Theophylline Effect in Acute Ischemic Stroke Trial - TEA-Stroke Trial

Boris Modrau0 个研究点目标入组 120 人开始时间: 2013年8月2日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•Subjects eligible for standard dose IV rtPA thrombolytic therapy within 4.5 hours of symptom onset in accordance to the national Danish inclusion /exclusion criteria for standard IV rtPA thrombolytic therapy
•Patients with acute hemispheric cerebral infarction as defined by DWI.
•National Institute of Health Stroke Scale (NIHSS) =4
•DWI lesion volume =1/3 of MCA territory or =1/2 of ACA or PCA territory
•Informed consent obtained.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•Age below 18 years
•Pre-stroke disability defined by modified Rankin Scale (mRS) >1
•Contraindication to MRI
•Acute infarction of the brainstem on diffusion weighted MRI at baseline
•Occlusion of the internal carotid artery or carotid-T on MRI at baseline
•Epilepsy and/or acute seizure
•Treatment with or allergic reaction to xanthines (Teofylin or its derivates)
•Pregnancy, breastfeeding, or positive pregnancy test (Negative pregnancy test prior to Teofylin administration required in fertile women up to 55 years of age)
•History of liver disease and/or alanine transaminase two times normal value
•History of thyroidal dysfunction
•Fever of more than 38.5 °C
•Potassium below normal value
•Electrocardiogram with signs of acute ischemic heart disease
•Congestive heart failure, or acute myocardial infarction within the last 6 months
•Reduced cooperation or other conditions that make it unlikely to precede the study or to follow the patient for three months
•Participation in any interventional study within the last 30 days

发起方

Boris Modrau