RCT of Ghrelin in Stroke Patients

NCT05726240 | Unknown Phase 2 DMC

• 1 other identifier: MR GENTLE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke, Ischemic

Keywords

Endovascular thrombectomy; Ghrelin

Outcome Measures

Primary Outcomes (1)

• National Institutes of Health Stroke Scale score

  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.

  7 days after stroke onset

Secondary Outcomes (9)

• Modified Rankin Scale score

  90 days after stroke onset

• Mortality

  90 days after stroke onset

• National Institutes of Health Stroke Scale score

  24 hours after stroke onset

• National Institutes of Health Stroke Scale score

  72 hours after stroke onset

• Telephonic Montreal Cognitive Assessment

  90 days after stroke onset

Study Arms (2)

Ghrelin treatment

EXPERIMENTAL

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.

Drug: Ghrelin

Standard care

NO INTERVENTION

Treatment in the standard group consists of local practices for the treatment of stroke, including intravenous thrombolysis, if indicated.

Interventions

Ghrelin DRUG

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.

Ghrelin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (3)

Medisch Spectrum Twente

Enschede, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Publications (1)

• Omes QPM, van der Veen D, Kersten CJBA, Arntz RM, Filius PMG, van den Wijngaard IR, van der Worp HB, Hofmeijer J. MR GENTLE-multicentre randomised controlled trial of ghrelin in anterior circulation ischaemic stroke treated with endovascular thrombectomy: a phase 2 trial. Trials. 2026 Jan 16. doi: 10.1186/s13063-026-09426-8. Online ahead of print.

  PMID: 41546024 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jeannette Hofmeijer, MD, PhD

CONTACT

0880058877; jhofmeijer@rijnstate.nl

Daphne van der Veen, MSc

CONTACT

vascularsurgery@rijnstate.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: PROBE design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

NL (3)