Clinical trial NCT05726240: RCT of Ghrelin in Stroke Patients
Official title: Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Stroke, Ischemic
Keywords: Endovascular thrombectomy
Ghrelin
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a phase 2 multicenter clinical trial with random treatment allocation, open label treatment and blinded endpoint assessment (PROBE design). The intervention contrast will be intravenous acylated ghrelin in addition to standard care (intervention group) vs. standard care alone (control group).
Primary purpose: TREATMENT

Brief summary: About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome in these patients. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter also known as the 'hunger hormone.' Treatment with acylated ghrelin consistently improved functional and histological recovery in in vitro and in vivo models of ischemic stroke.

Detailed description: We will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT. The study population will be drawn from adult patients with acute ischemic stroke treated with EVT at UMC Utrecht, Rijnstate, MST or Isala.

Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.

Eligibility criteria: Inclusion Criteria:

* a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery) confirmed by neuro-imaging (CTA or MRA),
* treatment with EVT, defined as groin puncture in the angio suite,
* CT or MRI ruling out intracranial hemorrhage,
* a pre-EVT score of at least 10 on the NIHSS,
* age of 18 years or older,
* written informed consent (deferred).

Exclusion Criteria:

* pre-stroke disability defined as mRS ≥ 2,
* life expectancy shorter than one year,
* child-bearing potential.

Primary outcomes:
measure: National Institutes of Health Stroke Scale score
timeFrame: 7 days after stroke onset
Secondary outcomes:
measure: Modified Rankin Scale score
timeFrame: 90 days after stroke onset
measure: Mortality
timeFrame: 90 days after stroke onset
measure: National Institutes of Health Stroke Scale score
timeFrame: 24 hours after stroke onset
measure: National Institutes of Health Stroke Scale score
timeFrame: 72 hours after stroke onset
measure: Telephonic Montreal Cognitive Assessment
timeFrame: 90 days after stroke onset
measure: Infarct size
timeFrame: 72 hours after stroke onset
measure: Blood glucose levels
timeFrame: Days 1-7 after stroke onset
measure: Blood pressure
timeFrame: Days 1-7 after stroke onset
measure: Body temperature
timeFrame: Days 1-7 after stroke onset
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
References: