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CTRI Number  CTRI/2024/10/074833 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A study on factors influencing anticoagulant prescriptions and patient outcomes  
Scientific Title of Study   A single-center, prospective, observational study to evaluate the factors influencing the prescription choices of anticoagulants and to assess the outcomes in patients prescribed these specific anticoagulants.  
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 Shilpa Gupta 
Designation  Consultant Haemato-oncology  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPd No. 03, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra,India,401107

Thane
MAHARASHTRA
401107
India 
Phone  9820803843  
Fax    
Email  shilpagupta0707@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpa Gupta 
Designation  Consultant Haemato-oncology  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPd No. 03, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra,India,401107

Thane
MAHARASHTRA
401107
India 
Phone  9820803843  
Fax    
Email  shilpagupta0707@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpa Gupta 
Designation  Consultant Haemato-oncology  
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPd No. 03, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra,India,401107

Thane
MAHARASHTRA
401107
India 
Phone  9820803843  
Fax    
Email  shilpagupta0707@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Mira Bhayandar, Maharashtra 401107 
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 
Dr Shilpa Gupta   Bhaktivedanta Hospital and Research Institute  Room No. 3, Oncology Department, B wing, 1st Floor, Bhaktivedanta Swami Marg, Sector 6, Sector 1, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA 
9820803843

shilpagupta0707@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committe For Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D65-D69||Coagulation defects, purpura and other hemorrhagic conditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All IPD and OPD patients who require VKAs or NOACs 
 
ExclusionCriteria 
Details  Patients who are not willing to participate in the study.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify the key factors that influence the prescription of anticoagulants in patients
• Evaluate the distribution of different types of anticoagulants prescribed
• Assess the adherence rates to prescribed anticoagulant therapy
• Identify factors contributing to non-adherence, including patient follow-up, and side effects
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   18/10/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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  

Anticoagulants are vital for managing thromboembolic diseases, with the choice of therapy influenced by patient-specific factors like age, body weight, renal function, and comorbidities. Direct oral anticoagulants (DOACs) are favored for their predictable effects and ease of use, though traditional vitamin K antagonists (VKAs) remain important in certain cases. Clinicians must carefully consider drug interactions, patient preferences, and clinical guidelines to optimize therapy and minimize risks. This study aims to analyze the impact of these variables on anticoagulant prescribing practices and associated outcomes. Primary Objective of study is to evaluate the factors influencing anticoagulant prescription in patients. Secondary Objective of the study is assessing the outcomes in patients who are prescribed anticoagulants. The study is designed as single-center, prospective, observational study. The Inclusion criteria for study is for All IPD and OPD patients who require VKAs or NOACs and Patients who are not willing to participate in the study are excluded. At visit 1, data parameters like patient demography and Clinical Details will be recorded such as Indication, Anticoagulant dose/frequency, expected duration, Reason for choice, Thrombosis etiology/site. On Telephonic Follow-Up,  visit 2 (3rd month) and visit 3 (6th month) certain data will be recorded such as Adverse Events and if yes, its Occurrence information. and Symptomatic Relief. Total sample size of study is 86 cases and study duration is 1 year. The Endpoints of study is To identify the key factors that influence the prescription of anticoagulants in patients, Evaluate the distribution of different types of anticoagulants prescribed, Assess the adherence rates to prescribed anticoagulant therapy and Identify factors contributing to non-adherence, including patient follow-up, and monitor side effects

 
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