REstart or STop Antithrombotics Randomised Trial (RESTART)
Research type
Research Study
Full title
REstart or STop Antithrombotics Randomised Trial (RESTART)
IRAS ID
113625
Contact name
Rustam Al-Shahi Salman
Contact email
Sponsor organisation
University of Edinburgh
Eudract number
2012-003190-26
Research summary
Research Summary
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. In this preliminary study of 720 such people who survive a brain haemorrhage, we will study the potentially beneficial effects of antiplatelet drugs such as aspirin 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.
Summary of Results
More than one-third of people who’ve survived brain haemorrhage stop taking oral anti-blood-clotting drugs, like aspirin. Normally taken to stop blood vessels getting blocked, so-called antiplatelet drugs increase the risk of bleeding in general.
RESTART was a randomised trial involving 537 survivors of brain haemorrhage in the UK. Participants were mostly men over the age of 70. They all had diseases that block blood flow due to clotting, but had then stopped taking antiplatelet drugs after their brain haemorrhage. RESTART split these people into two groups: half were encouraged to start antiplatelet drugs, and half were encouraged to stay off them. We kept track of those who had recurrent bleeding and any major event to do with blocked blood flow, including heart attack and stroke.
The main results published in the Lancet in 2019 showed that, overall, fewer people who started antiplatelet drugs had another brain haemorrhage compared to those who kept off these drugs. The number whose blood vessels became seriously blocked was about the same in both groups. It looked like the risk of antiplatelet drugs for people with brain haemorrhage is small enough not to outweigh the benefits of these drugs for stopping heart attacks and strokes.
Following these main results, we continued to follow participants for another two years.
• 22 of 268 participants who started an antiplatelet drug had another brain haemorrhage compared with 25 of 268 participants who avoided these drugs.
• Overall, 72 of 268 participants who started an antiplatelet drug had a major event involving bleeding or blockage of blood flow, compared with 87 of 268 participants who avoided these drugs.
• Those findings are consistent with the known effects of antiplatelet drugs.
• It looks like the risk of antiplatelet drugs might be too small to exceed the established benefits of these drugs for preventing heart attacks and strokes.
• These promising findings should be investigated in larger trials to be sure about the effects of antiplatelet drugs for people with brain haemorrhage.REC name
Scotland A: Adults with Incapacity only
REC reference
12/SS/0138
Date of REC Opinion
2 Nov 2012
REC opinion
Further Information Favourable Opinion