| 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
|
|
|
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
|
|
|
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. |