Trial of EXenatide in Acute Ischaemic Stroke
关键词
抽象
日期
最后验证: | 07/31/2019 |
首次提交: | 07/12/2017 |
提交的预估入学人数: | 09/16/2017 |
首次发布: | 09/18/2017 |
上次提交的更新: | 08/19/2019 |
最近更新发布: | 08/21/2019 |
实际学习开始日期: | 11/22/2017 |
预计主要完成日期: | 12/30/2020 |
预计完成日期: | 12/30/2021 |
状况或疾病
干预/治疗
Drug: active
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: active Patients will receive exenatide injections | Drug: active 5μg subcutaneously twice daily for five days, commencing within 9 hours of symptom onset |
No Intervention: standard care/no intervention standard care for stroke as per hospital protocol |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Males and females 18 years or older - Acute Ischaemic Stroke - CT brain exclusion of haemorrhagic stroke - Blood glucose level on admission ≥ 4mmol/L - First trial treatment possible within 9 hours of stroke onset - Pre-morbid /mRS score of 0-2 Exclusion Criteria: - Haemorrhagic stroke - Poor clinical prognosis /palliation (considered 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) |
结果
主要结果指标
1. improved neurological outcome [7 days]
次要成果指标
1. post stroke hyperglycaemia [90 days]
2. Modified Rankin Scale [90 days]
3. NIHSS [90 days]