NCT07243704 Reducing the Burden of Cardiovascular Events With Antiplatelet Therapy in Patients With IntraCerebral Haemorrhage
| NCT ID | NCT07243704 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Christian Medical College and Hospital, Ludhiana, India |
| Condition | Intracerebral Haemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,676 participants |
| Start Date | 2026-02-16 |
| Primary Completion | 2029-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 5,676 participants in total. It began in 2026-02-16 with a primary completion date of 2029-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 & Investigator
Jeyaraj D Pandian, MD, DM
PRINCIPAL INVESTIGATOR
Christian Medical College and Hospital, Ludhiana, Punjab, India
Frequently Asked Questions
Who can join the NCT07243704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Intracerebral Haemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07243704 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 5,676 participants.
Is NCT07243704 currently recruiting?
Yes, NCT07243704 is actively recruiting participants. Contact the research team at jeyarajpandian@hotmail.com for enrollment information.
Where is the NCT07243704 trial being conducted?
This trial is being conducted at Guntur, India, Guntur, India, Guntur, India, Kākināda, India and 11 additional locations.
Who is sponsoring the NCT07243704 clinical trial?
NCT07243704 is sponsored by Christian Medical College and Hospital, Ludhiana, India. The principal investigator is Jeyaraj D Pandian, MD, DM at Christian Medical College and Hospital, Ludhiana, Punjab, India. The trial plans to enroll 5,676 participants.