drugset / Trial / NCT07243704

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

NCT07243704 ↗

Phase 3 Not yet recruiting 5676 enrolled Christian Medical College and Hospital, Ludhiana, India All India Institute of Medical Science, Guwahati · collabAll India Institute of Medical Science, New Delhi · collabAll India Institute of Medical Science, Patna, Bihar, India · collabAll India Institute of Medical Sciences, Bhubaneswar · collabAll India Institute of Medical Sciences, Bilaspur · collabAll India Institute of Medical Sciences, Raebareli, UP · collabAmrita Institute of Medical Sciences & Research Center · collabBangur Institute of Neurosciences Kolkata · collabBaptist Christian Hospital, Tezpur, India · collabBharati Vidyapeeth DTU Medical College Pune, India · collabChristian Medical College, Vellore, India · collabDr. Ramesh Cardiac and Multispecialty Hospital Guntur, India · collabExcelcare Hospitals Guwahati · collabGovernment General Hospital Guntur, India · collabGovernment Medical College Trivandrum, India · collabGovernment Medical College, Anantnag, India · collabGuru Gobind Singh Medical College & Hospital · collabIndian Council of Medical Research · collabInstitute of Human Behaviour and Allied Sciences Delhi · collabInstitute of Medical Sciences of the Banaras Hindu University, India · collabJaiswal Multispeciality Hospital And Neuro Institute, Kota · collabKG Hospital and Post Graduate Medical Institute Coimbatore, India · collabKIMS-SUNSHINE Hospital, Hyderabad, India · collabKLE'S Dr Prabhakar Kore Hospital & MRC Balgaum · collabKasturba Medical College · collabKing George's Medical University, Lucknow, India · collabLalitha Super Specialities Hospital · collabManipal Group of Hospitals (Eastern Region), Kolkata, India · collabNarayana Medical College & Hospital · collabP. D. Hinduja Hospital and Medical Research Centre · collabPBM Hospital Bikaner, India · collabRajendra Institute of Medical Sciences, Ranchi, Jharkhand, India · collabRangaraya Medical College · collabRenova Institute of Neurological Sciences (RINS); Renova Century Hospital Hyderabad · collabSahyadri Superspeciality Hospital, Nasik · collabSantokba Durlabhji Memorial Hospital · collabShri Maharaja Hari Singh Hospital · collabSree Chitra Tirunal Institute for Medical Sciences & Technology · collabSri Balaji Institute of Medical Sciences, Raipur, Chhattisgarh, India · collabSt. Stephen's Hospital, Delhi · collabTirunelveli Medical College, Tirunelveli, India · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-02-15
Primary completion
2029-02-14
Completion
2029-02-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 75 mg Oral