A Prospective, Randomised, Placebo Controlled, Double Blind Trial About Safety and Efficacy of Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
Overview
- Phase
- Phase 3
- Intervention
- Cerebrolysin
- Conditions
- Stroke
- Sponsor
- Ever Neuro Pharma GmbH
- Enrollment
- 119
- Locations
- 15
- Primary Endpoint
- Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal).
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Detailed Description
The current trial should evaluate a combined treatment using Cerebrolysin immediately after thrombolysis to guarantee that the neurotrophic components are able to reach the endangered brain areas efficiently. An early start of treatment should guarantee rescue of most of the neurons reducing the overall damage.The study follows the design of pure thrombolytic trials to investigate, if the early neuroprotective treatment with Cerebrolysin is able to improve the overall outcome of patients at the day 90 evaluation visit. Due to the initial findings special emphasis will be also put on analysing the speed of recovery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Evidence of intracranial haemorrhage (ICH) on the CT-scan
- •Violation of inclusion criteria not approved by clinical study director or study safety officer
- •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
Arms & Interventions
Cerebrolysin
Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Intervention: Cerebrolysin
0.9% Saline Solution
0.9% Saline Solution, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Intervention: 0.9% Saline Solution
Outcomes
Primary Outcomes
Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal).
Time Frame: Day 90
Secondary Outcomes
- 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.