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Reduzir o Fardo de Eventos Cardiovasculares com Terapia Antiplaquetária em Doentes com Hemorragia Intracerebral (BEAT-ICH)

21 de setembro de 2026 atualizado por: Jeyaraj D Pandian, Christian Medical College and Hospital, Ludhiana, India

Reduzir o Fardo dos Eventos Cardiovasculares com Terapia Antiplaquetária em Doentes com Hemorragia Intracerebral.

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Stroke is the second leading cause of death and disability globally. Intracerebral haemorrhage (ICH) accounts for 10% to 15% of strokes in high-income countries and 20% to 50% in developing countries. The proportion of ICH ranges from 19% to 41% in India and is higher in Eastern India. Recurrent stroke rates are high worldwide; 15% in India (Kolkata), 41% in China, 6 and 13% in Taiwan.

ICH patients are at a risk of recurrent stroke (ICH and ischaemic) and other serious cardiovascular events, and yet there is no consensus regarding starting antiplatelet drugs for secondary prevention. RESTART is the only trial (pilot) that studied antiplatelet therapy and showed a decrease in recurrent ICH compared to no antiplatelet therapy, with a median follow-up of 2 years (IQR [1·0-3·0]). The recurrence rates were 4% in the intervention group versus 9% in the control group. There is no large stroke trial which has addressed this question.

Hence, plan is to initiate the BEAT-ICH trial, a randomized placebo-controlled trial of ICH patients where intervention arm patients will receive antiplatelet monotherapy (Aspirin 75mg) and the control arm will receive a placebo. The primary outcome will be determining whether antiplatelet monotherapy provides a net reduction in major adverse cardiovascular and cerebrovascular events (MACE) in the long term in ICH patients.

Trial Population:

This multi-centric study will be conducted at 50 stroke centres in India associated with the INSTRuCT Network. All patients presenting with symptoms of stroke to the hospital and admitted to the stroke units will be screened for eligibility and if met, will be included in the study. The BEAT ICH trial intends to recruit 5676 patients.

Study design:

Each site will have a team of neurologists (Principal Investigator and Co-Investigators) and a site coordinator. All ICH patients admitted to stroke and neurology wards, Outpatient department (OPD) or Inpatient Department (IPD) after 24 hrs to 3 months will be screened for eligibility by the image-conformed haemorrhagic stroke by the site neurologist.

Investigators will collect complete information about patients' demographics, comorbidities, functional status (US National Institutes of Health Stroke Scale score (NIHSS) and the modified Rankin Scale mRS)), previous antithrombotic therapy, medical history, medication history (at the time of stroke and at the time of randomisation), and intracerebral haemorrhage (image confirmed), vitals and assessments and hematoma details into a database via a secure web interface with in-built validation to ensure complete baseline data before randomisation.

Each patient will undergo brain imaging by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as part of routine care at the time of ICH before enrolment. In case of any events, a second CT/MRI scan will be performed to assess for haematoma. All images will be saved in Digital Imaging and Communications in Medicine (DICOM) format and uploaded to the trial's Picture Archiving and Communication System (PACS) server.

After obtaining the consent form, Data will initially be recorded on paper case record forms (pCRF) and later entered into the electronic database. Patients not meeting the trial's eligibility criteria (screen failures) will also be captured in the database. All the recruited patients will be covered under comprehensive insurance for the entire trial duration. Randomisation will be initiated ≥24 hours after ICH onset up to 3 months, provided ICH growth has stopped by 24 hours after onset, followed by the investigational product (Aspirin/placebo) for the entire trial duration. All patients will receive additional standard care as per current gulidelines along with the intervention. Patients in the intervention arm will receive Aspirin 75 mg daily, and the control arm will receive a placebo tablet of similar shape, size, and colour daily. Both investigational products will be pills that look similar in appearance. Pharmaceutical company will centrally manufacture, label, and dispense the investigational products under the supervision of the pharmacologist at Christian Medical College and Hospital (CMCL). Since this trial is triple-blinded, the investigator, coordinator, and patient will be blinded to the allocated study treatment. Only the pharmacologist will decode in case of an event requiring a medication change in an emergency.

Each site will have a stock for a duration of one year, with new investigational products delivered yearly or based on prior consumption and follow-up requirements. Each site is expected to have a dedicated IP room for this purpose. Once delivered, the site will handle the storage, dispensing, and destruction of the investigational products, unused IP, and returned kits under the hospital's waste disposal management protocols with strict supervision.

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 total 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.

All patients will remain in the trial until the end of the study period (3 years to the max)/event/death/withdrawal. If a patient develops an event, the investigational product will be stopped, and treatment will be initiated based on the event and clinical guidelines. Unused investigational products will be returned to the site. If required, the trial pharmacologist will handle decoding after an event. Site research staff will capture all event-related data and submit it to the database and the site ethics committee for review. The central independent event adjudication committee will also review this data. In case of patient withdrawal or death, the investigational product will also be returned to the site. All patients will be analysed using the intention-to-treat principle, even if they withdraw at any point during the trial.

Patients will be called for face-to-face visits every 3 months to dispense the investigational product. Kits will be labelled as BEAT-ICH trial medication, with a unique kit number for identification for each patient. Each kit will contain 100 tablets, including a buffer of 10 tablets for delayed visits/buffer dose. The site coordinators will call the patient 15 days before the visit as a reminder to come to the hospital to take the next batch of IP. Monthly telephonic follow-ups will ensure medication adherence and detect events. Patients will be encouraged to report events during the interim follow-up period. At each visit, patients will return used kits and unused medication (expected return of approximately 10 tablets on every three-month visit) to monitor medication adherence.

The need for this study:

The BEAT-ICH trial has the potential to reduce the recurrent stroke rate and MACE after ICH. In addition, this trial will address the important question of the safety of antiplatelet use in ICH patients. If completed, this trial can change Clinical practice and guidelines globally, as aspirin is a low-cost drug that can be provided at all levels of healthcare in India.

Tipo de estudo

Intervencional

Inscrição (Estimado)

5676

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Índia
      • Delhi, Índia, 110054
        • Recrutamento
        • St Stephen's Hospital
        • Contato:
        • Investigador principal:
          • Gaurav K Mittal, MD DM
      • Guwahati, Índia, 781101
        • Recrutamento
        • All India Institute of Medical Science
        • Contato:
        • Investigador principal:
          • Masaraf Hussain, MD DM
      • Hyderabad, Índia, 500016
        • Recrutamento
        • KIMS-Sunshine Hospitals
        • Contato:
        • Investigador principal:
          • Shyam K Jaiswal, MD DNB
      • Hyderabad, Índia, 500034
        • Recrutamento
        • Renova Institute of Neurological Sciences (RINS); Renova Century Hospital
        • Contato:
        • Investigador principal:
          • Y Muralidhar Reddy, MD DM
      • Lucknow, Índia, 226014
        • Recrutamento
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
        • Contato:
        • Investigador principal:
          • Vinita E Mani, MD DM
      • New Delhi, Índia, 110029
        • Recrutamento
        • All India Institute of Medical Science
        • Contato:
        • Investigador principal:
          • Ayush Agarwal, MD DM
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, Índia, 522001
        • Recrutamento
        • Government General Hospital
        • Contato:
        • Investigador principal:
          • G Binod, MD DM
      • Guntur, Andhra Pradesh, Índia, 522001
        • Recrutamento
        • Lalitha Super Specialty Hospital
        • Contato:
        • Investigador principal:
          • Vijaya Pamidimukkala, MD DM
      • Guntur, Andhra Pradesh, Índia, 522004
        • Recrutamento
        • Dr Ramesh Cardiac and Multispecialty Hospital
        • Contato:
        • Investigador principal:
          • Somasundaram Kumaravelu, MD DM
      • Kākināda, Andhra Pradesh, Índia, 533003
        • Recrutamento
        • Government General Hospital
        • Contato:
        • Investigador principal:
          • Raviteja kakarla, MD DM
      • Nellore, Andhra Pradesh, Índia, 524003
        • Recrutamento
        • Narayana Medical College and Hospital
        • Contato:
        • Investigador principal:
          • N S Sampath, MBBS DNB MD
    • Assam
      • Guwahati, Assam, Índia, 781033
        • Recrutamento
        • Apollo Excelcare Hospitals
        • Contato:
        • Investigador principal:
          • Lakshya J Basumatary, MD DM
      • Tezpur, Assam, Índia, 784001
        • Recrutamento
        • Baptist Christian Hospital
        • Contato:
        • Investigador principal:
          • Jacob Johnson, MD
    • Bihar
      • Patna, Bihar, Índia, 801507
        • Recrutamento
        • All India Institute of Medical Science
        • Contato:
        • Investigador principal:
          • Pratibha Prasad, MD DM
    • Jharkhand
      • Ranchi, Jharkhand, Índia, 834009
        • Recrutamento
        • Rajendra Institute of Medical Sciences
        • Contato:
        • Investigador principal:
          • Surendra Kumar, MD DM
    • Karnataka
      • Belagavi, Karnataka, Índia, 590010
        • Recrutamento
        • KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
        • Contato:
        • Investigador principal:
          • Aralikatte O Saroja, MD DM
    • Kerala
      • Kochi, Kerala, Índia, 682041
        • Recrutamento
        • Amrita Institute for Medical Sciences and Research Center
        • Contato:
        • Investigador principal:
          • Vivek K Nambiar, MD DM
      • Thiruvananthapuram, Kerala, Índia, 695011
        • Recrutamento
        • Government Medical College Trivandrum
        • Contato:
        • Investigador principal:
          • Chithra P, MD DNB
      • Thiruvananthapuram, Kerala, Índia, 695011
        • Recrutamento
        • Sree Chitra Tirunal Institute for Medical Sciences and Technology
        • Contato:
        • Investigador principal:
          • Padmavathyamma N Sylaja, MD DM
    • Maharashtra
      • Mumbai, Maharashtra, Índia, 400016
        • Recrutamento
        • P. D. Hinduja Hospital and Medical Research Centre
        • Investigador principal:
          • Darshan Doshi, MD DM
        • Contato:
      • Pune, Maharashtra, Índia, 411043
        • Recrutamento
        • Bharati Vidyapeeth DTU Medical College
        • Contato:
        • Investigador principal:
          • Sankar P Gorthi, MD DM
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, Índia, 110095
        • Recrutamento
        • Institute of Human Behaviour and Allied Sciences
        • Contato:
        • Investigador principal:
          • Rajinder K Dhamija, MD DNB
    • Odisha
      • Bhubaneswar, Odisha, Índia, 751019
        • Recrutamento
        • All India Institute of Medical Sciences
        • Contato:
        • Investigador principal:
          • Sanjeev K Bhoi, MD DM
    • Punjab
      • Farīdkot, Punjab, Índia, 151203
        • Recrutamento
        • Guru Gobind Singh Medical College and Hospital
        • Contato:
        • Investigador principal:
          • Sulena Sulena, MD DM
    • Rajasthan
      • Bikaner, Rajasthan, Índia, 334001
        • Recrutamento
        • PBM Hospital
        • Contato:
        • Investigador principal:
          • Inder Puri, MD DM
      • Jaipur, Rajasthan, Índia, 302015
        • Recrutamento
        • Santokba Durlabhji Memorial Hospital
        • Contato:
        • Investigador principal:
          • Neeraj Bhutani, DM
      • Kota, Rajasthan, Índia, 324005
        • Recrutamento
        • Jaiswal Hospital and Neuro Institute
        • Contato:
        • Investigador principal:
          • Sanjay Jaiswal, MD DM
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, Índia, 641018
        • Recrutamento
        • KG Hospital and Post Graduate Medical Institute Coimbatore
        • Contato:
        • Investigador principal:
          • TCR Ramakrishnan, MD DM
      • Vellore, Tamil Nadu, Índia, 632517
        • Recrutamento
        • Christian Medical College Vellore
        • Contato:
        • Investigador principal:
          • Deepti Bal, DM
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Índia, 226003
        • Recrutamento
        • King George's Medical University
        • Contato:
        • Investigador principal:
          • Harish Nigam, MD DM
      • Raebareli, Uttar Pradesh, Índia, 229405
        • Recrutamento
        • All India Institute of Medical Sciences
        • Contato:
        • Investigador principal:
          • Archana Verma, MD DM
      • Varanasi, Uttar Pradesh, Índia, 221005
        • Recrutamento
        • Institute of Medical Sciences of the Banaras Hindu University (BHU)
        • Contato:
        • Investigador principal:
          • Abhishek Pathak, MD DM
    • West Bengal
      • Kolkata, West Bengal, Índia, 700020
        • Recrutamento
        • Bangur Institute of Neurosciences
        • Contato:
        • Investigador principal:
          • Biman K Ray, MD DM

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 99 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Aspirin 75 mg OD

The intervention is oral daily Aspirin 75 mg OD (antiplatelet drug monotherapy) in addition to standard care for secondary prevention after ICH based on the universal guidelines.
Medicamento: 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.

Outros nomes:
  • Aspirina
Comparador de Placebo: Placebo

The control arm is placebo, which will be look-alike both as kits and tablets and will be prescribed in the same way as Aspirin: OD along with the standard secondary prevention after ICH.
Medicamento: 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.

Outros nomes:
  • Placebo OD

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Major Adverse Cardiovascular Events (MACE)
Prazo: 3 years

To reduce the risk of first MACE (stroke, myocardial infarction, hospitalisation, or death) with antiplatelet monotherapy in ICH patients. The components of the MACE include ischemic stroke, haemorrhagic stroke, hospitalisation due to stroke (ischemic, haemorrhagic, subarachnoid haemorrhage), myocardial infarction, coronary artery disease, cerebral and cardiovascular death due to any vascular causes (including pulmonary embolism, gastrointestinal haemorrhage) or death due to non-Cerebrovascular and cardiovascular causes.
3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Major bleeding
Prazo: 3 years

To study the safety composite outcome of major bleeding (all major haemorrhagic events that are fatal or result in hospitalisation)
3 years
Medication adherence
Prazo: 3 years (every 3 months) till study end

To check the adherence of aspirin vs placebo.
3 years (every 3 months) till study end
modified Rankin Scale
Prazo: 3 years (every 3 months) till study end

To check the modified Rankin Scale (mRS), a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a ICH stroke.
3 years (every 3 months) till study end

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Christian Medical College and Hospital, Ludhiana, India

Colaboradores

Indian Council of Medical Research
King George's Medical University
All India Institute of Medical Sciences, Bhubaneswar
Christian Medical College, Vellore, India
Amrita Institute of Medical Sciences & Research Center
Rangaraya Medical College
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Narayana Medical College & Hospital
St. Stephen's Hospital, Delhi
Baptist Christian Hospital, Tezpur, India
Government General Hospital Guntur, India
Guru Gobind Singh Medical College & Hospital
PBM Hospital Bikaner, India
Bharati Vidyapeeth DTU Medical College Pune, India
KG Hospital and Post Graduate Medical Institute Coimbatore, India
Santokba Durlabhji Memorial Hospital
Government Medical College Trivandrum, India
Institute of Medical Sciences of the Banaras Hindu University, India
Bangur Institute of Neurosciences Kolkata
Lalitha Super Specialities Hospital
Dr. Ramesh Cardiac and Multispecialty Hospital Guntur, India
KLE'S Dr Prabhakar Kore Hospital & MRC Balgaum
Excelcare Hospitals Guwahati
Institute of Human Behaviour and Allied Sciences Delhi
Jaiswal Multispeciality Hospital And Neuro Institute, Kota
Renova Institute of Neurological Sciences (RINS); Renova Century Hospital Hyderabad
All India Institute of Medical Science, Patna, Bihar, India
Sri Balaji Institute of Medical Sciences, Raipur, Chhattisgarh, India
All India Institute of Medical Science, Guwahati
All India Institute of Medical Science, New Delhi
P. D. Hinduja Hospital and Medical Research Centre
KIMS-SUNSHINE Hospital, Hyderabad, India
Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India
All India Institute of Medical Science, Raebareli

Investigadores

  • Investigador principal: Jeyaraj D Pandian, MD, DM, Christian Medical College and Hospital, Ludhiana, Punjab, India

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de fevereiro de 2026

Conclusão Primária (Estimado)

15 de fevereiro de 2029

Conclusão do estudo (Estimado)

15 de fevereiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

17 de novembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de novembro de 2025

Primeira postagem (Real)

24 de novembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BEAT ICH

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

All information collected from medical records for the study will be stored electronically in a specifically designed database at the Christian Medical College and Hospital, Ludhiana, Punjab, India. Participants information will be identified only by their initials and a study registration number. Any information transferred electronically will be coded to protect confidentiality. All computer records will be password-protected. The study results may be presented at conferences or in scientific publications, but individual participants will not be identifiable. If needed, data will be available in future for other researchers outside the primary research group for secondary purposes, such as metaanalyses, reanalysis, or replication of results.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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