Desmoteplase in Acute Ischemic Stroke, Study 12649A DIAS-4 26 Aug 2008

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel-group, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke. Study 12649A DIAS-4 26 Aug 2008

• IRAS ID

  5725

• Contact name

  Gary Ford/ Sue Lafferty

• Sponsor organisation

  H Lundbeck A/S

• Eudract number

  2008-005539-14

• ISRCTN Number

  N/A

• Research summary

  Stroke is a leading cause of mortality and a major cause of long term disability. About 85% of acute strokes are ischemic strokes (sudden blockage of blood supply to the brain). They are mainly caused by blood clots that block blood vessels in the brain, stopping the flow of blood and resulting in tissue death. Loss of brain tissue can result in mental and/or physical disability.Currently, the only approved treatment for ischemic stroke must be used within 3 hours after onset of the stroke. We urgently need treatments that can be used beyond this time.Desmoteplase is a new drug that stimulates the breakdown of blood clots, re-opening the blood vessels, restoring blood flow and so reducing the amount of tissue death. We hope that desmoteplase can be used up to 9 hours after the onset of an ischemic stroke.This study investigates the effictiveness and safety of desmoteplase in patients who have had an ischemic stroke and who can be treated within 3-9 hours. Additionally, it will investigate how quickly desmoteplase is broken down, assess the body??s immune response to desmoteplase, the impact of treatment on the patient??s quality of life and their use of health service resources. Patients are randomly allocated to receive a single dose of either desmoteplase or placebo (dummy drug) by injection into a vein. Patients are then followed up in hospital, or as out-patients, for 3 months. Patients have a brain scan before they are treated (to confirm that they have had an ischemic stroke) and another within 24 hours of treatment to assess progress. At regular intervals throughout the study, the patient??s clinical condition is assessed, heart function monitored (ECGs, blood pressure, pulse rate, temperature) and blood samples taken for analysis. This is an international study funded by H Lundbeck A/S.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  08/H0906/140

• Date of REC Opinion

  15 Jan 2009

• REC opinion

  Further Information Favourable Opinion