Actively Recruiting

Phase 2
Phase 3
Age: 21Years - 80Years
All Genders
ID07282041

Role of Glucagon-like Peptide 1 Receptor Agonist (GLP1 RA) Dulaglutide on Cerebral Hemodynamics in Patients With Severe and Symptomatic Stenosis of Intracranial Internal Carotid or Middle Cerebral Artery With Impaired Cerebral Vasodilatory Reserve - an Open-label Randomised Clinical Trial

Led by National University of Singapore · Updated on 2025-12-23

130

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of glucagon-like peptide 1 receptor agonist (GLP1 RA) therapy, specifically Dulaglutide, on patients with severe and recently symptomatic narrowing (stenosis) of the intracranial carotid artery (ICA) or middle cerebral artery (MCA). The study focuses on improving cerebral vasodilatory reserve (CVR), an important measure of blood vessel function in the brain, in patients with intracranial atherosclerotic disease (ICAD). Researchers hypothesize that GLP1 RA may benefit these patients by improving blood flow and reducing stroke risk. Participants will be randomly assigned to receive either the best medical therapy alone or in combination with Dulaglutide given as a weekly subcutaneous injection starting at 0.75 mg and possibly increasing to 1.5 mg. The study is open-label and lasts for two years, with CVR measured at baseline and after one year using transcranial Doppler breath holding index and acetazolamide-challenged single photon emission computed tomography (SPECT). Brain MRI scans will also be performed to check for new ischemic lesions. Throughout the study, participants will be monitored for cerebral ischemic events for two years. Researchers will assess changes in CVR and the occurrence of strokes, transient ischemic attacks (TIA), myocardial infarctions, and major adverse cardiovascular events (MACE). Safety will be tracked by recording any side effects related to Dulaglutide. The trial aims to provide important information about the potential benefits of GLP1 RA therapy in managing severe ICAD.

CONDITIONS

Brief Title

Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 21 to 80 years old inclusive
  • Able to provide consent
  • Score 3 or less on the Modified Rankin Score (mRS)
  • Patients with transient ischemic attack (TIA) or mild stroke with severe stenosis of intracranial ICA or MCA and impaired cerebral vasodilatory reserve within previous 3 months of acute stroke or TIA
Not Eligible

You will not qualify if you...

  • Chronic kidney disease stage 5 (eGFR <15 mL/min) or on dialysis
  • Cancer diagnosed within past 3 years
  • Currently planned for coronary or carotid artery revascularization
  • History of previous pancreatitis
  • History of medullary thyroid cancer
  • Atrial fibrillation
  • Any other condition likely to limit protocol compliance
  • For diabetic patients, not on SGLT2 inhibitors or pioglitazone during the study unless safely stopped
  • Known allergies to Acetazolamide
  • Women who are pregnant or breastfeeding

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 year

Participants who are eligible will be randomized to receive either Dulaglutide once weekly plus standard medical therapy or standard medical therapy alone for their condition.

Weekly visits for Dulaglutide injections and follow-up assessments as per treatment schedule

Follow-up

Duration - 1 year

Participants will be followed after treatment to monitor for cerebral ischemic events and major adverse cardiovascular events for an additional year.

Periodic follow-up visits over 1 year

Trial Site Locations

Total: 1 location

1

National University Hospital

Singapore, Singapore, 119228

Actively Recruiting

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Research Team

V

vijay K sharma, MD

L

Lily YH Wong, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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