ASPIRING

Antiplatelet Secondary Prevention International Randomised study after INtracerebral haemorrhaGe

A video to help patients decide on taking part in the ASPIRING STUDY

This  video  is  about  the  aspiring  study. It  could  help  you  decide  about  taking  part. Doctor  Rustam  Salman  is  a  neurologist, professor  at  the  University  of  Edinburgh and  the  chief  investigator  of  the  study. I'll  tell  you  his  answers  to some  frequently  asked questions  about  Aspiring. Aspiring  is  for  people  who  have had  a  stroke  due  to  bleeding  in  the  brain, also  known  as  brain  haemorrhage. Brain  haemorrhage  survivors  are at  risk  of  having  another  stroke, heart  attack,  and  other clotting  or  bleeding  problems. Doctors  try  to  prevent these  problems  by  lowering  blood  pressure. Despite  that,  these  problems  affect about  one  in  ten  brain haemorrhage  survivors  every  year. An  international  team  of  researchers, led  by  the  University  of  Edinburgh are  aspiring  to  find  out if  aspirin  or  another  medicine like  it  called  clopidogrel, prevent  stroke,  heart  attack, and  death  after  brain  haemorrhage. These  medicines  thin  the  blood to  prevent  blood  clotting, but  they  may  also increase  the  risk  of  bleeding. Overall,  these  medicines  are  used  in standard  medical  practise  because  they  do more  good  than  harm  for people  without  brain  haemorrhage. Aspirin  and  lapidagrel  were safe  in  the  researchers  pilot  study  of 537  people  with  brain  haemorrhage in  the  UK  called  Restart. Now  the  researchers  want  to  find out  if  adding  one  of  these  medicines to  standard  care  is  acceptably  safe and  helps  a  wide  range of  brain  haemorrhage  survivors, compared  with  standard  care  alone. They're  doing  this  in  a  study  of  more than  4,000  people  worldwide. We  invite  you  to  join  the  aspiring  study. You  may  be  eligible  if you  have  had  a  brain  haemorrhage and  you  are  not  taking any  medicines  that  thin  your  blood. You're  given  information  leaflets  and answers  to  any  questions  that  you  may  have. If  you  want  to  take  part,  you must  complete  a  consent  form. But  you  don't  have  to  take  part. Either  way, your  medical  care  will  be  the  same. Take  as  long  as  you  need  to  decide. A  researcher  at  your  hospital  enters information  about  you  into a  secure  study  database. The  aspiring  database  will assign  you  to  one  of  two  options. Standard  care  or  standard  care with  a  daily  aspirin  or  clapdagrl  pill. You'd  have  an  equal  chance of  getting  either  option. The  database  decides  using a  process  called  randomization. You  and  your  doctors  will know  which  option  you  are  given. If  Aspiring  assigns  you  to start  Aspirin  or  clipdigrl, your  hospital  team  will write  the  first  prescription. After  that,  your  usual  doctor will  prescribe  the  medicine, and  you  should  keep  taking it  until  the  study  ends. If  Aspiring  assigns  you  to  standard  care, you  should  avoid  aspirin  and  clopidogrel. You  should  stick  to  the  option assigned  to  you  until  the  study  ends, unless  you  have  a  health  problem that  must  change  it. Continue  taking  your  usual  medicines. When  you  leave  hospital,  a  researcher will  add  information  to the  study  database  about medicines  that  you  are prescribed  and  how  you're  doing. If  you  join  aspiring, doctors  who  care  for  you  will  be  informed. Aspiring  will  store  information about  you  securely  and  confidentially. You  can  withdraw  from  part or  all  of  the  study  at  any  time, but  it  will  keep  the  information already  collected  about  you. Aspiring  will  follow  your  progress via  the  doctors  looking after  you  or  your  medical  records for  one  to  five  years. Ultimately,  Aspiring  will  analyse the  results  to  find  out whether  one  option  is  better  than  the  other, which  could  benefit  thousands  of brain  haemorrhage  survivors  around the  world  every  year. Thank  you  for  considering this  invitation  to  be  part  of  aspiring. Please  ask  if  you  have  any  questions. If  you've  met  the  study  team  at your  hospital,  please  ask  them. Otherwise,  contact the  team  coordinating  Aspiring. 

Stroke due to intracerebral haemorrhage (ICH) is a devastating cardiovascular disease that causes 48% of disability-adjusted life years due to stroke. ICH survivors are at high risk of further major adverse cardiovascular or cerebrovascular events (MACE, i.e. hospitalisation due to stroke [ischaemic or ICH], hospitalisation due to myocardial infarction, or cardiovascular death [by ischaemia, bleeding or other vascular causes]). In the REstart or STop Antithrombotics Randomised Trial (RESTART) of 537 people with cardiovascular diseases who survived ICH in the UK, starting antiplatelet drugs after ICH seemed safe and might have reduced MACE risk (Lancet 2019).

The Antiplatelet Secondary Prevention International Randomised study after INtracerebral haemorrhaGe (ASPIRING) aims to provide definitive evidence of the superiority of starting antiplatelet drug monotherapy compared with avoiding antiplatelet drugs in addition to standard care to prevent MACE for all ICH survivors.

It is an investigator-initiated, multicentre, pragmatic, prospective, randomised, parallel group, open (PROBE) clinical trial of an investigational medicinal product.  Further information on the ASPIRING trial can be found at www.aspiring.ed.ac.uk where you can register your interest and explore the project further.

An external pilot phase of ASPIRING in China and Australia completed in 2023 (more information can be found on the ASPIRING external pilot phase trial website).

The ASPIRING main phase has been funded via the Global Cardiovascular Research Funders Forum Multinational Clinical Trials Initiative and other funders, to recruit 4,148 participants 2024-2028 in the following countries:

Country   Funding agency        National leader

 

Australia

 

NHMRC MRFF

 

Graeme Hankey

 

Canada 

 

  CIHR

 

Ashkan Shoamanesh

 

The Netherlands

 

  Hartstichting

 

Karin Klijn

 

United Kingdom  

 

  BHF

 

Rustam Al-Shahi Salman

 

ASPIRING has regulatory approval in the UK from the Health Research Authority (Scotland A Research Ethics Committee ref. 24/SS/0056) and the MHRA.

ASPIRING was prospectively registered with the ISRCTN registry on 15 July 2024: ISRCTN16705062.