RCT of Ghrelin in Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

PROBE design

Study Groups

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Ghrelin treatment

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.

Group Type EXPERIMENTAL

Ghrelin

Intervention Type 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.

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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).