RCT of Ghrelin in Stroke Patients (MR GENTLE)

Rijnstate Hospital

Status and phase: Not yet enrolling; Phase 2

Conditions: Stroke, Ischemic

Treatments: Drug: Ghrelin

Study type: Interventional

Funder types: Other

Identifiers

NCT05726240

MR GENTLE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Ghrelin treatment

Experimental group

Description:

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.

Treatment:

Drug: Ghrelin

Standard care

No Intervention group

Description:

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