Actively Recruiting

Phase 2
Phase 3
Age: 21Years - 80Years
All Genders
NCT07282041

Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis

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

130

Participants Needed

1

Research Sites

258 weeks

Total Duration

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AI-Summary

What this Trial Is About

One important mechanism of action of GLP1 RA is the improvement in endothelial function, which may be evaluated by the assessment of cerebral vasodilatory reserve (CVR) in patients with severe ICAD. The investigators believe that GLP1 RA would be beneficial for patients with severe ICAD and lead to an improvement in cerebral vasodilatory reserve (CVR) in patients with severe and recently symptomatic stenosis of intracranial carotid artery (ICA) or middle cerebral artery (MCA). In this open label randomised clinical trial, patients with recently symptomatic and severe stenosis of intracranial carotid artery (ICA) or middle cerebral artery (MCA) with impaired cerebral vasodilatory reserve (CVR) will be included. CVR will be measured with transcranial Doppler (TCD) breath holding index and acetazolamide-challenged single photon emission computed tomography (SPECT). Patients meeting the eligibility criteria would be randomised to receive best medical therapy (according to the international guidelines and institutional practices) or Dulaglutide subcutaneous injection (0.75mg and titrating to 1.5mg, if indicated) once a week, in addition to the best medical therapy. CVR will be measured again at the completion of 1 year. MRI of the brain will be repeated to evaluate any new ischaemic brain lesions. All patients would be followed up for two years for cerebral ischaemic events. The investigators hypothesize that addition of GLP1 RA therapy would lead to a reduction of at least 4 units in CVR on SPECT as compared to best medical therapy.

CONDITIONS

Official 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 inclusive
  • Able to provide consent
  • Modified Rankin Score of 3 or less
  • Patients with transient ischemic attack (TIA) or mild stroke with severe stenosis of intracranial carotid artery (ICA) or middle cerebral artery (MCA) and impaired cerebral vasodilatory reserve within the previous 3 months
Not Eligible

You will not qualify if you...

  • Chronic kidney disease stage 5 (eGFR less than 15 mL/min) or on dialysis
  • Cancer diagnosed within the past 3 years
  • Currently planned for coronary or carotid artery revascularization
  • History of pancreatitis
  • History of medullary thyroid cancer
  • Atrial fibrillation
  • Any condition likely to limit protocol compliance as judged by the investigator
  • For diabetic patients, use of Sodium-glucose cotransporter 2 (SGLT2) inhibitors or pioglitazone during the study, unless these can be stopped without affecting medical condition
  • Known allergies to Acetazolamide
  • Women who are pregnant or breastfeeding

AI-Screening

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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

CONTACT

L

Lily YH Wong, RN

CONTACT

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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