Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-80
SponsorNational University of Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 21 - 80 years old inclusive,
Able to provide consent,
Score 3 or less on the Modified Rankin Score (mRS),
Patients with TIA or mild stroke with severe stenosis of intracranial ICA or MCA and impaired CVR within previous 3-months of acute stroke or TIA
Disqualifiers
Chronic kidney disease stage 5 (eGFR<15 mL/min) or on dialysis,
Cancer diagnosed within past 3 years,
Currently being planned for coronary or carotid artery revascularization,
History of previous pancreatitis,
Trial design
Design model
Parallel
Treatments tested in this trial
Dulaglutide
DrugStudy participants would be randomised (1:1) to receive standard medical therapy or Dulaglutide plus standard medical therapy
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: DulaglutideExperimental treatment 1 intervention
Group B: Standard medical therapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To evaluate whether GLP1 RA (Dulaglutide) therapy would improveme cerebral vasodilatory reserve by at least 4 points in patients with severe stenosis of ICA or MCA
To evaluate whether GLP1 RA (Dulaglutide) therapy would lead to an improvement in cerebral vasodilatory reserve (CVR) by at least 4 points in patients with recently symptomatic and severe stenosis of ICA or MCA.
Time frame
within 1 yearSecondary outcomes
1
To evaluate the impact of Dulaglutide on recurrence of cerebral ischaemic event within 1 year.
To evaluate the impact of GLP1 agonist (Dulaglutide) therapy on recurrence of cerebral ischaemic event in patients with recently symptomatic and severe stenosis of intracranial internal carotid artery (ICA) or middle cerebral artery (MCA) within 1 year (to evaluate treatment effect during therapy).
Time frame
within 1year2
To evaluate whether Dulaglutide would reduce MACE within 2 years
To evaluate whether GLP1 agonist (Dulaglutide) therapy would reduce myocardial infarction (MI), all-cause mortality, and major adverse cardiovascular events (MACE, including cardiovascular death, nonfatal MI, and/or nonfatal ischaemic stroke) within 2 years (to evaluate sustained benefits).
Time frame
within 2 yearsSponsors and contacts
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Source ClinicalTrials.gov