Reducing the Burden of Cardiovascular Events with Antiplatelet Therapy in Patients with Intracerebral Haemorrhage: BEAT-ICH India
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 5,676
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •first-ever ICH patients age more than 18 years presenting more than 24 hrs of the onset of stroke symptoms confirmed by brain imaging
- •alive more than 24 hours after non-traumatic ICH
- •not taking antiplatelet therapy or therapeutic dose anticoagulant therapy when randomised.
- •Consent obtained from the patient or legally accepted representative.
Exclusion Criteria
- •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
- •Volume of hematoma more than 60 ml
- •Glasgow comma scale less than equal to 5
- •they are pregnant, breastfeeding, or of childbearing potential and not using contraception
- •They are enrolled in a study that precludes co-enrolment
- •Sick or compromised patients
- •Geographical or other factors that prohibit follow-up.
Outcomes
Primary Outcomes
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)
Time Frame: End of the trial
Secondary Outcomes
- 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)
Investigators
Dr Jeyaraj D Pandian
Christian Medical College and Hospital, Ludhiana