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Multicentre Randomised trial of Ghrelin in anterior circulation ischemic stroke treated with endovascular thrombectomy. A randomized phase 2 trial

Multicentre Randomised trial of Ghrelin in anterior circulation ischemic stroke treated with endovascular thrombectomy. A randomized phase 2 trial - MR GENTLE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51856
Enrollment
80
Registered
2023-04-03
Start date
2023-06-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

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.

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: - pre-stroke disability defined as mRS >=2, - life expectancy shorter than one year, - child bearing potential.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)