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抗血小板療法による脳内出血患者の心血管イベント負担の軽減 (BEAT-ICH)

2026年9月21日 更新者：Jeyaraj D Pandian、Christian Medical College and Hospital, Ludhiana, India

脳内出血患者における抗血小板療法による心血管イベント負担の軽減

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

5676

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
薬：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.

他の名前：
  • アスピリン
プラセボコンパレーター：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.
薬：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.

他の名前：
  • プラセボ OD

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Major Adverse Cardiovascular Events (MACE)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Major bleeding
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Christian Medical College and Hospital, Ludhiana, India

協力者

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

捜査官

  • 主任研究者：Jeyaraj D Pandian, MD, DM、Christian Medical College and Hospital, Ludhiana, Punjab, India

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年2月16日

一次修了 (推定)

2029年2月15日

研究の完了 (推定)

2029年2月15日

試験登録日

最初に提出

2025年11月17日

QC基準を満たした最初の提出物

2025年11月17日

最初の投稿 (実際)

2025年11月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BEAT ICH

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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