| CTRI Number |
CTRI/2022/01/039597 [Registered on: 20/01/2022] Trial Registered Prospectively |
| Last Modified On: |
08/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Post- approval Phase IV (Post-Market Clinical Follow-Up study) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess safety and effectiveness of Rivaroxaban(Xarelto)in managing coronary and or symptomatic peripheral artery disease in Indian Patients |
|
Scientific Title of Study
|
A phase IV study to investigate the safety and
effectiveness of Rivaroxaban(Xarelto) 2.5mg(BID plus
Acetylsalicylic Acid (ASA) 75 mg OD in Indian patients
with coronary and or symptomatic peripheral artery disease |
| Trial Acronym |
RIVACA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21269 v.2.0 dated 07/09/2020 |
Protocol Number |
| NCT04298567 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinisha Saldanha |
| Designation |
Senior Medical Advisor |
| Affiliation |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Bayer Zydus Pharma Private Limited
Research & Development Pharmaceuticals
Bayer House Central Avenue
400607 Thane Maharashtra
India
Thane
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
vinisha.saldanha@bayer.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinisha Saldanha |
| Designation |
Senior Medical Advisor |
| Affiliation |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Bayer Zydus Pharma Private Limited
Research & Development Pharmaceuticals
Bayer House Central Avenue
400607 Thane Maharashtra
India
Thane
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
vinisha.saldanha@bayer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinisha Saldanha |
| Designation |
Senior Medical Advisor |
| Affiliation |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Bayer Zydus Pharma Private Limited
Research & Development Pharmaceuticals
Bayer House Central Avenue
400607 Thane Maharashtra
India
Thane
MAHARASHTRA
400607
India |
| Phone |
|
| Fax |
|
| Email |
vinisha.saldanha@bayer.com |
|
|
Source of Monetary or Material Support
|
| Bayer Zydus Pharma Pvt.Ltd |
|
|
Primary Sponsor
|
| Name |
Bayer Zydus Pharma Pvt Ltd |
| Address |
Bayer Zydus Pharma Private Limited
Research & Development, Pharmaceuticals
Bayer House, Central Avenue
400607 Thane, Maharashtra
India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash Hazra |
AMRI Hospitals |
AMRI Hospital, P-4&5, Gariahat Road Block-A, Scheme-L11, Dhakuria Kolkata,700029 (India)
Kolkata
WEST BENGAL |
9830070337
prakashhazra@hotmail.com |
| Dr Ramakrishna Pinjala |
Apollo Hospitals |
ApolloResearch andInnovations,
Apollo HealthCity, Jubilee Hills,Hyderabad, Telangana-500096, India.
Hyderabad
TELANGANA |
9848050243
pinjala@hotmail.com |
| Dr Venugopal Balaji |
Apollo Hospitals |
21 Greams Lane, Off,
Greams Road,
Chennai-600006, Tamil
Nadu, India
Chennai
TAMIL NADU |
9841072234
jveebalaji@yahoo.co.in |
| Dr Satishkumar Kolekar |
B J G Medical college and Sassoon General Hospital |
Station Rd, Agarkar Nagar, Pune, Maharashtra
Pune
MAHARASHTRA |
9619284398
drkolekar.research@gmail.com |
| Dr Dhiman Kahali |
B M Birla Heart Research Center |
1/1, NationalLibrary Avenue,Kolkata-700027,West Bengal, India
Kolkata
WEST BENGAL |
9830048563
dhiman.kahali@gmail.com |
| Dr Premchand Dulichand Gupta |
Care Hospitals |
RdNumber 1,
Prem Nagar,Banjara Hills,Hyderabad, Telangana500034
Hyderabad
TELANGANA |
9848053220
vasculartherapy@gmail.com |
| Dr Anish Chandarana |
CIMS HOSPITAL PVT LTD. |
OPP.PANCHAMRUT BUNGLOWS,NR.SHUKAN MALL,OFF.SCIENCE CITY ROAD,SOLA,AHMEDABAD.380060
Ahmadabad
GUJARAT |
9825096922
anish.chandarana@cimshospital.org |
| Dr Shireesh Sathe |
Deenanath Mangeshkar Hospital and Research Centre |
Research Department,
Deenanath Mangeshkar
Hospital and Research
Centre, Off Karve Road,
Erandawane, Pune-
411004, Maharashtra, India
Pune
MAHARASHTRA |
020-49153271
shireesh.sathe@gmail.com |
| Dr Pradeep Deshmukh |
Government Medical College and Super Speciality Hospital |
Tukdoji Square, Nagpur, 440009 (India)
Nagpur
MAHARASHTRA |
9823057346
pradeepti2001@yahoo.com |
| Dr Govindan Vijayaraghavan |
Kerala Institute of Medical Sciences |
P. Box No. 1,Poonthi Road, AnayaraPO, Trivandrum-695029,Kerala, India
Thiruvananthapuram
KERALA |
9946843141
kims.remedy@gmail.com |
| Dr Prafulla Kerkar |
King Edward Memorial VII Hospital & Seth Gordhandas Sunderdas Medical College |
4th Floor,CVTC
Building,Department of
Cardiology,Acharya Donde Marg,Parel
400012,Mumbai,Maharashtra,India
Mumbai
MAHARASHTRA |
9821044111
prafullakerkar@rediffmail.com |
| Dr Kumud Rai |
Max Super Speciality Hospital Saket ( A unit of Devki Devi Foundation) |
2, Press Enclave Road, Saket, New Delhi-110017
New Delhi
DELHI |
9810205525
kumud.rai@maxhealthcare.com |
| Dr Robbie K George |
Narayana Health Hospital |
No.258/A,Bommasandra
Industrial area, Hosur Road,
Anekal taluk
Bangalore 560099, India
Bangalore
KARNATAKA |
9538896751
drrobbiegeorge@gmail.com |
| Dr Dhanesh Kamerkar |
Ruby Hall Clinic |
40,Sasoon Rd, Sangamvadi,Pune, Maharashtra411001
Pune
MAHARASHTRA |
9822041808
dhaneshkamerkar@gmail.com |
| Dr Kamal Sharma |
Sanjivani Super Speciality Hospital Pvt Ltd |
1, Uday Park Society,
Near Sunrise park,
Vastrapur, Ahmedabad,
Gujarat - 380015
Ahmadabad
GUJARAT |
9426020154
kamalsharma1975@rediffmail.com |
| Dr Jitendra Pal Singh Sawhney |
Sir Ganga Ram Hospital |
6th floor Clinical
Research room Dharam
Veera Heart Centre Old
Rajinder Nagar New
Delhi
New Delhi
DELHI |
9810059773
jpssawhney@yahoo.com |
| Dr Chandra Bhan Meena |
SMS Medical College and Hospital |
Department of Cardiology, Room No.208, BMRC, SMS Hospital, Jaipur- 302001, Rajasthan, India
Jaipur
RAJASTHAN |
8619445326
drcbhan@gmail.com |
| Dr Sandeep Bansal |
VMMC & Safdarjung Hospital |
Safdarjung campus, safdarjung,New Delhi, Delhi-110029
New Delhi
DELHI |
9810543368
Drsbansal2000@yahoo.com |
| Dr Rutvik Trivedi |
Zydus Hospitals & Healthcare Research Pvt. Ltd. |
Near Indira Gandhi statue Anand- Lambhvel Road, Anand, Gujarat, PIN - 388001
Anand
GUJARAT |
9825614079
rutviktrivedi78@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Deenanath Mangeshkar Hospital and Research Centre Institutional Ethics Committee |
Approved |
| Ethic Committee of CIMS |
Approved |
| Ethics Committee AMRI Hospital Ltd |
Approved |
| Ethics committee Sir Ganga Ram Hospital |
Approved |
| Ethics Committee SMS Medical College and Hospital |
Approved |
| Ethics Committee-Zydus Hospital |
Approved |
| Institute Ethics Committee VMMC and SJH, VMMC and Safdarjung hospital |
Not Applicable |
| Institutional Ethics Committe, Max Super Specialty Hospital, |
Approved |
| Institutional Ethics Committee B.M. Birla Heart Research Centre |
Approved |
| Institutional Ethics committee Care Hospital |
Approved |
| Institutional Ethics Committee, B.J.G Medical College and Sassoon General Hospital,Pune |
Approved |
| Institutional Ethics Committee,GMC,Nagpur |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE-CLINICAL STUDIES (IEC-CS) APOLLO HOSPITALS |
Approved |
| Institutional Ethics Committee-Clinical StudiesApollo Hospitals enterpriseLimited |
Approved |
| Institutional Ethics Committee-l Seth GS Medical College and KEM Hospital |
Approved |
| Institutional Human Ethics Committee Kerala Institute Of Medical Sciences |
Approved |
| Narayana Health Medical Ethics Committee |
Approved |
| Poona medical research foundation institutional ethics committee |
Approved |
| Sanjivani Hospital Ethics Committee Sanjivani Super Speciality Hospital Pvt.Ltd. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult (≥18 years) female or male patient
2. Diagnosis of CAD or PAD
3. Decision to treat the patient with Rivaroxaban 2.5mg [BID] , co-administered with ASA
75mg[OD], for the prevention of atherothrombotic events in adult patients with coronary
artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of
ischaemic events has been made by the investigator
4. Patient is willing to participate in the study (signed informed consent). |
|
| ExclusionCriteria |
| Details |
1. Patients with haemoglobin level less than 10 gm/dl
2. Patients with clinically significant active bleeding (e.g., intracranial bleeding, gastrointestinal
bleeding).
3. Patients with hepatic disease which is associated with coagulopathy leading to a clinically
relevant bleeding risk
4. In patients with severe renal impairment (Cr Cl<15 ml/min)
5. Patients with a history of GI bleeding
6. CAD or PAD patients with previous haemorrhagic or lacunar stroke
7. History of hypersensitivity or known contraindication for rivaroxaban, aspirin
8. Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5
mg given for CAD/PAD.
9. Patient is a pregnant women and nursing mother
Participation in an investigational program with interventions outside of routine clinical
practice |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Number of participants with haemorrhagic events and complications [ Time Frame: Up to 13 months ]
Consisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization |
upto 13 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MACE: composite of MI, stroke, and cardiovascular death (and single components)
MALE: major adverse limb events, incl. major amputation (and single components)and
antithrombotic treatment patterns after MALE
Thromboembolic events (systemic embolism, VTE)
Cardiovascular mortality
All-cause mortality
Hospitalizations (and duration) for stroke, cardiovascular reasons, MALE, or bleeding
complications.
Total and pai free walking distance per individual for PAD patients
reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
clinical characteristics of CAD or PAD patients
use of antithrombotic treatment and other secondary prevention therapies (prior and
concomitant medication) in patients with CAD or PAD
reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
reasons for discontinuation of rivaroxaban 2.5 mg [BID]
planned and actual duration of treatment with rivaroxaban 2.5 mg [BID]
planned and actual duration of treatment with ASA 75 mg [OD]
|
upto 13 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
25/02/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The proposed study is a post authorization safety study that aims to collect the safety and effectiveness data on use of rivaroxaban 2.5 mg [BID] with ASA 75mg [OD] for the prevention of atherothrombotic events in adult patients in CAD or symptomatic PAD at high risk of ischaemic events and is a regulatory commitment to the Indian Health Authority. The study also aims to collect real-world data on treatment patterns and decision points for treatment with rivaroxaban 2.5 mg[BID] in patients with CAD or symptomatic PAD across the broad range of patient risk profiles encountered in routine clinical practice. A single arm design has been outlined as no other regimen has been approved in this specific CAD or symptomatic PAD population hence there is no suitable comparator available. The local study protocol needs to be submitted to the Indian Health Authority for approval. The primary objective in this study is: • To describe safety outcomes in CAD or PAD patients treated with rivaroxaban 2.5 mg [BID] plus ASA 75 mg [OD]. The secondary objectives in this study are:  To describe effectiveness outcomes in CAD or PAD patients treated with rivaroxaban 2.5 mg [BID] plus ASA 75 mg [OD]  To describe treatment patterns in CAD or symptomatic PAD patients treated with rivaroxaban 2.5 mg [BID] plus ASA 75mg [OD] |