Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07243704

Reducing the Burden of Cardiovascular Events With Antiplatelet Therapy in Patients With IntraCerebral Haemorrhage

Conditions: Intracerebral Haemorrhage

Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 5676
Sponsor: Christian Medical College and Hospital, Ludhiana, India

Location: Government General Hospital Guntur Andhra Pradesh

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07243704). StuddyBuddy aggregates publicly available trial information.