Medical Therapy vs Endovascular Intervention for Stroke
(NIA-SCORE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid Hasan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: David Hasan

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA) causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke and a 5%-8% risk per year for ipsilateral ischemic stroke during the first 2 years after ICA occlusion. Internal carotid artery occlusion causes an estimated 61,000 first-ever strokes per year in the US an incidence more than twice the annual occurrence of ruptured intracranial aneurysms Additionally, 40% of subjects with COICA who present with transient ischemic attack (TIA) and 70% of COICA who present with stroke have cognitive decline with increased risk of vascular dementia and Alzheimer's' disease (AD) with time (2,3). Symptomatic COICA subjects are at increased risk of developing cognitive impairment and progressive development of vascular dementia and AD with time. Our proposal leverages several compelling retrospective and prospective preliminary data from human to perform this exploratory trial with go/no-go criteria to proceed to a phase 3 based on the data generated

Research Team

David Hasan, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 21 with complete blockage of the neck's main artery due to plaque buildup, confirmed by imaging tests. They should have had a stroke or mini-stroke and show signs of slower blood flow in the brain. Participants must also struggle with certain cognitive tasks and not respond well to standard medication.

Inclusion Criteria

Baseline MoCA assessed by the neurosurgery team or neuropsychology team

Class A and B on COICA Classification

My blockage is caused by hardening of the arteries.

See 7 more

Exclusion Criteria

You have a blockage in two or more blood vessels.

Pregnant or risk of becoming pregnant

I have a severe illness like advanced kidney failure, serious liver disease, need oxygen for COPD, or have had a major stroke.

See 6 more

Treatment Details

Interventions

Aspirin and Clopidogrel (Antiplatelet agents)
Endovascular intervention (Procedure)

Trial OverviewThe study compares two approaches: one group receives only aspirin and clopidogrel as maximal medical therapy, while another undergoes an endovascular procedure alongside medication. The goal is to see which method better improves brain function related to thinking and memory.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Endovascular armExperimental Treatment1 Intervention

Subjects meet all inclusion criteria and were randomized to intervention

Group II: Non-Randomized ArmActive Control1 Intervention

Subject meets all inclusion criteria EXCEPT abnormal CTP. Subjects are not randomized and are eligible for only best medical management

Group III: Medical armActive Control1 Intervention

Subjects meet all inclusion criteria and were randomized to best medical management