| CTRI Number |
CTRI/2022/05/042669 [Registered on: 19/05/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
efficacy and safety of non vitamin K anticoagulants compared to vitamin K anticoagulants in treatment of atrial fibrillation patients |
|
Scientific Title of Study
|
Clinical efficacy and safety of non vitamin K anticoagulants compared to vitamin K anticoagulants in treatment of atrial fibrillation patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSarumathyS |
| Designation |
Associate professor M.pharm , PhD |
| Affiliation |
Srm college of pharmacy |
| Address |
Thirumurugan nagar Pallavaram
SRM Institute of Science and Technology
Kancheepuram
TAMIL NADU
600117
India |
| Phone |
7010530419 |
| Fax |
|
| Email |
saruprabakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar TM |
| Designation |
M.Pharm.,Ph.D |
| Affiliation |
Srm college of pharmacy |
| Address |
Selliamman Koil Kattankulathur
SRM Institute of Science and Technology
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400350 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhandapani VE |
| Designation |
MBBS,M.D. (Gen. Medicine),D.M. (Cardiology) |
| Affiliation |
SRM Medical College Hospital & Research Centre |
| Address |
SRM Medical College Hospital and Research centre
SRM Institute of Science and Technology
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9443212121 |
| Fax |
|
| Email |
dhandapani.e@ktr.Srmuniv.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
srm college of pharmacy |
| Address |
srm institution of science and technology
kattankulathur - 603203 |
| 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 |
| Umas |
SRM Medical college hospital and research centre |
Department of Pharmacy Practice, SRM College of Pharmacy, SRMIST, kattankulathur
603203, Chengalpet DT
TAMIL NADU
Kancheepuram
TAMIL NADU |
9025281580
hemavarshen2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I489||Unspecified atrial fibrillation and atrial flutter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Warfarin 5 mg-10 mg OD |
Dabigatran 110mg BD
Study duration-6 months,
follow up at 3rd and 6th month. |
| Comparator Agent |
Warfarin 5mg-10mg OD
|
Rivoraxaban 10mg OD
Study duration-6 months, follow up at 3rd and 6th month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Atrial fibrillation patients |
|
| ExclusionCriteria |
| Details |
Patient with anitcoagulant therapy for a condition other than AF n
Pregnant and lactating women.
Patient with liver disease ( acute clinical hepatitis , chronic active hepatitis , cirrhosis ) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PT , INR Normal values indicate that patient is at lower risk of stroke . |
3 months once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is a significant risk of intracranial bleeding, GI bleeding in patients , GARFIELD - AF Score is used to asses this risk. |
6 months once |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
29/05/2022 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
STUDY SITE : Department of cardiology , SRM Medical collage hospital and research centre , kattankulathur , kancheepuram , tamilnadu.
STUDY DURATION : 6 months period from November 2021 - April 2022
METHODOLOGY :
STUDY DESIGN :Prospective observational study
SAMPLE SIZE : 120 patients GROUP A : 40 patients with warfarin 5 - 10 mg OD GROUP B : 40 patients with rivaroxaban 10mg OD GROUP C : 40 patients with dabigatran 110mg BD
VARIABLES TO BE STUDIED :
1. PT 2.INR ratio 3.GARFIELD AF score 4.ECG 5. CHAR’S Score
INCLUSION CRITERIA : patient with ATRIAL FIBRILLATION patients of both gender with age above 18 years Left venticle Ejection fraction - <50%
EXCLUSION CRITERIA : patient with anticoagulant therapy for a condition other than AF Pregnant and lactating womens patient with liver disease such as acute clinical hepatitis , chronic active hepatitis , cirrhosis. |