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CTRI Number  CTRI/2024/05/067056 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Impact of Influenza Vaccine in reducing adverse events in patients with recent heart attack 
Scientific Title of Study   Influenza Vaccine to reduce cardiovascular events in patients with recent myocardial infarction: a multicentric randomized, double-blind palcebo-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 Ambuj Roy 
Designation  Professor of Cardiology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 20, 7th floor, Department of Cardiology, C. N .Center, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9810992822  
Fax    
Email  drambujroy@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambuj Roy 
Designation  Professor of Cardiology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 20, 7th floor, Department of Cardiology, C. N .Center, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9810992822  
Fax    
Email  drambujroy@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Dr Ambuj Roy 
Designation  Professor of Cardiology 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 20, 7th floor, Department of Cardiology, C. N .Center, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9810992822  
Fax    
Email  drambujroy@aiims.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Indian Council of Medical Research, India 
Address  ICMR Office, Ansari Nagar, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surender Deora  All India Institute of Medical Sciences , Jodhpur  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 8003996715

drsdeora@gmail.com 
Dr Ambuj Roy  All India Institute of Medical Sciences, New Delhi  Room No 20, 7th floor, Department of Cardiology, C. N Center, AIIMS, Ansari Nagar, New Delhi
South
DELHI 		 9810992822

drambujroy@aiims.edu 
Dr Barun Kumar  All India Institute of Medical Sciences, Rishikesh  Shivaji Nagar, Rishikesh, Veerbhadra, Uttarakhand 249203
Hardwar
UTTARANCHAL 		 8475000331

drbarun79@gmail.com 
Dr Sanjeev Asotra  Atal Institute of Medical Super Specialties  Room no 308, B block, 3rd floor, Department of Cardiology, Ridge Sanjauli Rd, Lakkar Bazar, Shimla, Himachal Pradesh 171001
Shimla
HIMACHAL PRADESH 		 9418080804

dr.sanjeev00@gmail.com 
Dr Bishav Mohan  DMC Ludhiana  Department of Cardiology, Civil Lines, Tagore Nagar, Ludhiana, Punjab 141001
Ludhiana
PUNJAB 		 9876741158

bishav_68@yahoo.co.in 
Dr Girish MP  G.B Pant, New Delhi  Room no 125, 1st Floor, Academic Block, Number-1, Near Delhi Gate, Jawahar Lal Nehru Marg, Asaf Ali Road-110002 near Delhi Gat
New Delhi
DELHI 		 9891117573

mpgirish_1999@yahoo.com 
Dr Sharad Chandra  King George Medical University  Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 		 9616279212

sharadaiims@gmail.com 
Prof Justin Paul Gnanaraj  Madras Medical College  Poonamallee High Rd, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU 		 9840071558

drjpheart@gmail.com 
Dr Amit Malviya  North Eastern Indira Gandhi Regional Instt. of Health and Medical Sciences  HWRR+C67, Mawdiangdiang, Shillong, Meghalaya 793018
East Khasi Hills
MEGHALAYA 		 8794705698

dramit_malviya@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Drug Trial Ethics Committee, DMC Ludhiana  Approved 
Ethics Committee, IGMC Shimla  Submittted/Under Review 
Institute Ethics Committee, AIIMS, Delhi  Approved 
Institution Ethics Committee, NEIGRIHMS  Approved 
Institutional Ethics Committee (Clinical Trials, AIIMS Jodhpur)  Approved 
Institutional Ethics Committee, AIIMS Rishikesh  Approved 
Institutional Ethics Committee, KGMU  Approved 
Institutional Ethics Committee, Madras Medical College, Chennai  Approved 
Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Influenza vaccine  Seasonal inactivated quadrivalent Influnenza Vaccine 0.5 ml annually minimum for one year and maximum for three years 
Comparator Agent  Placebo  Sterile saline 0.5 ml annually minimum for one year and maximum for three years 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  - Patients > 45 year old with physician diagnosed MI (ST elevation and non ST elevation) in the previous 12 weeks consenting to participate will be randomized to intervention or control arm  
 
ExclusionCriteria 
Details  1) Anaphylactic reaction to a previous dose of influenza vaccine,
2) IgE-mediated hypersensitivity to egg protein manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock;
3) Guillain-Barré syndrome within eight weeks of a previous influenza vaccine;
4) Anaphylactic reaction to neomycin
5) Influenza vaccine in the previous one year;
6) Plan to be vaccinated with flu vaccine in coming year  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be a composite of all cause death, non-fatal myocardial infarction, non-fatal stroke and all-cause hospitalizations using standardized criteria from time of randomization during the peak influenza season.   Study Duration will be of four year which include

6 months for ethical approvals, sites initiation, training.

6 months of sites close out and data analysis.

Patient will be administered study vaccine or placebo annually with minimum follow up of one year and maximum follow up of 2.5 years.  
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome will be the composite outcome of all cause death, non-fatal myocardial infarction, non-fatal stroke and all cause hospitalizations during the entire period of the study; Individual components of the composite outcome- all-cause death; cardiovascular death; non-fatal myocardial infarction; non-fatal stroke; all-cause hospitalisation; hospitalisation for heart failure; and pneumonia will be the other secondary outcomes  Study Duration will be of four year which include

6 months for ethical approvals, sites initiation, training.

6 months of sites close out and data analysis.

Patient will be administered study vaccine or placebo annually with minimum follow up of one year and maximum follow up of 2.5 years. 
 
Target Sample Size   Total Sample Size="3600"
Sample Size from India="3600" 
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 4 
Date of First Enrollment (India)   01/10/2024 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Rationale: Influenza is known to trigger acute myocardial infarction and recent trials in patients with myocardial infarction (MI) have revealed reduction in deaths in those receiving influenza vaccine. However, all these trials are from temperate countries with definite seasonality of influenza vaccine. The only trial of influenza vaccine outside of temperate regions in heart failure patients was negative. Thus, a trial of influenza vaccine in India, with large number of coronary artery disease patients, is needed to make an informed decision on whether similar benefit would accrue in our patients.

Novelty: No randomised trial on benefits of influenza vaccine in patients of MI available from tropical and developing countries.

Objectives: To assess the impact of influenza vaccine in reducing major adverse cardiovascular events (MACE) in patients with recent MI.

Methods: A total of 3600 patients with recent acute MI (ST elevation and Non-ST elevation MI in previous 12 weeks) will be randomised to receive seasonal inactivated quadrivalent influenza vaccine or placebo saline injection. The primary end point will be reduction in major adverse cardiovascular events (MACE) of all-cause death, non-fatal MI, non-fatal stroke and all-cause hospitalization. The patients will be followed up for a minimum of 12 months.

Expected outcomes: The primary outcome will be a composite of all cause death, non-fatal myocardial infarction, non-fatal stroke and all-cause hospitalizations using standardized criteria from time of randomization during the peak influenza season. Secondary outcome will be the composite outcome of all cause death, non-fatal myocardial infarction, non-fatal stroke and all cause hospitalizations during the entire period of the study; Individual components of the composite outcome- all-cause death; cardiovascular death; non-fatal myocardial infarction; non-fatal stroke; all-cause hospitalisation; hospitalisation for heart failure; and pneumonia will be the other secondary outcomes             

                                                                                                                                                                                                                               

 
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