A multicentre, randomised controlled Trial of Exenatide versus standard care in Acute Ischemic Stroke (TEXAIS)

Phase 1

• Conditions: Acute ischaemic stroke; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004325-88-FI
• Lead Sponsor: Monash University - Eastern Health Clinical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

- Males and females 18 years or older
- Acute Ischaemic stroke – (CT to exclude haemorrhagic stroke)
- Blood sugar level on admission = 4mmol/L
- First trial treatment possible within 9 hours of stroke onset
- Pre-morbid modified Rankin Scale (mRS) score of 0-2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 450

Exclusion Criteria

- Haemorrhagic stroke
- Poor clinical prognosis /palliation. (Judged to be unlikely to survive beyond 14 days post stroke)
- Any known allergy or hypersensitivity to Exenatide
- Females who are pregnant (known or suspected) or currently breastfeeding
- Any past history of pancreatitis or evidence of active pancreatitis
- History of active severe gastrointestinal disease (including but not limited to gastroparesis and dumping syndrome)
- Current chronic kidney disease stage 4 or 5 (creatinine clearance <30ml/min)
- Current participation in another interventional clinical trial.
- Inability to provide consent (participant or person responsible as local laws apply)
- Current use of Exenatide (Byetta®), or other GLP-1 agonist diabetes medication
- Patients considered unlikely to be able to be followed up at 3 months (including but not limited to geographical location of patient at 3 months)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified