Extract

Background and study aims More than one third of the adults with a stroke due to bleeding into the brain - known as brain haemorrhage - are taking drugs to prevent clotting when they have a brain haemorrhage. These patients had previously suffered illnesses like angina, heart attack, or stroke due to blood vessel blockage, which is why they are treated with drugs to prevent further clots occurring. These drugs are usually stopped when the brain haemorrhage occurs. But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to restart these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again. We will study the potentially beneficial effects of three antiplatelet drugs (aspirin, clopidogrel, or dipyridamole) on the risks of heart attack, stroke and other clotting problems as well as their effect on the risk of a brain haemorrhage happening again. This information will help us to decide whether antiplatelet drugs are a promising treatment. If they are, we will recruit a much larger number of patients so that we can determine really reliably whether the beneficial effects of antiplatelet drugs on the risk of clotting outweigh any risks of a repeat brain haemorrhage for such people. Who can participate? We aim to recruit 720 men and women in the UK aged 18 years or more who survive a brain haemorrhage. If participants are unable to provide fully informed consent a relative or other legal representative may be approached for their consent. What does the study involve? Research staff will collect baseline information about each participant. Some participants may also have an additional MRI scan. Participants will be randomly allocated to either start or avoid antiplatelet medication. Over a period of at least two years we will collect information about participants’ progress, any medical problems and their adherence to the randomised treatment allocation (start or avoid antiplatelet medication). This follow up information will be obtained from participants, relatives and General Practitioners. What are the possible benefits and risks of participating? We do not know whether taking or avoiding antiplatelet medication is best, but participants have a chance to be exposed to the benefit of one or other strategy by participating. Some people find it beneficial to be part of a research study and to be under regular follow-up. The results of this study will help us to treat patients better in future. Participants may find the time spent completing one questionnaire each year inconvenient. Participants, who have agreed to have an MRI scan, may become claustrophobic in the MRI scanner - if this happens the scan would be stopped. Because MRI scans are so detailed, there is also a 1 in 37 chance of finding an abnormality on your MRI scan that is completely incidental to your brain haemorrhage. Where is the study run from and how long will it last? RESTART is run by a team at the Division of Clinical Neurosciences at the University of Edinburgh, UK and it will last for at least five years. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will begin in April 2013. Recruitment of participants to the trial will last for at least two years. Follow-up of these participants will continue for at least two years. Who is funding the study? RESTART is funded by the British Heart Foundation Who is the main contact? The UK Chief Investigator is Rustam Al-Shahi Salman and the Trial Manager is Karen Innes, and they can be contacted via [email protected].

Inclusion criteria

• intracerebral haemorrhage

Links

• ictrp
• isrctn