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Antiplatelet agents

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

Phase 2

Waitlist Available

Led By David Hasan, MD

Research Sponsored by David Hasan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All occlusion is due to atherosclerotic disease

Complete occlusion of cervical ICA on imaging studies (MRA or CTA) and confirmed with DSA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12-month

Awards & highlights

NIA-SCORE Trial Summary

This trial will test whether a new treatment can help patients with a specific type of stroke caused by atherosclerotic disease. If successful, the treatment could help reduce the risk of recurrent stroke and cognitive decline.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Aspirin and clopidogrel can cause bleeding issues, stomach pain, bruising easily, or allergic reactions. Endovascular intervention might lead to risks like stroke during the procedure, artery damage, or complications from anesthesia.

NIA-SCORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My blockage is caused by hardening of the arteries.

Select...

My imaging tests show a complete blockage in the artery in my neck.

Select...

I am 21 years old or older.

Select...

I have had a stroke or a mini-stroke (TIA) in the past.

Select...

My cognitive test scores are lower than normal for my age, gender, and education level.

Select...

My current treatment is not working for my condition.

NIA-SCORE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Cognitive Score

MoCA Score

Secondary outcome measures

Death

Hemorrhage

Stroke

Other outcome measures

Lactate

MTT

Size of amygdala

+1 more

NIA-SCORE Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endovascular intervention

2020

Completed Phase 2

~240

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

David HasanLead Sponsor

3 Previous Clinical Trials

96 Total Patients Enrolled

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,473 Total Patients Enrolled

David Hasan, MD5.02 ReviewsPrincipal Investigator - Duke University

University of Iowa

1 Previous Clinical Trials

66 Total Patients Enrolled

5Patient Review

I had complications after brain surgery for Acoustic neuroma but thankful to have Dr. Hasan to save my life with VP Shunt. Highly recommend him!

Media Library

Aspirin and Clopidogrel (Antiplatelet agents) Clinical Trial Eligibility Overview. Trial Name: NCT04219774 — Phase 2

Carotid Artery Blockage Research Study Groups: Non-Randomized Arm, Medical arm, Endovascular arm

Carotid Artery Blockage Clinical Trial 2023: Aspirin and Clopidogrel Highlights & Side Effects. Trial Name: NCT04219774 — Phase 2

Aspirin and Clopidogrel (Antiplatelet agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04219774 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are commonly treated with Endovascular intervention?

"Endovascular intervention is most often employed to treat stroke, but can also be used to manage peripheral arterial disease (PAD), cardiac mortality due to myocardial infarction, and back-related issues."

Answered by AI

Is enrollment for this research endeavor currently open?

"Confirmed. According to clinicaltrials.gov, this healthcare investigation is currently recruiting patients as it was initially posted on April 1st 2019 and lastly edited on November 17th 2022. 40 people are required for the trial conducted at one medical facility."

Answered by AI

Is this research groundbreaking in any way?

"Since 2005, research into Endovascular intervention has been ongoing with Abbott sponsoring the first trial that year. The 15480-person study culminated in Phase 4 approval and currently there are 191 active trials conducted across 57 nations throughout 1410 cities."

Answered by AI

What is the uppermost limit of individuals participating in this research study?

"Affirmative. According to the clinicaltrials.gov site, this research endeavor has been ongoing since April 1st 2019 and was recently updated on November 17th 2022; and they are looking for 40 volunteers from a single location."

Answered by AI

What other evidence is there for the efficacy of Endovascular intervention?

"Presently, 191 active clinical trials examining Endovascular intervention have been allocated to 53 Phase 3 procedures. With the majority of these studies based in New Orleans, Louisiana; a total of 4007 sites are researching this medical procedure."

Answered by AI

What are the long-term effects of Endovascular treatment on patients?

"Due to there being limited evidence of efficacy, our team at Power ranks the safety of endovascular intervention as a 2 on a scale from 1-3."

Answered by AI

Who has been deemed eligible to participate in this research endeavor?

"This clinical trial is recruiting for 40 individuals aged 21 or above with overinclusion and scoring lower than 26 on the MoCA Test, or receiving an abnormal result from another battery test. Additionally, they must have a complete occlusion of cervical ICA visible through MRA/CTA scans accompanied by a TIA stroke history, increased mean transit time (MTT) and/or time to peak (TTP) which exceeds 10cc > 4 seconds in the affected hemisphere when compared to its unaffected counterpart. All participating patients must be undergoing best medical treatment according to Class A & B as specified under COICA classification while consent may be"

Answered by AI

Does this clinical trial accept participants aged below seventy-five years old?

"As indicated by the inclusion criteria for this clinical trial, only individuals between 21-90 years old are suitable applicants. Moreover, there are 58 studies regarding minors aged below 18 and 1,224 concerning seniors above 65."

Answered by AI

Recent research and studies

Journal of NeurosurgeryJournal

Cognitive and Cerebral Hemodynamic Effects of Endovascular Recanalization of Chronically Occluded Cervical Internal Carotid Artery: Single-center Study and Review of the Literature

Zanaty, Mario, Susanna Howard, Jorge A. Roa, Carlos M. Alvarez, David K. Kung, David J. McCarthy, Edgar A. Samaniego, et al.. 2020. “Cognitive and Cerebral Hemodynamic Effects of Endovascular Recanalization of Chronically Occluded Cervical Internal Carotid Artery: Single-center Study and Review of the Literature”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2019.1.jns183337.

World NeurosurgeryJournal

Letter to the Editor Regarding “estimation and Recanalization of Chronic Occluded Internal Carotid Artery: Hybrid Operation by Carotid Endarterectomy and Endovascular Angioplasty

Zanaty, Mario, Edgar A. Samaniego, and David M. Hasan. 2019. “Letter to the Editor Regarding “estimation and Recanalization of Chronic Occluded Internal Carotid Artery: Hybrid Operation by Carotid Endarterectomy and Endovascular Angioplasty””. World Neurosurgery. Elsevier BV. doi:10.1016/j.wneu.2018.09.033.

World Neurosurgery: XJournal

Recanalization of the Chronically Occluded Internal Carotid Artery: Review of the Literature

Zanaty, Mario, Jorge A. Roa, Pascal M. Jabbour, Edgar A. Samaniego, and David M. Hasan. 2020. “Recanalization of the Chronically Occluded Internal Carotid Artery: Review of the Literature”. World Neurosurgery: X. Elsevier BV. doi:10.1016/j.wnsx.2019.100067.

NeurosurgeryJournal