Reducing the Burden of Cardiovascular Events With Antiplatelet Therapy in Patients With IntraCerebral Haemorrhage
BEAT-ICH
1 other identifier
interventional
5,676
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2026
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 24, 2025
CompletedStudy Start
First participant enrolled
February 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 14, 2029
February 9, 2026
February 1, 2026
3 years
November 17, 2025
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Secondary Outcomes (3)
Major bleeding
3 years
Medication adherence
3 years (every 3 months) till study end
modified Rankin Scale
3 years (every 3 months) till study end
Study Arms (2)
Aspirin 75 mg OD
ACTIVE COMPARATORThe intervention is oral daily Aspirin 75 mg OD (antiplatelet drug monotherapy) in addition to standard care for secondary prevention after ICH based on the universal guidelines.
Placebo
PLACEBO COMPARATORThe control arm is placebo, which will be look-alike both as kits and tablets and will be prescribed in the same way as Aspirin: OD along with the standard secondary prevention after ICH.
Interventions
The 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.
The 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.
Eligibility Criteria
You may qualify if:
- 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
- Alive ≥24 hours after non-traumatic ICH
You may not qualify if:
- 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
- Enrolled in any other clinical trial
- Sick or compromised patients with life expectancy of less than a year
- Geographical or other factors that prohibit long-term follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indian Council of Medical Researchcollaborator
- Bangur Institute of Neurosciences Kolkatacollaborator
- Baptist Christian Hospital, Tezpur, Indiacollaborator
- Christian Medical College, Vellore, Indiacollaborator
- Lalitha Super Specialities Hospitalcollaborator
- PBM Hospital Bikaner, Indiacollaborator
- Christian Medical College and Hospital, Ludhiana, Indialead
- St. Stephen's Hospital, Delhicollaborator
- Amrita Institute of Medical Sciences & Research Centercollaborator
- Kasturba Medical Collegecollaborator
- Dr. Ramesh Cardiac and Multispecialty Hospital Guntur, Indiacollaborator
- Government General Hospital Guntur, Indiacollaborator
- Institute of Medical Sciences of the Banaras Hindu University, Indiacollaborator
- All India Institute of Medical Sciences, Bhubaneswarcollaborator
- KLE'S Dr Prabhakar Kore Hospital & MRC Balgaumcollaborator
- Guru Gobind Singh Medical College & Hospitalcollaborator
- Excelcare Hospitals Guwahaticollaborator
- Bharati Vidyapeeth DTU Medical College Pune, Indiacollaborator
- All India Institute of Medical Sciences, Bilaspurcollaborator
- KG Hospital and Post Graduate Medical Institute Coimbatore, Indiacollaborator
- Tirunelveli Medical College, Tirunelveli, Indiacollaborator
- Santokba Durlabhji Memorial Hospitalcollaborator
- Institute of Human Behaviour and Allied Sciences Delhicollaborator
- Government Medical College Trivandrum, Indiacollaborator
- Jaiswal Multispeciality Hospital And Neuro Institute, Kotacollaborator
- Shri Maharaja Hari Singh Hospitalcollaborator
- Government Medical College, Anantnag, Indiacollaborator
- Narayana Medical College & Hospitalcollaborator
- Renova Institute of Neurological Sciences (RINS); Renova Century Hospital Hyderabadcollaborator
- Rangaraya Medical Collegecollaborator
- All India Institute of Medical Sciences, Raebareli, UPcollaborator
- All India Institute of Medical Science, Patna, Bihar, Indiacollaborator
- Sri Balaji Institute of Medical Sciences, Raipur, Chhattisgarh, Indiacollaborator
- Manipal Group of Hospitals (Eastern Region), Kolkata, Indiacollaborator
- Sree Chitra Tirunal Institute for Medical Sciences & Technologycollaborator
- All India Institute of Medical Science, Guwahaticollaborator
- All India Institute of Medical Science, New Delhicollaborator
- King George's Medical University, Lucknow, Indiacollaborator
- P. D. Hinduja Hospital and Medical Research Centrecollaborator
- KIMS-SUNSHINE Hospital, Hyderabad, Indiacollaborator
- Sahyadri Superspeciality Hospital, Nasikcollaborator
- Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, Indiacollaborator
Study Sites (40)
Government General Hospital
Guntur, Andhra Pradesh, 522001, India
Lalitha Super Specialty Hospital
Guntur, Andhra Pradesh, 522001, India
Dr Ramesh Cardiac and Multispecialty Hospital
Guntur, Andhra Pradesh, 522004, India
Government General Hospital
Kākināda, Andhra Pradesh, 533003, India
Narayana Medical College and Hospital
Nellore, Andhra Pradesh, 524003, India
Apollo Excelcare Hospitals
Guwahati, Assam, 781033, India
Baptist Christian Hospital
Tezpur, Assam, 784001, India
All India Institute of Medical Science
Patna, Bihar, 801507, India
All India Institute of Medical Sciences
Bilāspur, Himachal Pradesh, 174001, India
Government Medical College
Anantnag, Jammu and Kashmir, 192101, India
Shri Maharaja Hari Singh (SMHS) Hospital
Srinagar, Jammu and Kashmir, 190010, India
Rajendra Institute of Medical Sciences
Ranchi, Jharkhand, 834009, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, Karnataka, 590010, India
Kasturba Medical College Manipal
Manipal, Karnataka, 576104, India
Amrita Institute for Medical Sciences and Research Center
Kochi, Kerala, 682041, India
Government Medical College Trivandrum
Thiruvananthapuram, Kerala, 695011, India
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, 695011, India
P. D. Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016, India
Sahyadri Superspeciality Hospital
Nashik, Maharashtra, 422001, India
Bharati Vidyapeeth DTU Medical College
Pune, Maharashtra, 411043, India
Institute of Human Behaviour and Allied Sciences
New Delhi, National Capital Territory of Delhi, 110095, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019, India
Guru Gobind Singh Medical College and Hospital
Farīdkot, Punjab, 151203, India
PBM Hospital
Bikaner, Rajasthan, 334001, India
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, 302015, India
Jaiswal Hospital and Neuro Institute
Kota, Rajasthan, 324005, India
KG Hospital and Post Graduate Medical Institute Coimbatore
Coimbatore, Tamil Nadu, 641018, India
Tirunelveli Medical College
Tirunelveli, Tamil Nadu, 627011, India
Christian Medical College Vellore
Vellore, Tamil Nadu, 632517, India
King George's Medical University
Lucknow, Uttar Pradesh, 226003, India
All India Institute of Medical Sciences
Raebareli, Uttar Pradesh, 229405, India
Institute of Medical Sciences of the Banaras Hindu University (BHU)
Varanasi, Uttar Pradesh, 221005, India
Bangur Institute of Neurosciences
Kolkata, West Bengal, 700020, India
St Stephen's Hospital
Delhi, 110054, India
All India Institute of Medical Science
Guwahati, 781101, India
KIMS-Sunshine Hospitals
Hyderabad, 500016, India
Renova Institute of Neurological Sciences (RINS); Renova Century Hospital
Hyderabad, 500034, India
Manipal Group of Hospitals (Eastern Region)
Kolkata, 700017, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, 226014, India
All India Institute of Medical Science
New Delhi, 110029, India
Related Publications (4)
RESTART Collaboration. Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial. Lancet. 2019 Jun 29;393(10191):2613-2623. doi: 10.1016/S0140-6736(19)30840-2. Epub 2019 May 22.
PMID: 31128924BACKGROUNDWong YS, Tsai CF, Ong CT. Risk factors for stroke recurrence in patients with hemorrhagic stroke. Sci Rep. 2022 Oct 13;12(1):17151. doi: 10.1038/s41598-022-22090-7.
PMID: 36229641BACKGROUNDKatan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.
PMID: 29791947BACKGROUNDBanerjee TK, Das SK. Fifty years of stroke researches in India. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):1-8. doi: 10.4103/0972-2327.168631.
PMID: 27011621BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeyaraj D Pandian, MD, DM
Christian Medical College and Hospital, Ludhiana, Punjab, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal and Professor, Department of Neurology
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 24, 2025
Study Start
February 15, 2026
Primary Completion (Estimated)
February 14, 2029
Study Completion (Estimated)
February 14, 2029
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana, Punjab, India. Participants information will be identified only by their initials and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password-protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as metaanalyses, reanalysis, or replication of results.