CTRI/2026/02/103867 [Registered on: 13/02/2026] Trial Registered Prospectively
Last Modified On:
07/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
Use of Intravenous Tenecteplase in Participants with Acute Ischemic Stroke
Scientific Title of Study
A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize the Use of Intravenous Tenecteplase in Participants with Acute Ischemic Stroke (ACT-WHEN)
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NCT06320431
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
University of Calgary,
Foothills Medical Centre
1403 29th Street NW
Calgary, Alberta, Canada T2N 2T9
Primary Sponsor
Name
University of Calgary
Address
Foothills Medical Centre
1403 29th Street NW
Calgary, Alberta, Canada T2N 2T9
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Australia Canada China India
Sites of Study
No of Sites = 28
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, Ponekkara, Edapally , Kochi Ernakulam KERALA
8921485541
dr.vivek.in@gmail.com
Dr Paul J Alapatt
Aster MIMS Hospital, Calicut
Department of Neurology, Mini- Bypass Road, Govindapuram P.O, Calicut Kozhikode KERALA
9447342034
pauljalapatt@gmail.com
Dr Biman Kanti Ray
Bangur Institute of Neurosciences, Kolkata
Department of Neurosciences, Bangur Institute of Neurosciences, IPGME&R, Kolkata - 700020 Kolkata WEST BENGAL
9433185327
biman.kanti@rediffmail.com
Dr Jacob Johnson
Baptist Christian Hospital, Tezpur
Baptist Christian Hospital, Mission Chariali, Tezpur-78400 Sonitpur ASSAM
7598626847
cooljacky44@gmail.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 Chitra P
Government Medical College, Thiruvananthapuram
Department of Neurology, Government Medical College, Medical College P.O - 695011 Thiruvananthapuram Thiruvananthapuram KERALA
9495202065
drchithrap5@gmail.com
Dr Shaji CV
Government T D Medical College, Alappuzha
Department of Neurology, Government T.D. Medical College, Vandanam Alappuzha KERALA
9947487778
drshajicv@gmail.com
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 & 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= 28
Name of Committee
Approval Status
Bharati Vidyapeeth Deemed University IEC
Submittted/Under Review
EHA Institutional Ethics committee
Submittted/Under Review
Ethics committee of Manipal Hospitals
Submittted/Under Review
Human Ethics Committee, GMC, Thiruvananthapuram
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
Low-dose intravenous tenecteplase (0.18 mg/kg body weight)
Intervention
Intravenous tenecteplase
Standard-dose intravenous tenecteplase (0.25 mg/kg body weight)
Comparator Agent
No intravenous tenecteplase
Only participants on Direct Oral Anticoagulants (DOACs) or those scheduled for emergency endovascular thrombectomy (EVT) are eligible for no intravenous tenecteplase. Participants who are on DOACs within the last 48 hours or those planned for emergency EVT will be randomized to receive either
Standard-dose intravenous tenecteplase (0.25 mg/kg body weight)
(OR)
Low-dose intravenous tenecteplase (0.18 mg/kg body weight)
(OR)
No intravenous tenecteplase
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. Clinical diagnosis of stroke
3. All patients with disabling AIS presenting within 4.5 hours of symptom onset or last known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase. Patients potentially eligible for IVT with conditions described as relative contraindications in national guidelines where physician discretion is recommended are eligible. Patients who received a DOAC, and those planned for EVT are eligible.
4. Consent process completed as per national laws and regulations and the applicable ethics committee requirements.
ExclusionCriteria
Details
1. Any absolute contraindication for IV thrombolysis per current national guidelines. Examples include those who have active bleeding, recent (less than 7 days) intracranial surgery, head trauma, intracranial or subarachnoid hemorrhage, or have a bleeding diathesis.
2. Minor stroke patients with non-disabling symptoms.
Method of Generating Random Sequence
Permuted block randomization, variable
Method of Concealment
Centralized
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
modified Rankin scale (mRS) scores
Day 90
Secondary Outcome
Outcome
TimePoints
Proportion of participants with mRS score of 0-1
Day 90
Proportion of participants with mRS score of 0-2
Day 90
Health-related quality of life, as measured by the EQ-5D-5L
Day 90
Ordinal shift of 7 levels of mRS at 90 days
Day 90
Ambulatory status at discharge
NIL
Place of residence
Day 90
Imaging assessments (e.g., infarct and edema volumes)
NIL
Proportion of participant achieving revised arterial occlusive lesion [rAOL] score of 2b-3 at first angiographic images (when treated with EVT)
NIL
Proportion of participants achieving first pass reperfusion expanded treatment in cerebral ischemia (eTICI) 2c or higher (when treated with EVT)
NIL
Summative total length of hospital stay in the first 90-days after stroke onset
Day 90
Mortality
Day 90
Symptomatic intracranial hemorrhage, Large parenchymal hemorrhage (PH-2)
NIL
SAEs
Within 4 days
Target Sample Size
Total Sample Size="4000" Sample Size from India="500" 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)
26/09/2024
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="5" 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 [bkmmenon@ucalgary.ca].
For how long will this data be available start date provided 01-11-2025 and end date provided 31-10-2035? 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
This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment.
This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient.
This domain will currently evaluate four research questions about the use of IVT with tenecteplase:
1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all.
2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all.
3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg).
4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age, or having a heavy burden of cerebral small vessel disease on brain imaging?