Administration of a GLP-1 administration to reduce Brain injury follwing out of hospital cardiac arrest

GLP-1 ANALOGS FOR NEUROPROTECTION AFTER OUT-OF-HOSPITAL CARDIAC ARREST, A RANDOMIZED CLINICAL TRIAL - GLP-1 analogs for neuroprotection after Cardiac Arrest

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004311-45-DK

Enrollment

200

Registered

2014-02-21

Start date

2014-03-25

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

We investigate the efficacy of commercially available GLP-1 analog for reducing post anoxic brain injury in patients who remain comatose after having been resuscitation from out of hospital cardiac arrest. The study is a double blid placebo controlled trial. MedDRA version: 17.0 Level: PT Classification code 10007515 Term: Cardiac arrest System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Byetta Product Name: Byetta Pharmaceutical Form: Solution for infusion INN or Proposed INN: EXENATIDE CAS Number: 141758-74-9 Concentration unit: µg microgram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age =18 years, out-of-hospital cardiac arrest of presumed cardiac cause, unconsciousness (Glasgow Coma Score =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Conscious patients, pregnancy, out-of-hospital cardiac arrest of presumed non-cardiac cause, cardiac arrest after arrival in hospital, known bleeding diathesis, suspected or confirmed acute intracranial bleeding, suspected or confirmed acute stroke, temperature on admission 240 minutes from ROSC to randomisation, known allergies to GLP-1 analogs, know pancreatitis, diabetic ketoacidosis, intial blood glucose < 2.5 mmol/l.

Design outcomes

Primary

Measure	Time frame
Main Objective: To reduce to degree of post anoxic brain injury following resuscitation cardiac arrest, defined by a combined endpoint of efficacy (area under the Neuron Specific Enolasis -curve) and a feasibility defined as rapid initiation of study drug infusion;Secondary Objective: Neurological function scale score at 90 days of follow-up, survival, cognitive function test, study dryg safety;Primary end point(s): Co-primary end-point of 1) Feasibility (>90% initiation of study drug administration within 4 h following ROSC) and efficacy 2) area under the NSE curve;Timepoint(s) of evaluation of this end point: with the first 72 hours day of inclusion	—

Measure

Time frame

Main Objective: To reduce to degree of post anoxic brain injury following resuscitation cardiac arrest, defined by a combined endpoint of efficacy (area under the Neuron Specific Enolasis -curve) and a feasibility defined as rapid initiation of study drug infusion;Secondary Objective: Neurological function scale score at 90 days of follow-up, survival, cognitive function test, study dryg safety;Primary end point(s): Co-primary end-point of 1) Feasibility (>90% initiation of study drug administration within 4 h following ROSC) and efficacy 2) area under the NSE curve;Timepoint(s) of evaluation of this end point: with the first 72 hours day of inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): Blinded neurological prognostication at day 5 on ‘VAS scale’ by neurologist. Area under the S100B curve daily until and including day 5. Left ventricular ejection fraction on last in-hospital echocardiogragram performed in patients regaining consciousness. Composite outcomes of all-cause mortality and poor neurological function modified Rankin Scale (mRS) 4 and 5) at 30 days. Registry based follow-up for vital status at 180 days and telephone based assessment of Cerebral Performance Category and modified Ranking Scale at 180 days. Safety (number adverse invents requiring termination of study drug infusion);Timepoint(s) of evaluation of this end point: ICY admission (usually 7 days), follow-up at 90 and 180 day	—

Measure

Time frame

Secondary end point(s): Blinded neurological prognostication at day 5 on ‘VAS scale’ by neurologist. Area under the S100B curve daily until and including day 5. Left ventricular ejection fraction on last in-hospital echocardiogragram performed in patients regaining consciousness. Composite outcomes of all-cause mortality and poor neurological function modified Rankin Scale (mRS) 4 and 5) at 30 days. Registry based follow-up for vital status at 180 days and telephone based assessment of Cerebral Performance Category and modified Ranking Scale at 180 days. Safety (number adverse invents requiring termination of study drug infusion);Timepoint(s) of evaluation of this end point: ICY admission (usually 7 days), follow-up at 90 and 180 day

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Countries

Denmark

Contacts

Public ContactCardiology Intensive Care Unit B214

Copenhagen University Hospital Rigshospitalet, Department of Cardiology B 2143

jesper.kjaergaard.01@regionh.dk4535452143

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026