The primary objective of this study is to assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to assess the effect of ghrelin on the
severity of the neurological deficit at seven days after symptom onset in
patients with acute ischemic stroke caused by large vessel occlusion of the
anterior circulation and treated with EVT.
Secondary outcome
Secondary objectives are assessment of effects of ghrelin on
• functional outcome at 90 days (expressed as the score on the modified Rankin
Scale (mRS)),
• neurological deficit at one and three days after symptom onset (expressed as
scores on the NIHSS),
• infarct size at day 3±1 (based on MRI measurements),
• blood glucose levels at days 1-7,
• mean blood pressure at days 1-7,
• temperature at days 1-7,
• safety (number of SAEs; mortality).
Background 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.
Study objective
The primary objective of this study is to assess the effect of ghrelin on the
severity of the neurological deficit at seven days after symptom onset in
patients with acute ischemic stroke caused by large vessel occlusion of the
anterior circulation and treated with EVT.
Study design
This will be a phase 2 multicenter clinical trial with random treatment
allocation, open label treatment and blinded endpoint assessment (PROBE
design).
Intervention
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 burden and risks
A detailed risk analysis is described in chapter 12.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
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.
Exclusion criteria
- pre-stroke disability defined as mRS >=2,
- life expectancy shorter than one year,
- child bearing potential.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001632-28-NL |
| CCMO | NL81487.091.22 |