A Phase 3 interventional study of Aspirin 75 mg daily and Placebo in Intracerebral Haemorrhage, sponsored by Christian Medical College and Hospital, Ludhiana, India. Recruiting at 33 sites in India. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Christian Medical College and Hospital, Ludhiana, India · Phase 3, Interventional, and Treatment
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.
Stroke is the second leading cause of death and disability globally. Intracerebral haemorrhage (ICH) accounts for 10% to 15% of strokes in high-income countries and 20% to 50% in developing countries. The proportion of ICH ranges from 19% to 41% in India and is higher in Eastern India. Recurrent stroke rates are high worldwide; 15% in India (Kolkata), 41% in China, 6 and 13% in Taiwan.
ICH patients are at a risk of recurrent stroke (ICH and ischaemic) and other serious cardiovascular events, and yet there is no consensus regarding starting antiplatelet drugs for secondary prevention. RESTART is the only trial (pilot) that studied antiplatelet therapy and showed a decrease in recurrent ICH compared to no antiplatelet therapy, with a median follow-up of 2 years (IQR [1·0-3·0]). The recurrence rates were 4% in the intervention group versus 9% in the control group. There is no large stroke trial which has addressed this question.
Hence, plan is to initiate the BEAT-ICH trial, a randomized placebo-controlled trial of ICH patients where intervention arm patients will receive antiplatelet monotherapy (Aspirin 75mg) and the control arm will receive a placebo. The primary outcome will be determining whether antiplatelet monotherapy provides a net reduction in major adverse cardiovascular and cerebrovascular events (MACE) in the long term in ICH patients.
Trial Population:
This multi-centric study will be conducted at 50 stroke centres in India associated with the INSTRuCT Network. All patients presenting with symptoms of stroke to the hospital and admitted to the stroke units will be screened for eligibility and if met, will be included in the study. The BEAT ICH trial intends to recruit 5676 patients.
Study design:
Each site will have a team of neurologists (Principal Investigator and Co-Investigators) and a site coordinator. All ICH patients admitted to stroke and neurology wards, Outpatient department (OPD) or Inpatient Department (IPD) after 24 hrs to 3 months will be screened for eligibility by the image-conformed haemorrhagic stroke by the site neurologist.
Investigators will collect complete information about patients' demographics, comorbidities, functional status (US National Institutes of Health Stroke Scale score (NIHSS) and the modified Rankin Scale mRS)), previous antithrombotic therapy, medical history, medication history (at the time of stroke and at the time of randomisation), and intracerebral haemorrhage (image confirmed), vitals and assessments and hematoma details into a database via a secure web interface with in-built validation to ensure complete baseline data before randomisation.
Each patient will undergo brain imaging by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as part of routine care at the time of ICH before enrolment. In case of any events, a second CT/MRI scan will be performed to assess for haematoma. All images will be saved in Digital Imaging and Communications in Medicine (DICOM) format and uploaded to the trial's Picture Archiving and Communication System (PACS) server.
After obtaining the consent form, Data will initially be recorded on paper case record forms (pCRF) and later entered into the electronic database. Patients not meeting the trial's eligibility criteria (screen failures) will also be captured in the database. All the recruited patients will be covered under comprehensive insurance for the entire trial duration. Randomisation will be initiated ≥24 hours after ICH onset up to 3 months, provided ICH growth has stopped by 24 hours after onset, followed by the investigational product (Aspirin/placebo) for the entire trial duration. All patients will receive additional standard care as per current gulidelines along with the intervention. Patients in the intervention arm will receive Aspirin 75 mg daily, and the control arm will receive a placebo tablet of similar shape, size, and colour daily. Both investigational products will be pills that look similar in appearance. Pharmaceutical company will centrally manufacture, label, and dispense the investigational products under the supervision of the pharmacologist at Christian Medical College and Hospital (CMCL). Since this trial is triple-blinded, the investigator, coordinator, and patient will be blinded to the allocated study treatment. Only the pharmacologist will decode in case of an event requiring a medication change in an emergency.
Each site will have a stock for a duration of one year, with new investigational products delivered yearly or based on prior consumption and follow-up requirements. Each site is expected to have a dedicated IP room for this purpose. Once delivered, the site will handle the storage, dispensing, and destruction of the investigational products, unused IP, and returned kits under the hospital's waste disposal management protocols with strict supervision.
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 total 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.
All patients will remain in the trial until the end of the study period (3 years to the max)/event/death/withdrawal. If a patient develops an event, the investigational product will be stopped, and treatment will be initiated based on the event and clinical guidelines. Unused investigational products will be returned to the site. If required, the trial pharmacologist will handle decoding after an event. Site research staff will capture all event-related data and submit it to the database and the site ethics committee for review. The central independent event adjudication committee will also review this data. In case of patient withdrawal or death, the investigational product will also be returned to the site. All patients will be analysed using the intention-to-treat principle, even if they withdraw at any point during the trial.
Patients will be called for face-to-face visits every 3 months to dispense the investigational product. Kits will be labelled as BEAT-ICH trial medication, with a unique kit number for identification for each patient. Each kit will contain 100 tablets, including a buffer of 10 tablets for delayed visits/buffer dose. The site coordinators will call the patient 15 days before the visit as a reminder to come to the hospital to take the next batch of IP. Monthly telephonic follow-ups will ensure medication adherence and detect events. Patients will be encouraged to report events during the interim follow-up period. At each visit, patients will return used kits and unused medication (expected return of approximately 10 tablets on every three-month visit) to monitor medication adherence.
The need for this study:
The BEAT-ICH trial has the potential to reduce the recurrent stroke rate and MACE after ICH. In addition, this trial will address the important question of the safety of antiplatelet use in ICH patients. If completed, this trial can change Clinical practice and guidelines globally, as aspirin is a low-cost drug that can be provided at all levels of healthcare in India.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's planned enrollment of 5,676 is above the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →Christian Medical College and Hospital, Ludhiana, India is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The 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.
Drug: Aspirin 75 mg daily
The 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.
Drug: Placebo
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.
Also known as: Aspirin
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.
Also known as: Placebo OD
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.
Time frame: 3 years
Major bleeding
To study the safety composite outcome of major bleeding (all major haemorrhagic events that are fatal or result in hospitalisation)
Time frame: 3 years
Medication adherence
To check the adherence of aspirin vs placebo.
Time frame: 3 years (every 3 months) till study end
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.
Time frame: 3 years (every 3 months) till study end
Plan to share: No — 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.
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Studies of the drug tested here: Aspirin
Christian Medical College and Hospital, Ludhiana, India