RCT of Ghrelin in Stroke Patients

What Was Tested

This registered phase 2 trial tested Ghrelin.

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.

It had two arms (groups): Ghrelin treatment (experimental) and Standard care (no intervention).

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

The registry classes the interventions as drug.

More on the Plan

The researchers will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT.

This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: pre-stroke disability defined as mrs ≥ 2,; life expectancy shorter than one year,; child-bearing potential.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Ghrelin group and the comparison group should start out alike.

The Ghrelin group and the comparison group ran side by side rather than switching.

Being open-label, the Ghrelin study did not mask who received what.

It started in 2023-10 with completion listed for 2024-12-31.

It ran at 3 sites in Netherlands (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: National Institutes of Health Stroke Scale score (time frame: 7 days after stroke onset).

It also tracked 9 secondary outcomes, for example Modified Rankin Scale score, Mortality, National Institutes of Health Stroke Scale score, National Institutes of Health Stroke Scale score, Telephonic Montreal Cognitive Assessment and Infarct size.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Ghrelin in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.