FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077319 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 20/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A STUDY ON ISCHEMIC STROKE PATIENTS COMPARING THE EFFECTIVENESS OF TWO MEDICINES- TENECTEPLASE AND ALTEPLASE IN DISSOLVING BLOOD CLOTS 
Scientific Title of Study   TENECTEPLASE VERSUS ALTEPLASE FOR THROMBOLYSIS IN ACUTE ISCHEMIC STROKE- AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dolly Agrawal 
Designation  Academi senior resident Neurology 
Affiliation  AIIMS JODHPUR 
Address  Neurology department, AIIMS Jodhpur, Heavy industrial area phase 2, Basni , Jodhpur, Rajasthan, 342005, India

Jodhpur
RAJASTHAN
342005
India 
Phone  7648927909  
Fax    
Email  dollyagrawal3119@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samhita Panda 
Designation  Professor and HOD Department of neurology AIIMS Jodhpur 
Affiliation  AIIMS Jodhpur 
Address  Neurology department AIIMS jodhpur heavy industrial area phase 2 Basni Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9810838268  
Fax    
Email  samhitapanda@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Samhita Panda 
Designation  Professor and HOD Department of neurology AIIMS Jodhpur 
Affiliation  AIIMS Jodhpur 
Address  Neurology department AIIMS jodhpur heavy industrial area phase 2 Basni Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9810838268  
Fax    
Email  samhitapanda@yahoo.com  
 
Source of Monetary or Material Support  
AIIMS JODHPUR 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  Department of neurology AIIMS Jodhpur Heavy industrisl area phase 2 Basni Jodhpur PIN- 342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDolly Agrawal  AIIMS JODHPUR  Department of Neurology AIIMS Jodhpur heavy industrial area phase 2 Basni Jodhpur, Rajasthan PIN 342005
Jodhpur
RAJASTHAN 		 7648927909

dollyagrawal3119@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institue of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G46||Vascular syndromes of brain in cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ALTEPLASE INJECTION  Eligible patients shall be randomly assigned as per block randomization to intravenous thrombolytic agent. Eligible patients shall be given intravenous thrombolytic agent alteplase 0.9 mg/kg to a maximum of 90 mg with 10% as a bolus and rest as an infusion over 1 hour  
Intervention  TENECTEPLASE INJECTION  Eligible patients shall be randomly assigned as per block randomization to intravenous thrombolytic agent. Eligible patients shall be given intravenous thrombolytic agent Tenecteplase as bolus dose of 0.25 MG/KG (maximum of 25 mg) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  age more than or equal to 18 years,
patients with acute ischemic stroke,
onset of symptoms less than 4.5 hours, if exact time of stroke is unknown,it is defined as the last time the patient was known to be normal or at neurologic baseline.
Wake up stroke-patients with acute ischemic stroke who wake up with stroke symptoms or have unclear time of onset more than 4.5 hours from last known wellor at baseline state and who have a DW-MRI lesionsmaller than one third of the MCA territory and no visible signal change on FLAIR . Diffusion FLAIR mismatch.
Informed and signed consent.  
 
ExclusionCriteria 
Details  Ischemic stroke or severe head trauma in previous three months,
previous intracranial haemorrhage,
patient with intracerebral haemorrhage in NCCT head,
persistent blood pressure elevation( SBP more than or equal to 185 mm hg or DBP more than or equal to 110 mm hg),
intra-axial intracranial neoplasm,
Gastrointestinal malignancy,
Gastrointestinal haemorrhage in previous 21 days,
Infective endocarditis,
Aortic arch dissection,
Acute head trauma,
Subarachnoid haemorrhage,
Minor non disabiling stroke,
Intracranial or intraspinal surgery within prior 3 months,
major surgery in preceeding 14 days,
recent history of ICH, subarachnoid haemorrhage, AVM, aneurysm or cerebral neoplasm,
Arterial puncture at non compressible site in previous 7 days,
acute bleeding diasthesis,
platelet count less than 1 lakh/mm3,
pregnant female,
non availability of inr if patient is on vka,
current anticoagulant use with inr more than 1.7 or pt more than 15 seconds or aptt more than 40 seconds,
therapeutic doses of low molecular heparin received within 24 hours example to treat vte and acs, this exclusion doesnot apply to prophylactic dose,example to prevent VTE,
Use of glycoprotein IIbIIIa inhibitors within past 72 hours,
patient of acute ischemic stroke who are thrombolysed outside the study centre,
Current use (that is last dose within 48 hours in a patient with normal renal function) of a direct thrombin inhibitor or direct factor Xa inhibitor with evidence of anticoagulant effect by laboratory tests such as APTT,INR,ECT,TT or appropriate factor Xa activity assays,
patient who gave negative consent for intravenous thrombolysis

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in NIHSS at 24 hours and at 72 hours post thrombolysis  24 hours and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.mRS at 1 month and at 3 months
2.Radiological evolution on the basis of NCCT head and CTA
3.need for decompression surgery 		 mRS- 1 month and 3 months,
radiological evolution- baseline and at 24 hours after thrombolysis 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   05/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dollyagrawal3119@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This open label, randomized controlled trial of tenecteplase versus alteplase for thrombolysis in  acute ischemic stroke assesses the efficacy and safety of tenecteplase versus alteplase as thrombolytic agents in acute ischemic stroke patients within 4.5 hours of symptom onset. As soon as suspected stroke patient visit AIIMS Jodhpur, imaging is done. Eligible patients, who follows the inclusion criteria and after ruling out the exclusion criterias, undergo randomisation for either tenecteplase or alteplase administration by block randomisation method.  After taking Written informed consent  from the patient family members, patient will be thrombolysed with either tenecteplase (bolus 0.25 mg per kg ,maximum 25 mg ) or alteplase (0.9 mg/kg maximum 90 mg, with 10 percent of total dose as bolus and remaining dose as infusion over 1 hour )  as per randomisation group. This is followed by repeat imaging after 24 hours and neurological assessment will be done to compare outcomes including NIHSS, mRS and other safety outcomes. Adverse effects will be managed. patient will be assessed in follow up for NIHSS and mRS.  
Close