BEAT ICH will be a pragmatic, randomised, placebo-controlled, blinded, superiority clinical trial aiming to recruit 5676 patients aged ≥18 years who survive ICH and assign them 1:1 to starting antiplatelet monotherapy (Aspirin 75 mg od) versus placebo for the entire duration of the trial for preventing MACE. Recruitment duration is for 2.5 years. The duration of the medication and follow-up will vary based on recruitment timeline. If recruited during the first year of the trial, the patient will take the medication for three years or until the trial ends or an event occurs, with a matching follow-up period. If recruited towards the end of the trial, he/she will take the medication for six months and be followed up for the same duration. The trial's follow-up duration is three years. The patients will be recruited for 2.5 years, and the last recruit will have a minimum follow-up of six months. No new patients will be recruited within the last six months of the trial, but all the patients will be followed up until the end of the trial.
Age ≥18 years
First-ever Intracerebral Haemorrhage
Presenting ≥24 hrs up to 3 months of stroke symptoms confirmed by brain imaging
CT /MRI confirming Intracerebral Haemorrhage
ICH is known to be due to trauma, a structural cause (e.g., aneurysm, arteriovenous malformation, cerebral cavernous malformation, venous thrombosis, or tumour), or haemorrhagic transformation of cerebral infarction
Glasgow coma score ≤5
Taking any antiplatelet or anticoagulant therapy 15 days prior to randomization.
Women pregnant, breastfeeding, childbearing potential, and not using contraceptives
Parallel
Aspirin 75 mg daily
DrugThe intervention is oral daily Aspirin 75 mg OD The duration of the medication and follow-up will vary based on the recruitment timeline. If recruited during the first year of the trial, the first patient will take the medication for 2.5 years, and the last patient will get the IP for a minimum of 6 months.
Placebo
DrugThe intervention is a placebo to be taken OD. The duration of the placebo and follow-up will vary based on the recruitment timeline. If recruited during the first year of the trial, the first patient will take the placebo for 2.5 years, and the last patient will get the placebo for a minimum of 6 months.
Major Adverse Cardiovascular Events (MACE)
To reduce the risk of first MACE (stroke, myocardial infarction, hospitalisation, or death) with antiplatelet monotherapy in ICH patients. The components of the MACE include ischemic stroke, haemorrhagic stroke, hospitalisation due to stroke (ischemic, haemorrhagic, subarachnoid haemorrhage), myocardial infarction, coronary artery disease, cerebral and cardiovascular death due to any vascular causes (including pulmonary embolism, gastrointestinal haemorrhage) or death due to non-Cerebrovascular and cardiovascular causes.
Major bleeding
To study the safety composite outcome of major bleeding (all major haemorrhagic events that are fatal or result in hospitalisation)
Medication adherence
To check the adherence of aspirin vs placebo.
modified Rankin Scale
To check the modified Rankin Scale (mRS), a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a ICH stroke.
Click on the lead sponsor to view all of their trials.
Christian Medical College and Hospital, Ludhiana, India
Lead sponsor
Indian Council of Medical Research
Collaborator
St. Stephen's Hospital, Delhi
Collaborator
Amrita Institute of Medical Sciences & Research Center
Collaborator
Bangur Institute of Neurosciences Kolkata
Collaborator
Baptist Christian Hospital, Tezpur, India
Collaborator
Christian Medical College, Vellore, India
Collaborator
Lalitha Super Specialities Hospital
Collaborator
Dr. Ramesh Cardiac and Multispecialty Hospital Guntur, India
Collaborator
Government General Hospital Guntur, India
Collaborator
Institute of Medical Sciences of the Banaras Hindu University, India
Collaborator
All India Institute of Medical Sciences, Bhubaneswar
Collaborator
KLE'S Dr Prabhakar Kore Hospital & MRC Balgaum
Collaborator
Guru Gobind Singh Medical College & Hospital
Collaborator
PBM Hospital Bikaner, India
Collaborator
Excelcare Hospitals Guwahati
Collaborator
Bharati Vidyapeeth DTU Medical College Pune, India
Collaborator
KG Hospital and Post Graduate Medical Institute Coimbatore, India
Collaborator
Santokba Durlabhji Memorial Hospital
Collaborator
Institute of Human Behaviour and Allied Sciences Delhi
Collaborator
Government Medical College Trivandrum, India
Collaborator
Jaiswal Multispeciality Hospital And Neuro Institute, Kota
Collaborator
Narayana Medical College & Hospital
Collaborator
Renova Institute of Neurological Sciences (RINS); Renova Century Hospital Hyderabad
Collaborator
Rangaraya Medical College
Collaborator
All India Institute of Medical Science, Raebareli
Collaborator
All India Institute of Medical Science, Patna, Bihar, India
Collaborator
Sri Balaji Institute of Medical Sciences, Raipur, Chhattisgarh, India
Collaborator
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Collaborator
All India Institute of Medical Science, Guwahati
Collaborator
All India Institute of Medical Science, New Delhi
Collaborator
P. D. Hinduja Hospital and Medical Research Centre
Collaborator
KIMS-SUNSHINE Hospital, Hyderabad, India
Collaborator
Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India
Collaborator
King George's Medical University
Collaborator
