Theophylline Effect in Acute Ischemic Stroke Trial

Phase 1

• Conditions: Acute ischemic stroke patients eligible for standard intravenous recombinant tissue plasminogen activator (rtPA) thrombolytic therapy with magnet resonance imaging (MRI)-proved infarction; MedDRA version: 19.0Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001989-42-DK
• Lead Sponsor: Boris Modrau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-02
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•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

Exclusion Criteria

•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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this study is to evaluate safety and efficacy of add-on Teofylin treatment to standard thrombolytic therapy in patients with MR-proved acute ischemic stroke. The study is designed as a randomized controlled trial comparing add-on Teofylin to placebo. The main interests are to demonstrate the tissue effect of Teofylin by measuring the infarct growth assessed by multimodal MRI as well as improved early clinical outcome;Secondary Objective: Not applicable;Primary end point(s): Dual Primary Outcome Measures<br>•Infact growth at 22-32 hours after add-on Teofylin treatment<br>•Clinical improvement at 22-32 hours after add-on Teofylin treatment;Timepoint(s) of evaluation of this end point: 22-32 hours after add-on Teofylin treatment