| CTRI Number |
CTRI/2025/06/088193 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Reducing brain and heart events after brain hemorrhage with Aspirin tablet: BEAT-ICH India |
|
Scientific Title of Study
|
Reducing the Burden of Cardiovascular Events with Antiplatelet Therapy in Patients with Intracerebral Haemorrhage: BEAT-ICH India |
| Trial Acronym |
BEAT-ICH India |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
Principal and Professor |
| Affiliation |
Christian Medical College and Hospital, Ludhiana |
| Address |
Room number 2, Department of Neurology behind Radiology department, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
Principal Investigator |
| Affiliation |
Christian Medical College and Hospital, Ludhiana |
| Address |
Room number 2, Department of Neurology behind Radiology department, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeyaraj D Pandian |
| Designation |
Principal Investigator |
| Affiliation |
Christian Medical College and Hospital, Ludhiana |
| Address |
Room number 2, Department of Neurology behind Radiology department, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
Ludhiana
PUNJAB
141008
India |
| Phone |
9915784750 |
| Fax |
|
| Email |
jeyarajpandian@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi
|
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research, New Delhi |
| Address |
Indian Council of Medical Research, New Delhi, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeyaraj D Pandian |
Christian Medical College and Hospital, Ludhiana |
Room number 2, Department of Neurology behind Radiology department, Christian Medical College and Hospital, Brown Road, Ludhiana, Punjab
Ludhiana
PUNJAB |
9915784750
jeyarajpandian@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 26 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee Varanasi |
Approved |
| BIOETHICS CELL ALL INDIA INSITUTE OF MEDICAL SCIENCES RAEBARELI |
Approved |
| Emmanuel Hospital Association Institutional Ethics Committee |
Approved |
| Ethics Committee Bhargavi Healthcare Services Private Limited (RINS) |
Approved |
| Ethics Committee Guntur Medical College and Govt. General Hospital |
Approved |
| ETHICS COMMITTEE RELATING TO BIOMEDICAL HEALTH RESEARCH, NARAYANA MEDICAL COLLEGE AND HOSPITAL |
Approved |
| Ethics Committee Sardar Patel Medical College Bikaner |
Approved |
| Guru Gobind Singh Medical College, Faridkot, Punjab, Institutional Ethics Committee |
Approved |
| IEC AIIMS Bhubaneswar |
Approved |
| INSTITUTE ETHICS COMMITTEE St. Stephens Hospital, Tis Hazari, Delhi |
Approved |
| Institute Ethics Committee, AIIMS New Delhi |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS PATNA |
Approved |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed University |
Approved |
| Institutional Ethics Committee CMC Ludhiana |
Approved |
| Institutional Ethics Committee Dr Ramesh Cardiac and Multispeciality Hospital P Ltd. |
Approved |
| Institutional Ethics Committee IHBAS, Delhi |
Approved |
| Institutional Ethics Committee P.D. Hinduja Hopsital and Medical research centre |
Approved |
| Institutional Ethics Committee Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum |
Approved |
| Institutional Ethics Committee, KG Hospital |
Approved |
| IPGME&R Research Oversight Committee (Institutional Ethics Committee for Clinical Research) |
Approved |
| KIMS Ethics Committee |
Approved |
| King Georges Medical University, U.P., Lucknow, Institutional Ethics Committee |
Approved |
| Lalitha Super Specialties Hospital Ethics Committee |
Approved |
| Radha Krishna critical care and general hospital kota institutional Ethics Committee |
Approved |
| rangaraya medical college Institutional ethics committee |
Approved |
| Shri Balaji Institute of Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G810||Flaccid hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aspirin 75mg |
Aspirin will be initiated after randomization after 24 hours after ICH onset up to 3 months, provided ICH growth has stopped by 24 hours after onset, followed by the Aspirin for the entire trial duration. |
| Comparator Agent |
Placebo |
A placebo will be initiated after randomization after 24 hours after ICH onset up to 3 months, provided ICH growth has stopped by 24 hours after onset, followed by the placebo for the entire trial duration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. first-ever ICH patients age more than 18 years presenting more than 24 hrs of the onset of stroke symptoms confirmed by brain imaging
2. alive more than 24 hours after non-traumatic ICH
3. not taking antiplatelet therapy or therapeutic dose anticoagulant therapy when randomised.
4. Consent obtained from the patient or legally accepted representative
|
|
| ExclusionCriteria |
| Details |
1. ICH is known to be due to trauma, a structural cause, for example, aneurysm, arteriovenous malformation, cerebral cavernous malformation, venous thrombosis, tumor, or hemorrhagic transformation of cerebral infarction
2. Volume of hematoma more than 60 ml
3. Glasgow comma scale less than equal to 5
4. they are pregnant, breastfeeding, or of childbearing potential and not using contraception
5. They are enrolled in a study that precludes co-enrolment
6. Sick or compromised patients
7. Geographical or other factors that prohibit follow-up
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to assess the efficacy of composite of all MACE: stroke, myocardial infarction, or death from any vascular cause (also including sudden death, pulmonary embolism, haemorrhage, and death from an unknown cause)
|
End of the trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome (safety) is major bleeding (all major haemorrhagic events that are fatal or result in hospitalisation), medication adherence and mRS (modified Rankin Scale) |
End of the trial |
|
|
Target Sample Size
|
Total Sample Size="5676"
Sample Size from India="5676"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the BEAT-ICH Trial, we aim
to reduce the risk of MACE with
antiplatelet monotherapy in ICH patients.
It will be a three-year
pragmatic, randomised, blinded, superiority clinical trial aiming to recruit
patients over 18 years who survive ICH and assign them to starting antiplatelet
monotherapy Aspirin 75 mg od versus placebo for preventing MACE.
All the first-ever ICH (non-traumatic)
patients aged 18 years and above presenting more than equal to 24 hrs of the
onset of stroke symptoms confirmed by brain imaging; alive more than equal to 24
hours after non-traumatic with ICH volume of hematoma less than 60 ml and
Glasgow comma scale less than equal to 5 will be recruited. The primary outcome
is to assess the efficacy of a composite of all MACE.
The duration of medication and
follow-up will depend on the recruitment timeline. Patients recruited during
the first year of the trial will take the medication for three years or until
the trial ends or an event occurs, with a matching follow-up period. The total
recruitment period will last 2.5 years, with a corresponding follow-up period,
ensuring that the last patient recruited will participate for at least six
months for both medication and follow-up. |