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Active, Not Recruiting

NCT Number: NCT05300737

Symptomatic Carotid Outcomes Registry

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%.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Calgary Health Sciences Center, Calgary, Alberta, Canada

Loading trial locations.

About this study

This study will only be evaluating clinical care and no interventions will be done specifically for this research.

  • Informed consent from patient or legally authorized representative.
  • Participant survey/questionnaire completion at baseline, 6 and 12 months after enrollment
  • All data collected will be entered into a secure research data registry created for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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

-

Treatment and study plan

intensive medical therapy

Other

Dual antiplatelet therapy, high potency statins, HTN control, lifestyle modification

Primary outcomes

  1. Ischemic stroke

    Time frame: within 12 months

    ipsilateral to carotid stenosis, with radiologic confirmation

Secondary outcomes

  1. Myocardial infarction

    Time frame: within 12 months

    ECG will be performed for suspected myocardial infarction and will be diagnosed if appropriate ST changes and confirmation with troponin measurements

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Symptomatic Carotid Outcomes Registry With Multi-center Evaluation

Acronym: SCORE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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