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CTRI Number  CTRI/2025/11/098037 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study on the Role of Anti-Inflammatory Therapy in reducing the risk of further cardiac events in patients with Stable Heart Disease 
Scientific Title of Study   Efficaacy assessment of low dose colchicine for secondary risk reduction in patients with stable coronary artery disease - A 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 Akshaya Kamalashree 
Designation  MD Post Graduate 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of General Medicine SRM Medical College Hospital and Research Centre, Potheri Kattankulathur Tamil Nadu 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  8637665894  
Fax    
Email  kamalashreeg@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jennie Suresh 
Designation  Professor 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of General Medicine SRM Medical College Hospital and Research Centre, Potheri Kattankulathur Tamil Nadu 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9445686996  
Fax    
Email  jenniesureshkumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akshaya Kamalashree 
Designation  MD Post Graduate 
Affiliation  SRM Medical College Hospital and Research Centre 
Address  Department of General Medicine SRM Medical College Hospital and Research Centre, Potheri Kattankulathur Tamil Nadu 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  8637665894  
Fax    
Email  kamalashreeg@gmail.com  
 
Source of Monetary or Material Support  
department of general medicine, srm medical college hosptial and research centre,potheri,kattankulathur,603203 
 
Primary Sponsor  
Name  Dr Akshaya Kamalashree 
Address  Department of General Medicine SRM Medical College Hospital and Research Centre, Potheri Kattankulathur, Tamil Nadu 603203  
Type of Sponsor  Other [SELF] 
 
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 
Dr Akshaya kamalashree  SRM Medical College Hospital and Research Centre  Department of General Medicine, H Block, Mahatma Gandhi Rd, Potheri, SRM Nagar, Kattankulathur, Tamil Nadu 603203
Kancheepuram
TAMIL NADU 		 08637665894

kamalashreeg@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL STUDENTS INSITITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Colchicine Group  Based on Inclusion and Exclusion criteria patient will be started on Tab Colchicine 0.5mg once a day along with his/her usual drugs for secondary Coronary Artery Disease prevention.Hscrp levels are checked before initiation of Tab Colchicine and 90 days after initiation of the drug. 
Comparator Agent  Regular Coronary Artery Diseas prevention drugs   Based on Inclusion and Exclusion criteria patient will be continued on his/her usual Coronary Artery disease prevention drugs for 90 days, following which hs-CRP value is checked. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) angiographically proven coronary disease
2) clinically stable greater than 6 months Post CAD diagnosis on regular secondary CAD prevention medications
3) hsCRP greater than 2 mg/L
4) considered compliant with therapy and follow-up at 1 & 3 months
5) willing to provide consent to participate in the study  
 
ExclusionCriteria 
Details  1 ) Renal failure eGFR less than 50 ml per min per 1.73 m2
2 ) Liver failure
3 ) active infection
4 ) Blood dyscrasias
5 ) Auto immune disorders
6 ) on Glucocorticoid therapy
7 ) on Colchicine for gout
8 ) Heart failure LVEF lesser than 40 percent
9 ) Pregnant or breast feeding
10) on strong CYP3A4 ; p- glycoprotein inhibitors – Azole antifungals , clarithromycin , Lopinavir
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure the effect of Colchicine in reducing hs-CRP levels and preventing major adverse cardiovascular events in patients with stable Coronary Artery Disease  hsCRP value at baseline, and 90 days after initiation of drug therapy. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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   N/A 
Date of First Enrollment (India)   06/12/2025 
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="0"
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 - NO
Brief Summary  

Consent will be obtained from eligible participants of the study basing on the above mentioned

inclusion and exclusion criteria. Demographic information, lifestyle data, and medical history data

will be collected from all participants.. Each participant will be asked to visit the hospital for review after 30 days and after 90 days of starting the drug. Adverse effects in the study population noted.Any primary end point such as cardiovascular death , spontaneous myocardial infarction , ischemic stroke, or ischemia-driven coronary revascularization will be documented during study period  .hsCRP will be tested at 3 months if no MACE occurred.

 
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