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CTRI Number  CTRI/2015/12/006455 [Registered on: 22/12/2015] Trial Registered Retrospectively
Last Modified On: 11/07/2016
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A study to assess the effect of patient related factors on warfarin dosing. 
Scientific Title of Study   AN OBSERVATIONAL STUDY TO ASSESS THE EFFECT OF PATIENT SPECIFIC FACTORS ON MAINTAINANCE DOSE OF WARFARIN 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EC/NIMS/1546/2014  Protocol Number 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramakanth GSH 
Designation  Senior Resident 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Clinical Pharmacology and Therapeutics Nizams Institute of Medical Sciences Hyderabad
Nizams Institute of Medical Sciences Punjagutta Hyderabad 500082
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9703633788  
Fax  9703633788  
Email  grk234@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Ramakanth GSH 
Designation  Senior Resident 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Clinical Pharmacology and Therapeutics Nizams Institute of Medical Sciences Hyderabad
Nizams Institute of Medical Sciences Punjagutta Hyderabad 500082
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9703633788  
Fax  9703633788  
Email  grk234@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Ramakanth GSH 
Designation  Senior Resident 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept of Clinical Pharmacology and Therapeutics Nizams Institute of Medical Sciences Hyderabad
Nizams Institute of Medical Sciences Punjagutta Hyderabad 500082
Hyderabad
ANDHRA PRADESH
500082
India 
Phone  9703633788  
Fax  9703633788  
Email  grk234@yahoo.co.in  
 
Source of Monetary or Material Support  
Self, Dept of Clinical Pharmacology and therapeutics, Nizams Institute of Medical Sciences, Hyderabad. 
 
Primary Sponsor  
Name  Ramakanth GSH 
Address  Dept of Clinical Pharmacology and Therapeutics NIMS Hyderabad 
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 Ramakanth GSH  Nizams Institute of Medical Sciences  Division of Clinical Research Department of Clinical Pharmacology Nizams Institute of Medical Sciences Punjagutta Hyderabad 500082
Hyderabad
ANDHRA PRADESH 		 9703633788

grk234@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  cardiovascular disease patients recieving warfarin therapy ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of either sex in age group between 18 to 65 years on warfarin therapy with INR between 2 to 3.5 and with stable total warfarin maintenance dose for three consecutive months will be included for the study. 
 
ExclusionCriteria 
Details  Patients with INR outside the range of 2 to 3.5 and non-compliant to warfarin therapy and study procedure will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of one–week vitamin K intake on total weekly warfarin dose  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of data collected on age, gender and tobacco &/or alcohol consumption on total weekly warfarin dose  1 week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   This study is being conducted as a post graduate thesis and the results will be published after the thesis gets accepted and with the permission of the ethics committee 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Warfarin therapy is widely used for the prevention of thromboembolic events for a variety of medical conditions. The goal of anticoagulant therapy with warfarin is to administer the lowest effective dose of the drug to maintain the target international normalized ratio (INR). The dosing of warfarin is patient-specific. The initiation and maintenance of warfarin therapy is based on the international normalized ratio (INR) levels. Also, the safety and efficacy of warfarin therapy are dependent on maintaining the INR within the target range for the indication.  Warfarin dose may be variable which can be explained, to some extent, by concomitant medications, gender, nutritional status, liver disease, alcohol consumption, diarrhea, hyperthyroidism, fever, chronic heart failure (CHF), and, ethnicity. Warfarin has a narrow therapeutic window and has been associated with many drug-drug and drug-food interactions. However, little evidence is available concerning the impact of other factors, such as body mass index (BMI) and vitamin K intake. Clearly defined effects of patient factors on warfarin dose may better facilitate achievement of therapeutic INRs following initiation of warfarin therapy.

 
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