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NCT07243704
PHASE3

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

Sponsor: Christian Medical College and Hospital, Ludhiana, India

View on ClinicalTrials.gov

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.

Official title: Reducing the Burden of Cardiovascular Events With Antiplatelet Therapy in Patients With IntraCerebral Haemorrhage.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

5676

Start Date

2026-02-15

Completion Date

2029-02-14

Last Updated

2026-02-09

Healthy Volunteers

No

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.

Locations (40)

Government General Hospital

Guntur, Andhra Pradesh, India

Lalitha Super Specialty Hospital

Guntur, Andhra Pradesh, India

Dr Ramesh Cardiac and Multispecialty Hospital

Guntur, Andhra Pradesh, India

Government General Hospital

Kākināda, Andhra Pradesh, India

Narayana Medical College and Hospital

Nellore, Andhra Pradesh, India

Apollo Excelcare Hospitals

Guwahati, Assam, India

Baptist Christian Hospital

Tezpur, Assam, India

All India Institute of Medical Science

Patna, Bihar, India

All India Institute of Medical Sciences

Bilāspur, Himachal Pradesh, India

Government Medical College

Anantnag, Jammu and Kashmir, India

Shri Maharaja Hari Singh (SMHS) Hospital

Srinagar, Jammu and Kashmir, India

Rajendra Institute of Medical Sciences

Ranchi, Jharkhand, India

KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, India

Kasturba Medical College Manipal

Manipal, Karnataka, India

Amrita Institute for Medical Sciences and Research Center

Kochi, Kerala, India

Government Medical College Trivandrum

Thiruvananthapuram, Kerala, India

Sree Chitra Tirunal Institute for Medical Sciences and Technology

Thiruvananthapuram, Kerala, India

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, India

Sahyadri Superspeciality Hospital

Nashik, Maharashtra, India

Bharati Vidyapeeth DTU Medical College

Pune, Maharashtra, India

Institute of Human Behaviour and Allied Sciences

New Delhi, National Capital Territory of Delhi, India

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India

Guru Gobind Singh Medical College and Hospital

Farīdkot, Punjab, India

PBM Hospital

Bikaner, Rajasthan, India

Santokba Durlabhji Memorial Hospital

Jaipur, Rajasthan, India

Jaiswal Hospital and Neuro Institute

Kota, Rajasthan, India

KG Hospital and Post Graduate Medical Institute Coimbatore

Coimbatore, Tamil Nadu, India

Tirunelveli Medical College

Tirunelveli, Tamil Nadu, India

Christian Medical College Vellore

Vellore, Tamil Nadu, India

King George's Medical University

Lucknow, Uttar Pradesh, India

All India Institute of Medical Sciences

Raebareli, Uttar Pradesh, India

Institute of Medical Sciences of the Banaras Hindu University (BHU)

Varanasi, Uttar Pradesh, India

Bangur Institute of Neurosciences

Kolkata, West Bengal, India

St Stephen's Hospital

Delhi, India

All India Institute of Medical Science

Guwahati, India

KIMS-Sunshine Hospitals

Hyderabad, India

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

Hyderabad, India

Manipal Group of Hospitals (Eastern Region)

Kolkata, India

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, India

All India Institute of Medical Science

New Delhi, India