Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

NCT00840671 | Completed Phase 3

• 2 other identifiers: CR040301EudraCT-number: 2004-001729-11
• Study Type: interventional
• Target: 119
• Locations: 4 countries
• Sites: 14

Brief Summary

It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.

Conditions

Stroke

Keywords

Cerebrolysin; Alteplase; Ischemic Stroke; Modified Rankin Scale; NIH Stroke Scale; Barthel Index; Glasgow Outcome Score

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal).

  Day 90

Secondary Outcomes (4)

• NIH Stroke Scale Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed.

  90 days after start of treatment

• Glasgow Outcome Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed.

  90 days after start of treatment

• Barthel Index Score 90 days after start of treatment (or earlier in the event of patient withdrawal). Actual score or change from baseline score analysed.

  90 days after start of treatment

• Responders classified according to Barthel Index Score ≥95, Glasgow Outcome Score 0-1, NIHSS change from baseline score, 8 point improvement or total score 0-1 or NIHSS Distal Motor Function Score 0-1. Responder rates across each scale analysed.

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.

Drug: Cerebrolysin

0.9% Saline Solution

PLACEBO COMPARATOR

0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.

Drug: 0.9% Saline Solution

Interventions

Cerebrolysin DRUG

Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.

Cerebrolysin

0.9% Saline Solution DRUG

0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.

Also known as: NaCl

0.9% Saline Solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male inpatients.
• Age: 18-80 years.
• If female, patient must not be pregnant
• Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze,vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes haemorrhage.
• Onset of symptoms within 3 hours prior to initiation of rt-PA administration.
• Stroke symptoms are to be present for at least 30 minutes and have not significantly improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure or migraine disorder.
• Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating country.
• Patients who are unable to sign but who are able to understand the meaning of participation in the study may give an oral witnessed informed consent. These patients have to make clear undoubtful that they are willing to participate voluntarily and must be able to understand an explanation of the contents of the information sheet. A written consent has to be obtained as soon as possible.
• Willingness and ability to comply with the protocol.

You may not qualify if:

• Evidence of intracranial haemorrhage (ICH) on the CT-scan
• Failure to perform or to evaluate screening or baseline examinations
• Hospitalisation (except for study purposes) or change of concomitant medication 4 weeks prior to screening or during screening period
• Participation in another therapeutic clinical trial 3 months before baseline
• Patients with any history of prior stroke and concomitant diabetes
• Prior stroke within the last 3 months
• Platelet count of below 100x103/mm3
• Blood glucose \<50 or \>400 mg/dl (\<2.77 or \>22.15 mmol/L)
• Known haemorrhagic diathesis
• Manifest or recent severe or dangerous bleeding
• Known bacterial endocarditis, pericarditis
• Acute pancreatitis
• Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation
• Neoplasm with increased bleeding risk
• Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis

Sponsors & Collaborators

• Ever Neuro Pharma GmbH: lead
• JSW-Research Forschungslabor GmbH, Parkring 12, 8074 Grambach: collaborator

Study Sites (15)

Außenstelle Landesklinikum Donauregion Gugging

Gugging, 3400, Austria

Location

Universitätsklinik Innsbruck, Dept. of Neurology

Innsbruck, 6020, Austria

Location

LKH Klagenfurt, Abteilung für Neurologie

Klagenfurt, 9020, Austria

Location

AKH Linz, Abteilung Neurologie & Psychiatrie

Linz, 4021, Austria

Location

Krankenhaus der Barmherzigen Brüder/Abteilung für Neurologie

Vienna, 1020, Austria

Location

Klinicka Bolnicki Centar, Klinika za Nevrologiju

Rijeka, 51000, Croatia

Location

Clinical Hospital Split, Dept. of Neurology

Split, 21000, Croatia

Location

Medical School of Zagreb

Zagreb, 10000, Croatia

Location

University Hospital Sorrores Misericoridae

Zagreb, 10000, Croatia

Location

St. Ann's Hospital, Dept. of Neurology

Brno, 65691, Czechia

Location

Clinic of Neurology, Faculty Hospital Ostrava

Ostrava, 70852, Czechia

Location

Blessed Mary Anthony Hospital, Dept. of Neurology

Ostrava Vitkovice, 70384, Czechia

Location

University Hospital Plzen

Pilsen, 30460, Czechia

Location

University Hospital, Comenius University, Dept. of Neurology

Bratislava, 81369, Slovakia

Location

Clinical Hospital Centre Ljubljana

Ljubljana, 1525, Slovenia

Location

Related Publications (1)

• Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013 Feb;8(2):95-104. doi: 10.1111/j.1747-4949.2012.00901.x. Epub 2012 Sep 26.

  PMID: 23009193 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

cerebrolysin; Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Manfred Windisch, PhD

  JSW Research Forschungslabor GmbH

  STUDY DIRECTOR

• Wilfried Lang, MD

  Krankenhaus der Barmherzigen Brüder, 1020 Wien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 9, 2009
• First Posted: February 10, 2009
• Study Start: October 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 28, 2010

Record last verified: 2010-12

Locations

SL (1); CR (4); CZ (4); AU (5)