| 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
|
|
|
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
|
|
|
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 |