
- People needed
- 114
- Starts
- 2022-08-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-10-20
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Retinal ischemia only (amaurosis fugax, branch retinal artery occlusion (BRAO), central retinal artery occlusion (CRAO)
- Female sex
- Most recent stroke or TIA >1 week ago
- Radiologic Reduced Stroke RISK:
- Transcranial Doppler (TCD) study demonstrating lack of microembolic signals
- Cross-sectional MRI plaque imaging demonstrating absence of intraplaque hemorrhage
- For patients with TIA: brain MRI shows no DWI lesion
You may not qualify if…
- 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
Where it is running
- Hartford Hospital — Hartford, Connecticut, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Rush Medical Center — Chicago, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Maryland Medical Center — Baltimore, Maryland, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- University of Massachusetts Medical Center — Worcester, Massachusetts, United States
- University of Rochester — Rochester, New York, United States
- Rhode Island Hospital — Providence, Rhode Island, United States
- Baylor Medicine — Houston, Texas, United States
- Calgary Health Sciences Center — Calgary, Alberta, Canada
- University of Alberta — Edmonton, Alberta, Canada
- Vancouver General Hospital — Vancouver, British Columbia, Canada
- University of Manitoba — Winnipeg, MN, Canada
- Northern Ontario School of Medicine — Greater Sudbury, Ontario, Canada
- Western University/London Health Sciences Center — London, Ontario, Canada
- CHUM — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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