Beta-Blocker in Acute Ischemic Stroke – a prospective, randomized, double-blinded, placebo-controlled safety and efficacy trial of early treatment - BIAS

• Conditions: Acute ischemic stroke in the A. cerebri media territory; MedDRA version: 9.1Level: LLTClassification code 10055221Term: Ischemic stroke; MedDRA version: 9.1Level: LLTClassification code 10061256Term: Ischaemic stroke; MedDRA version: 9.1Level: LLTClassification code 10027580Term: Middle cerebral artery stroke; MedDRA version: 9.1Level: PTClassification code 10061256Term: Ischaemic stroke

• Registration Number: EUCTR2008-007031-41-DE
• Lead Sponsor: Center for Stroke Research Berlin - Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-14
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <1)
6) Informed Consent by patient

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

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