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Clinical Trials in Canada / NCT05300737
Active, not recruiting Observational

Symptomatic Carotid Outcomes Registry

NCT05300737 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2022-08-01
Last updated
2025-10-20

Condition(s) studied

Carotid StenosisIschemic StrokeTransient Ischemic Attack

Investigational drug(s) / intervention(s)

intensive medical therapy

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)

Trial sites (18)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05300737 on ClinicalTrials.gov ↗ ← All trials in Canada