CTRI/2026/02/103841 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On:
10/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
Hypertension control in Stroke Patients after the clot removal surgery
Scientific Title of Study
Third Enhanced Control of Hypertension and Thrombectomy Stroke Study
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NCT06352619
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr P N Sylaja
Designation
Professor of Neurology
Affiliation
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Address
Comprehensive Stroke Care Program, Room No:3109, Stroke Office, Department of Neurology, Medical College P.O
Thiruvananthapuram KERALA 695011 India
Phone
04712524482
Fax
Email
sylajapn@hotmail.com
Details of Contact Person Scientific Query
Name
Dr Jeyaraj Durai Pandian
Designation
Principal and Professor
Affiliation
Christian Medical College and Hospital, Ludhiana
Address
Department of Neurology, Christian Medical College and Hospital, Brown Road, Ludhiana
Ludhiana PUNJAB 141008 India
Phone
9915784750
Fax
Email
jeyarajpandian@hotmail.com
Details of Contact Person Public Query
Name
Dr P N Sylaja
Designation
Professor of Neurology
Affiliation
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Address
Comprehensive Stroke Care Program, Room No:3109, Stroke Office, Department of Neurology, Medical College P.O
Thiruvananthapuram KERALA 695011 India
Phone
04712524482
Fax
Email
sylajapn@hotmail.com
Source of Monetary or Material Support
National Health and Medical Research Council (NHMRC) of Australia
The Canadian Institutes of Health Research (CIHR)
The George Institute for Global Health
University of Calgary, Calgary, Canada
Primary Sponsor
Name
Dr Craig Anderson
Address
The George Institute for Global Health,
Level 18, International Towers 3,
300 Barangaroo Ave,
Barangaroo NSW 2000 Australia
Email: canderson@georgeinstitue.org.au
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Australia Canada China India
Sites of Study
No of Sites = 25
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Sanjeev Kumar Bhoi
All India Institute of Medical Sciences, Bhubaneswar
Department of neurology, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar - 751019 Khordha ORISSA
9919787978
neuro_sanjeev@aiimsbhubaneswar.edu.in
Dr Ashish Sharma
All India Institute of Medical Sciences, Bilaspur
Department of Neurology, All India Institute of Medical Sciences, Bilaspur -174037 Bilaspur HIMACHAL PRADESH
9816397700
ashishsharmamd@yahoo.co.in
Dr Mritunjai Singh
All India Institute of Medical Sciences, Rishikesh
Department of Neurology, All India Institute of Medical Sciences, Shivaji Nagar, Rishikesh - 249203 Dehradun UTTARANCHAL
9997010096
mritunjasingh@gmail.com
Dr Vivek K Nambiar
Amrita Institute of Medical Sciences and Research Centre, Kochi
Department of Stroke Medicine, G block , Ground floor, Amrita Institute of Medical Sciences and Research Centre, Ponekkara, Edapally, Kochi, 682041
Ernakulam KERALA
Department of Neurosciences, Bangur Institute of Neurosciences, IPGME and R, Kolkata - 700020 Kolkata WEST BENGAL
9433185327
biman.kanti@rediffmail.com
Dr S P Gorthi
Bharati Vidyapeeth DTU Medical College, Pune
Department of Neurology, Bharati Vidyapeeth (DTU) Medical College and Hospital, Pune - 411043 Pune MAHARASHTRA
8800233991
spgorthi@gmail.com
Dr Ritwiz Bihari
Chandan Hospital, Lucknow
Department of Neurology, Chandan Hospital, Faizabad Road, Vijayant Khand, Gomti Nagar, Lucknow - 226010 Lucknow UTTAR PRADESH
7523835781
drritwizbihari@gmail.com
Dr Jeyaraj Durai Pandian
Christian Medical College and Hospital, Ludhiana
Department of Neurology, Christian Medical College and Hospital, Ludhiana, Brown Road, Ludhiana - 141008 Ludhiana PUNJAB
9915784750
jeyarajpandian@hotmail.com
Dr Sanjith Aaron
Christian Medical College, Vellore
Department of Neurological Sciences, Christian Medical College Vellore (Ranipet Campus), Kilminnal Village, Ranipet - 632 517 Vellore TAMIL NADU
9894022395
sanjith@cmcvellore.ac.in
Dr Sulena
Guru Gobind Singh Medical College and Hospital, Faridkot
Department of Neurology, Guru Gobind Singh Medical College and Hospital, Faridkot - 151203 Faridkot PUNJAB
7087907025
sulenasingh@yahoo.co.in
Dr Sunil K Narayan
Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry
Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthri Nagar, Pondicherry - 605006 Pondicherry PONDICHERRY
9443617120
sknarayan@gmail.com
Dr Aparna R Pai
Kasturba Hospital, Manipal
Department of Neurology, Kasturba Hospital, Manipal - 576104 Udupi KARNATAKA
9880182224
aparna.pai@manipal.edu
Dr TCR Ramakrishnan
KG Hospital and Post Graduate Medical Institute & Research Centre, Coimbatore
First floor, B Block, Department of Neurology, No. 5, Government Arts College Road, Coimbatore - 641018 Coimbatore TAMIL NADU
9443365792
priyarams01@gmail.com
Dr A O Saroja
KLEs Dr. Prabhakar Kore Hospital & Medical Resaerch Centre, Belagavi
Department of Neurology, KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre, J.N.Medical College Campus, Nehru Nagar, Belagavi-590010 Belgaum KARNATAKA
9448468474
sarojaao2002@yahoo.com
Dr P Vijaya
Lalitha Super Specialities Hospital Pvt Ltd, Guntur
Department of Neurosciences, Lalitha Super Specialities Hospital Pvt Ltd, Kothapet, Guntur - 522 001 Guntur ANDHRA PRADESH
9440808621
drvijayapvr@gmail.com
Dr Radhika Lotlikar
LMFF s Deenanath Mangeshkar Hospital & Research Center
Department of Neurology, LMFF s Deenanath Mangeshkar Hospital and Research Center, Erandawane, Pune 411004 Pune MAHARASHTRA
9967104512
radhika.lotlikar58@gmail.com
Dr Veena Vedartham
Manipal Hospital Bangalore
Department of Neurology, Manipal Hospital, #98 Old Airport road, Benagluru-560017 Bangalore KARNATAKA
9645422534
veenavedu@gmail.com
Dr Jayanta Roy
Manipal Hospitals, Mukundapur Cluster, Kolkata
Department of Neurology, Manipal Hospitals, Mukundapur Cluster, 223 & 230, Barakhola Lane, Purba Jadavpur, Mukundapur, Kolkata -700099 Kolkata WEST BENGAL
9836210993
jroyneuro01@gmail.com
Dr Girish Baburao Kulkarni
National Institute of Mental Health and Neurosciences (NIMHANS) Bangalore
Department of Neurology, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur road Bangalore-560029 Bangalore KARNATAKA
9035160614
gbk5000@rediffmail.com
Dr Darshan Doshi
PD Hinduja Hospital & MRC, Mumbai
Department of Neurology, PD Hinduja Hospital & MRC, Veer Savarkar Road, Mahim, Mumbai - 400016. Mumbai MAHARASHTRA
9845633469
darshankdoshi@gmail.com
Dr Neeraj Bhutani
Santokba Durlabhji Memorial Hospital, Jaipur
Department of Neurology, Santokba Durlabhji Memorial Hospital, Bhawani Singh Rd, Rambagh, Jaipur -302015 Jaipur RAJASTHAN
9828711808
drneerajbhutani@rediffmail.com
Dr Soaham Desai
Shree Krishna Hospital, Anand
Department of Neurology, Bhaikaka University, Shree Krishna Hospital and Medical Research Centre, Gokal Nagar, Karamsad-388 325, Anand Anand GUJARAT
9979937885
drsoahamdesai@yahoo.com
Dr P N Sylaja
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Room No. 3109, Stroke Office, Comprehensive Stroke Care Program, Department of Neurology, Medical College P.O. - 695011 Thiruvananthapuram KERALA
9446566287
sylajapn@hotmail.com
Dr Arvind Sharma
Zydus Hospital, Ahmedabad
Department of Neurology, Zydus Hospitals & Healthcare Research Pvt. Ltd., Zydus Hospitals Road, S.G.Highway, Thaltej, Ahmedabad - 380054 Ahmadabad GUJARAT
9409210486
dr_arvind10@yahoo.co.in
Details of Ethics Committee
No of Ethics Committees= 25
Name of Committee
Approval Status
Bharati Vidyapeeth Deemed University IEC
Submittted/Under Review
Ethics committee of Manipal Hospitals
Submittted/Under Review
IEC (BHR) AIIMS Bilaspur
Submittted/Under Review
IEC AIIMS Rishikesh
Submittted/Under Review
Institute Ethics Committee (Basic and Neurosciences Division), NIMHANS, Bangalore
The blood pressure will be controlled with the target of 175-180 mmHg
Intervention
Intensive SBP Control
The blood pressure will be controlled with the target of 140±5 mmHg
Intervention
Moderate SBP Control
The blood pressure will be controlled with the target of 160±5 mmHg
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Age greater than or equal to 18 years
2. Use of endovascular therapy (EVT) within 24 hours of symptom onset or last known well according to local guidelines;
3. Sustained high systolic blood pressure greater than or equal to 150 mmHg (2 readings less than 10 mins apart) within 3 hours after completion of EVT.
ExclusionCriteria
Details
1. Any definite contraindications to BP lowering treatment
Total length of hospital stay in the first 90-days after stroke onset
Day 90
Ambulatory status at discharge
NIL
Place of residence
Day 90
Mortality
Day 90
Any intracranial haemorrhage (ICH) and Symptomatic intracerebral haemorrhage (sICH)
NIL
SAEs
within 4 days
Target Sample Size
Total Sample Size="1900" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/03/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
11/10/2024
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - All of the individual participant data collected during the trial, after de-identification.
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response - Proposals should be directed to [canderson@georgeinstitue.org.au].
For how long will this data be available start date provided 01-11-2025 and end date provided 31-10-2033? Response - Beginning 3 months and ending 5 years following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP less than 130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 1,900 patients with SBP greater than equal to 150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP [greater than equal to 180mmHg]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP [150-160mmHg]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management.
As usual, hospital care during the study period, BP will be closely assessed up to day 4 to check adherence to the BP management protocol. The BP assessment frequency will be every 15 minutes for the first hour from domain randomisation, hourly from 1 hour to 8 hours, 4 hourly from 8 hours to 24 hours, and daily from Day 2 to Day 4. NIHSS will be conducted at baseline before randomisation into this domain. Randomisation will be stratified by country/region, and eTICI scores after EVT (less than or equal to 2b vs greater than or equal to 2c), using permuted blocks of varying sizes. Response Adaptive Randomisation (RAR) is not applicable in this domain. Randomisation will be centralized, secure, and concealed, using a web-based server, thus eliminating the possibility of imbalance in baseline prognostic variables and confounding by allocation bias. Investigators will rapidly access the randomiser using a web browser/application accessible using a username and password secured via multi-factor authentication. Primary outcome is modified Rankin scale (mRS) at 90 days analysed with utility-weighted mRS using a Bayesian hierarchical linear model. Adaptive analyses will be conducted 3-monthly with prespecified statistical triggers for superiority, inferiority and equivalence.