RCT of Ghrelin in Stroke Patients

Phase 2

Not yet recruiting

• Conditions: Stroke, Ischemic
• Interventions: Drug: Ghrelin

• Registration Number: NCT05726240
• Lead Sponsor: Rijnstate Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-22
• Last Update Posted: 2023-07-25
• Study Start: 2023-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ghrelin treatment	Ghrelin	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.

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale score	7 days after stroke onset	The primary outcome measure is the score on the National Institutes of Health Stroke Scale at seven days (±1) after stroke onset or at discharge, if earlier. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

Secondary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale score	72 hours after stroke onset	Scores on National Institutes of Health Stroke Scale at 72 hours after stroke onset. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Telephonic Montreal Cognitive Assessment	90 days after stroke onset	Score on the telephone version of the Montreal Cognitive Assessment at 90 days. The MoCA 5-minute protocol consists of 4 subtests examining 5 cognitive domains, including attention, verbal learning and memory, executive functions/language, and orientation. Total scores of the MoCA 5-minute protocol range between 0 and 30 with lower scores indicating a better cognition.
Blood pressure	Days 1-7 after stroke onset	Blood pressure at days 1-7 (or until discharge)
Modified Rankin Scale score	90 days after stroke onset	The score on the Modified Rankin Scale at 90 days after stroke onset. The mRS is an ordinal hierarchical scale that describes disabilities encountered post stroke, incorporating six categories from 0 (complete recovery) up to and including 5 (severe disability). 'Death' is assigned a score of 6 .
Mortality	90 days after stroke onset	Mortality at 90 days
Infarct size	72 hours after stroke onset	Infarct size at 72 hours (based on Magnetic resonance imaging measurements)
Blood glucose levels	Days 1-7 after stroke onset	Blood glucose levels at days 1-7 (or until discharge)
Body temperature	Days 1-7 after stroke onset	Body temperature at days 1-7 (or until discharge)

Trial Locations

Locations (3)

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands

Isala; 🇳🇱 Zwolle, Netherlands