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CTRI Number  CTRI/2024/12/077975 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Personalized Blood Thinner Treatment Advancing Care for Patients with Blood Clotting Disorders through Genetic Testing 
Scientific Title of Study
Modification(s)  
Development and validation of a prediction model for personalized Newer Oral anticoagulant (NOAC) therapy in patients with thromboembolic events by integrating Pharmacogenomics and cost-effectiveness: A prospective Interventional study 
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 Vivek Nambiar 
Designation  Associate Professor 
Affiliation  Amrita Institute of Medical Sciences 
Address  Ground Floor, G Block, Department of Stroke Medicine, Amrita Institute of Medical Sciences and Research Centre, Ponekkara, Kochi, Kerala 682041, India

Ernakulam
KERALA
682041
India 
Phone  8921485541  
Fax    
Email  dr.vivek.in@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Nambiar 
Designation  Associate Professor 
Affiliation  Amrita Institute of Medical Sciences 
Address  Ground Floor, G Block, Department of Stroke Medicine, Amrita Institute of Medical Sciences and Research Centre, Ponekkara, Kochi, Kerala 682041, India

Ernakulam
KERALA
682041
India 
Phone  8921485541  
Fax    
Email  dr.vivek.in@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chameli Ratan 
Designation  PhD Scholar 
Affiliation  Amrita School of Pharmacy 
Address  Room Number 3,Department of Pharmacy Practice, Block A, Amrita Institute of Medical Sciences, Ponekkara, Kochi, Kerala 682041 Ernakulam KERALA India

Ernakulam
KERALA
682041
India 
Phone  9446338184  
Fax    
Email  chameliratan@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Amrita Institute of Medical Sciences 
Address  Amrita Institute of Medical Sciences, Ponekkara,Kochi,Kerala-682041 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vivek Nambiar  Amrita Institute of Medical Sciences   G block, Ground floor,Amrita Institute of Medical and Research,Amrita Vishwa Vidyapeetham, Edappally, Kochi-682041
Ernakulam
KERALA 
8921485541

dr.vivek.in@gmail.com 
Dr Sanjith Aaron  Christian Medical College, Vellore  Department of Neurological Sciences Christian Medical college Vellore (Ranipet Campus) Kilminnal Village Ranipet Tamil Nadu India 632517
Vellore
TAMIL NADU 
9894022395

sanjith@cmcvellore.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Amrita Institute of Medical Sciences  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Sample collection for SNP mutation Analysis and cost-effective analysis.  Type of Intervention- Genetic Analysis Description- Collection of blood samples from patients who are taking Apixaban or Rivaroxaban or Dabigatran for existing thromboembolic condition.The collected samples will be processed in the laboratory to extract DNA. The DNA will be analyzed using PCR technique. and the sequencing will be done using Sanger method. The SNPs checked are rs4148738 rs2231142,rs776746,rs8192935 rs2244613,rs71647871 ,rs2032582 and rs1045642. Cost-effectiveness analysis will also be conducted. Frequency- Sample will be collected only once. Duration- The study duration is for 3 years.Patients will be followed up at 3months, 6months and 1 year time points.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Inpatients and outpatients of Department of Stroke medicine and Adult cardiology
Patients with and without NOAC failure
 
 
ExclusionCriteria 
Details  History of any mechanical or prosthetic valve replacements
Patients on haemodialysis or waiting for any renal replacement surgery
Patients who are about to undergo any surgery
Patients with congenital coagulation abnormalities
Patients who are not willing to participate in the study
Patients/caregivers who are unwilling to sign the informed consent
Pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of single nucleotide polymorphisms (SNP) associated with ineffective drug response among patients receiving NOACs for anticoagulation therapy.  Six months 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To establish genetic profiling test for appropriate NOACs for thrombosis prevention with minimal adverse complications (effective NOAC based on individual genomic conditions).
 
Six months 
To identify key etiological factors for ineffective anticoagulation in patients taking NOAC.
 
Six months 
To assess a cost-effectiveness analysis of pharmacogenomic-guided dosing strategy.  Baseline, 3months, 6 months & 1 year. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/01/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Thrombosis forms the primary pathological basis for disease conditions like stroke, venous thromboembolism (VTE) and acute coronary syndrome. Novel Oral Anticoagulants (NOACs) are used for stroke prevention in AF patients, as well as in the management of deep vein thrombosis (DVT) and pulmonary embolism (PE). Despite their widespread acceptance, challenges persist in understanding factors that influence their efficacy and safety profiles in diverse patient populations. NOACs exhibit pharmacokinetic and pharmacodynamic variability influenced by factors such as age, renal function, genetic polymorphisms, and drug interactions, posing challenges in achieving optimal anticoagulation and minimizing the risk of bleeding complications.

The existing knowledge on NOACs in stroke prevention and thrombosis management lacks comprehensive insights into pharmacogenomic variations, which are very relevant to recurrent thromboembolic and hemorrhagic events. Existing GWAS studies on the topic are not providing an adequate amount of information on genetic loci and SNPs influencing drug metabolism and inter-individual variabilities, giving scope for further research. Integration of clinical and genetic data provides a thorough assessment of NOAC effectiveness, enabling clinicians to personalize therapy based on individual patient characteristics and preferences. Pharmacogenomic insights can inform personalized dosing strategies, minimizing the risk of adverse events and better therapeutic outcomes.

The trial, which is a first of its kind in India, introduces an innovative approach by combining clinical and genetic insights to construct a personalized prediction model for NOAC therapy in patients with thromboembolic events. Prediction model will help in providing tailored treatment approaches with improved efficacy, making a significant change in clinical practice.A cost-effectiveness analysis will be performed to assess the impact of a pharmacogenomic-guided dosing strategy for Novel Oral Anticoagulants (NOACs). This will provide valuable insights into potential cost savings in the healthcare system. The analysis will include both direct medical costs (such as hospitalization, diagnostic tests, treatment costs) and indirect costs (loss of productivity, caregiver burden, etc.) among patients experiencing NOAC failure and those without failure. 

 
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