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

What Was Tested

This randomized controlled trial paper looks at Cerebrolysin.

Previous clinical trials support therapeutic effects in stroke patients.

Who Took Part

According to the abstract, 119 patients were involved.

PubMed indexes the participants as young adults, adults, middle-aged adults and older adults, both men and women.

This placebo-controlled, double-blind trial involved 119 patients with acute ischaemic hemispheric stroke, randomly assigned to a combined treatment with alteplase plus Cerebrolysin or placebo (administered 1 h after thrombolytic treatment) starting within three-hours after onset of symptoms.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The patients were allocated by chance, so the Cerebrolysin group and the comparison group should start out alike.

As a double-blind Cerebrolysin study, the assignments were hidden from both participants and investigators until the end.

Some patients received a placebo instead of Cerebrolysin, giving a reference point.

Primary outcome was the modified Rankin Scale at day 90.

A sequential design with interim analyses was applied.

What Was Measured

Topics PubMed links to this paper include Amino Acids, Brain Ischemia, Fibrinolytic Agents, Neuroprotective Agents, Stroke and Tissue Plasminogen Activator.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cerebrolysin in 119 patients.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2013 (International journal of stroke : official journal of the International Stroke Society), a journal based in United States.

More context: the Cerebrolysin compound page, all human trials.