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

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.

Conditions

• Intracerebral Haemorrhage

Interventions

DRUG

Aspirin 75 mg daily

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• Indian Council of Medical Research

  collaborator OTHER_GOV

• St. Stephen's Hospital, Delhi

  collaborator OTHER

• Amrita Institute of Medical Sciences & Research Center

  collaborator OTHER

• Kasturba Medical College

  collaborator OTHER

• Bangur Institute of Neurosciences Kolkata

  collaborator UNKNOWN

• Baptist Christian Hospital, Tezpur, India

  collaborator UNKNOWN

• Christian Medical College, Vellore, India

  collaborator OTHER

• Lalitha Super Specialities Hospital

  collaborator OTHER

• Dr. Ramesh Cardiac and Multispecialty Hospital Guntur, India

  collaborator UNKNOWN

• Government General Hospital Guntur, India

  collaborator UNKNOWN

• Institute of Medical Sciences of the Banaras Hindu University, India

  collaborator OTHER

• All India Institute of Medical Sciences, Bhubaneswar

  collaborator OTHER

• KLE'S Dr Prabhakar Kore Hospital & MRC Balgaum

  collaborator UNKNOWN

• Guru Gobind Singh Medical College & Hospital

  collaborator OTHER

• PBM Hospital Bikaner, India

  collaborator UNKNOWN

• Excelcare Hospitals Guwahati

  collaborator UNKNOWN

• Bharati Vidyapeeth DTU Medical College Pune, India

  collaborator UNKNOWN

• All India Institute of Medical Sciences, Bilaspur

  collaborator UNKNOWN

• KG Hospital and Post Graduate Medical Institute Coimbatore, India

  collaborator UNKNOWN

• Tirunelveli Medical College, Tirunelveli, India

  collaborator UNKNOWN

• Santokba Durlabhji Memorial Hospital

  collaborator OTHER

• Institute of Human Behaviour and Allied Sciences Delhi

  collaborator UNKNOWN

• Government Medical College Trivandrum, India

  collaborator UNKNOWN

• Jaiswal Multispeciality Hospital And Neuro Institute, Kota

  collaborator UNKNOWN

• Shri Maharaja Hari Singh Hospital

  collaborator OTHER_GOV

• Government Medical College, Anantnag, India

  collaborator UNKNOWN

• Narayana Medical College & Hospital

  collaborator OTHER

• Renova Institute of Neurological Sciences (RINS); Renova Century Hospital Hyderabad

  collaborator UNKNOWN

• Rangaraya Medical College

  collaborator OTHER

• All India Institute of Medical Sciences, Raebareli, UP

  collaborator UNKNOWN

• All India Institute of Medical Science, Patna, Bihar, India

  collaborator UNKNOWN

• Sri Balaji Institute of Medical Sciences, Raipur, Chhattisgarh, India

  collaborator UNKNOWN

• Manipal Group of Hospitals (Eastern Region), Kolkata, India

  collaborator UNKNOWN

• Sree Chitra Tirunal Institute for Medical Sciences & Technology

  collaborator OTHER_GOV

• All India Institute of Medical Science, Guwahati

  collaborator UNKNOWN

• All India Institute of Medical Science, New Delhi

  collaborator UNKNOWN

• King George's Medical University, Lucknow, India

  collaborator UNKNOWN

• P. D. Hinduja Hospital and Medical Research Centre

  collaborator UNKNOWN

• KIMS-SUNSHINE Hospital, Hyderabad, India

  collaborator UNKNOWN

• Sahyadri Superspeciality Hospital, Nasik

  collaborator UNKNOWN

• Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India

  collaborator UNKNOWN

• Christian Medical College and Hospital, Ludhiana, India

  lead OTHER

Principal Investigators

• Jeyaraj D Pandian, MD, DM · Christian Medical College and Hospital, Ludhiana, Punjab, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-15

Primary Completion

2029-02-14

Completion

2029-02-14

Countries

• India

Study Locations