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CTRI Number  CTRI/2020/06/025932 [Registered on: 17/06/2020] Trial Registered Prospectively
Last Modified On: 15/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Diabetes Risk After Acute Coronary Syndrome on statins  
Scientific Title of Study   To evaluate the incidence of new onset diabetes in acute coronary syndrome patients on statins and evaluate the dose related risk.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Walia 
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103, Department of Cardiology , All India Institute of Medical Science , Rishikesh.

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Rohit Walia 
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103, Department of Cardiology , All India Institute of Medical Science , Rishikesh.

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Rohit Walia 
Designation  Assistant Professor Incharge Electrophysiology , Heart Failure Special Clinic  
Affiliation  All India Institute of Medical Science Rishikesh  
Address  Room number 25103, Department of Cardiology , All India Institute of Medical Science , Rishikesh.

Dehradun
UTTARANCHAL
249203
India 
Phone  8800492549  
Fax    
Email  rwalia7731@yahoo.in  
 
Source of Monetary or Material Support  
All India Institute of Medical science , Virbdahra Road , Pashulok , Rishikesh , Dehradun, Uttarakhand , India . Pin - 249203 
 
Primary Sponsor  
Name  Rohit Walia  
Address  Room 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh , Uttarakhand  
Type of Sponsor  Other [Principal investigator ] 
 
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 
Rohit Walia   All India Institute of Medical Science Rishikseh   Room number 25103, Department of Cardiology
Dehradun
UTTARANCHAL 		 8800492549

rwalia7731@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Science Rishikesh   Approved 
 
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  Atorvastatin 80 mg for 6 months followed by atorvastatin 10 mg for 6 months   Atorvastatin 80 mg for 6 months followed by atorvastatin 10 mg for 6 months orally once a day night  
Comparator Agent  Parvastatin   Parvastatin 80 mg for 6 months followed by 20 mg for 6 months , orally once a day night  
Comparator Agent  Pitavastatin   Pitavastatin 4 mg for 6 months and 1 mg for next 6 months , orally once a day at night .  
Comparator Agent  Rosuvastatin   Rosuvastatin 20 mg for 6 months followed by 5 mg for 6 months . orally once a day night  
Comparator Agent  Simvastatin   Simvastatin 40 mg for 6 months and 10 mg for next 6 months orally once a day night for 12 months  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 18 - 65 years
Acute Coronary Syndrome patients
Non diabetic 
 
ExclusionCriteria 
Details  Diabetes
Already taking lipid lowering drugs or hypoglycaemic drugs
Hypo or hyperthyroid disorders
Advanced Malignancy
Advanced Heart Failure
Taking steroids
Renal failure
Any chronic infection
Genetic Hypercholestrolemic disorders  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Incidence of new onset diabetes at 6 months with maximum dose of statin   1. Incidence of new onset diabetes at 6 months with maximum dose of statin  
 
Secondary Outcome  
Outcome  TimePoints 
Degree of change in FBG , PPBG , HbA1c from baseline to 6 months on maximum dose of statin
 		 6 months  
Degree of change in FBG , PPBG , HbA1c after 6 months from maximum to minimum dose.  at 1 year of study drug initiation  
Cardiovascular Events during follow up over 1 year and difference between intensive and low intensity phase.   1 year  
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   25/06/2020 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Statins have been linked to new onset diabetes. No randomised control trail is there to prove definite causation. We plan to study acute coronary syndrome patients who receive high dose statins and look at blood sugar and insulin resistance to determine their effect on inducing new onset diabetes. We study different statins : atorvastatin , simvastatin , rosuvastatin . pitavastatin , parvastatin to see which has highest effect on inducing new onset diabetes. The study participants are encouraged to maintain healthy diet and body weight over duration of study. After 6 months of intensive high dose statin the dose of statin will be reduced to minimal required and participants followed up over next 6 months. The change in blood sugar levels from baseline to highest dose of statin at 6 month and minimal dose of statin at 1 year of start of study will be assessed. Incidence of new onset diabetes and cardiovascular events will be recorded.  
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