| CTRI Number |
CTRI/2017/10/010059 [Registered on: 12/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Rivaroxaban versus Fondaparinux Observational Study for Thromboprophylaxis
After Hip or Knee Arthroplasty
|
|
Scientific Title of Study
|
Rivaroxaban versus Fondaparinux Observational Study for Thromboprophylaxis after Hip or Knee Arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M A V V Prasad |
| Designation |
Senior Consultant |
| Affiliation |
VIJAYA SUPER SPECIALITY HOSPITAL |
| Address |
Room No.10, ground floor,
16 II/41-A, Pogathota,
S2 Cine Complex Road, Nellore, Andhra Pradesh
Nellore
ANDHRA PRADESH
524001
India |
| Phone |
|
| Fax |
|
| Email |
projectspcr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Executive Director |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Room No.1, #rd floor,
East Avenue,Plot No:319 and 320,Swamy Ayappa Society,
Madhapur
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
040-64581006 |
| Fax |
|
| Email |
hnandigala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Executive Director |
| Affiliation |
Virchow Biotech Private Limited |
| Address |
Room No.1, 3rd Floor, East Avenue,Plot No:319 and 320,Swamy Ayappa Society,
Madhapur
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
040-64581006 |
| Fax |
|
| Email |
hnandigala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Virchow Biotech Private Limited
|
|
|
Primary Sponsor
|
| Name |
Virchow Biotech Private Limited |
| Address |
East Avenue,Plot No:319 & 320,3rd Floor,Swamy Ayappa Society,Madhapur,hyderabad,Andhara Pradesh,India-500081. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Murali Kumar |
Chinmaya Mission Hospital, |
1/1, CMH Road, Opp. Krishna Temple,
Indiranagar, Bengaluru, Karnataka 560038
Bangalore
KARNATAKA |
9739993024
sattiraju.80@gmail.com |
| Dr VM Shetty |
City hospital |
1st floor central plaza, Above Central Bank of India,
N.S.S.Rd., Vishnu Nagar, Dombivli (W), Maharashtra
Washim
MAHARASHTRA |
02512495332
clinicals@virchowbiotech.com |
| Dr Vashisht Clinic |
Dr Vashisht Clinic |
Dr Vashisht Clinic
B-35, Shivalik, Basant Kumar Marg, Opp Malviya Nagar, New Delhi
New Delhi
DELHI |
01126691177
vishaly@virchowbiotech.com |
| Dr Asish Chobey |
East End Hospital |
East End Hospital
1208/737 deshpande layout, CA Road Nagpur
Nagpur
MAHARASHTRA |
07122736294
magevenki@gmail.com |
| Dr Zulfikar Patel |
Fatima Orthopedic & Physiotherapy Hospital |
Near,Anmber Today,Juhapura, Ahmedabad-380055
Ahmadabad
GUJARAT |
9601276972
nrshkmr146@gmail.com |
| Dr Sushanth MV |
Kasturi Multispeciality Hospital |
10-3-167/A, St.Johns, Lane Opp. Keys High School,
Secunderabad-500025
Hyderabad
ANDHRA PRADESH |
9989691223
kongabilwakshi@gmail.com |
| Dr Naveen D |
NDR Medullar Center |
Near yelahanka Bus stand Yelahanka, Bangalore
Bangalore
KARNATAKA |
9620718225
umeshreddy5255@gmail.com |
| Dr Piyush Dhavale |
Sukhkarta hospital |
plot no 26,malghi nagar, Thane, Maharashtra, Nagpur.
Nagpur
MAHARASHTRA |
07126459880
tcraghuram@gmail.com |
| Dr RS Subramanian |
Sushrusha ortho and spine Care hospital |
YK tower, ajni square, wardha road, Nagpur, Maharashtra
Nagpur
MAHARASHTRA |
9922427773
kavitareddy9@gmail.com |
| Dr M A V V Prasad |
VIJAYA SUPER SPECIALITY HOSPITAL |
16 II/41-A, Pogathota, Complex Road, Nellore, Andhra Pradesh 524001
Nellore
ANDHRA PRADESH |
8096368108
projectspcr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vijaya ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z471||Aftercare following joint replacement surgery, Patients undergoing elective knee or hip surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or Female patients who are undergoing elective hip or knee replacement surgery |
|
| ExclusionCriteria |
| Details |
Patients with active bleeding or a high risk of bleeding that contraindicated the use of rivaroxaban ;
Other exclusion criteria included conditions preventing bilateral venography, clinically significant liver, cardiac, renal disease, concomitant use of protease inhibitors of the human immunodeficiency virus or fibrinolytic agents, planned intermittent pneumatic compression, requirement of ongoing anticoagulant therapy, and pregnancy or breast-feeding.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any Major Bleeding |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any Minor Bleeding |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An observation study comparing rivaraxoban with different standard anticoagulants for symptomatic thromboembolism in patients undergoing elective hip or knee replacement surgery |