Acute ischemic stroke in the A. cerebri media territory MedDRA version: 9.1 Level: LLT Classification code 10055221 Term: Ischemic stroke MedDRA version: 9.1 Level: LLT Classification code 10061256 Term: Ischaemic stroke MedDRA version: 9.1 Level: LLT Classification code 10027580 Term: Middle cerebral artery stroke MedDRA version: 9.1 Level: PT Classification code 10061256 Term: Ischaemic stroke
Conditions
Interventions
Trade Name: Dociton 80 mg
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Center for Stroke Research Berlin - Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age = 18 2) Clinical syndrome of an acute ischemic middle cerebral artery stroke with a) an NIHSS score = 4 and compatible imaging or b) proof of non-lacunar MCA-infarction with an adequate imaging technique 3) Treatment has to start within 18 h after symptom onset 5) For premenopausal women: negative result of a pregnancy test and highly effective contraception (defined with a Pearl Index =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient is enrolled in another interventional trial. 2) Every severe or fatal disease, that reduces the life expectancy to less than 1 year, except the ischemic stroke. 3) Any contraindication to the administration of propranolol. 4) Clinically relevant interactions of propranolol with the necessary, administered medication prescribed by the treating physician. 5) Patient is already being treated with beta-blockers. 6) Patient is or was recently undergoing antiarrhythmic, immunosuppressive or antiinfective treatment. 7) Myocardial infarction during the last 3 months. 8) Heart rate > 110 bpm 9) any unstable or severe heart disease (i.e. heart failure NYHA III-IV) 10) severe chronic arterial hypertension 11) Patient is suffering from acute, uncontrolled hypotension at the time of screening. 12) Patient is suffering form a serious liver disease. 13) Alcohol or drug abuse. 14) Pregnancy or nursing period 15) The patient or his legal representative is not giving consent to the saving, archiving and forwarding of pseudonymic data. 16) Clinical or laboratory signs of infection warranting treatment. 17) Any other condition that could to the discretion of the Investigator impose hazards to the patient if study therapy was initiated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to assess the efficacy and safety of propranolol in middle cerebral artery stroke patients. The primary hypothesis is as follows Early administration of propranolol reduces the frequency of cardiovascular and/or neurological complications including vascular death in the first 30 days after acute ischemic stroke.;Secondary Objective: Secondary hypotheses are as follows: Early administration of propranolol improves neurological and functional outcome of patients with acute ischemic stroke. Early administration of propranolol reduces post-stroke immunodepression and therefore lowers the rate of pneumonia after acute ischemic stroke, without increasing the frequency of auto-aggressive, CNS antigen-specific T cells. Early administration of Propranolol influences alterations in cardiologic, electrophysiologic phenomenons as a reaction to autonomic dysregulation after acute ischemic stroke. Early administration of Propranolol reduces growth of infarct as determined by MRI examinations in the first 6 days.;Primary end point(s): Primary endpoint is the incidence of cardiovascular and/or neurological complications including vascular death within the first 30 days after acute ischemic stroke. These include: 1) Excessive hypertension, defined by the necessity of a new or second antihypertensive or a higher dosage. 2) Non-fatal episode of cardiovascular complications (as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, myocardial infarction, clinically relevant deterioration of or newly diagnosed heart failure) 3) Non-fatal episode of neurological complications (as recurrent stroke, intraparenchymal haemorrhage, intracranial hypertension) 4) Vascular death - defined as death through one of the above mentioned complications | — |
Countries
Germany
Outcome results
None listed