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CTRI Number  CTRI/2021/05/033907 [Registered on: 31/05/2021] Trial Registered Prospectively
Last Modified On: 25/02/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Effect of Rivaroxaban in Coronary artery disease patients - Observational study 
Scientific Title of Study   INdian Real world EvidenCe Of Rivaroxaban use in coronary artery Disease – A prospective observational cohort study.  
Trial Acronym  IN-RECORD 
Secondary IDs if Any  
Secondary ID  Identifier 
EPL/RIV/21/001 version1 dated March 3, 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vikneswaran G 
Designation  Associate Consultant-Clinical Research 
Affiliation  Narayana Health City, Narayana Hrudayalaya Limited 
Address  Room No. 2, Department of Clinical Research, Narayana Health City, #258/A, Bommasandra Industrial area, Anekal Taluk, Bangalore Department of Clinical Research, Narayana Health, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9787649182  
Fax    
Email  vikneswaran.g.dr@narayanahealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Onkar Swami 
Designation  Director Medical Services 
Affiliation  Emcure Pharmaceuticals Limited 
Address  Emcure Pharmaceuticals Ltd. Phase-1, Rajiv Gandhi IT Park, M.I.D.C. Hinjwadi, Pune - 411057. India

Pune
MAHARASHTRA
411057
India 
Phone  9372413101  
Fax    
Email  onkar.swami@emcure.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Dhammadeep Dabhade 
Designation  Senior manager Medical services 
Affiliation  Emcure Pharmaceuticals Limited 
Address  Phase-1, Rajiv Gandhi IT Park, M.I.D.C. Hinjwadi, Pune - 411057.

Pune
MAHARASHTRA
411057
India 
Phone  9589786883  
Fax    
Email  dhammadeep.dabhade@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Ltd. Phase-1, Rajiv Gandhi IT Park, M.I.D.C. Hinjwadi, Pune - 411057. India 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Limited 
Address  255/2, Rajiv Gandhi IT Park, MIDC, Hinjawadi, Pune -411 057, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Sreenivas Kumar  Apollo Hospitals  Suite no. 3A, Ground Floor, Department of Cardiology, International block,Jubilee Hills, Hyderabad, Telangana 500033
Hyderabad
TELANGANA 		 9848046785

arramraj@yahoo.com 
Dr Rajendra Kumar Premchand   Krishna Institute of Medical Sciences  Block 3, 3rd floor, Room no. 59 Cardiology department, 1-8-31/1,Minister road, Secunderabad 500003,Telengana.
Hyderabad
TELANGANA 		 9848029443

kumarpre@hotmail.com 
Dr PB Jaigopal  Lakshmi Hospital  Room no. 3, Block A, Cardiology department, Ground Floor, Chittur Road, Palakkad-678013
Palakkad
KERALA 		 9847023777

jaigopallakshmi@gmail.com 
Dr Bagirath Raghuraman  Narayana Institute of Cardiac sciences, Narayana Hrudayalaya Limited  Department of Cardiology, Room no. 9 Ground floor. 258/A, Bommasandra Industrial area, Anekal taluk, Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9845144830

bagirath.raghuraman.dr@narayanahealth.org 
Dr Vinod Sharma  National Heart Institute  Room No.7, Ground Floor, Department of Cardiology,49-50, Community Centre, East of Kailash, New Delhi – 110065
South
DELHI 		 9810131739

drvs1994@rediffmail.com 
Dr Anup Khetan  NH-Rabindranath Tagore International Institute of Cardiac Science  Room 18-19, Ground Floor, Department of Cardiology, RTIICS Building, No. 124, Eastern Metropolitan Bypass, Premises No: 1489, Mukundapur, Kolkata- 700099,West Bengal
Kolkata
WEST BENGAL 		 9831080518

anup_khetan@rediffmail.com 
Dr Amitabh Yaduvanshi  Pushpawati Singhania Hospital Research Institute  Department of Cardiology, Room no 16,First Floor, Block B, Press Enclave Marg, Sheikh Sarai Phase-II, South Delhi,Delhi-110017
South
DELHI 		 9810794959

amitabhy@gmail.com 
Dr Suhas Prahlad Hardas  Sahyadri Super Speciality Hospital  Cathlab,2nd Floor, Department of Cardiology, Main Building, Plot No. 30-C, Erandwane, Karve Road, Deccan Gymkhana, Pune- 411004
Pune
MAHARASHTRA 		 9822008910

suhas_h@hotmail.com 
Dr Vilas Magarkar  Seth Nandlal Dhoot Hospital  Room no. 3, 1st floor,Cardiac Wing, A-1, MIDC, Chikalthana, Jalna Road, Aurangabad-431210
Aurangabad
MAHARASHTRA 		 9822094181

drvilas2007@gmail.com 
Dr J Ezhilan  The Madras Medical Mission  Department of Cardiology, L-04, 4A, Bazaar Rd, Dr. J J Nagar, Mogappair, Chennai, Tamil Nadu 600037
Chennai
TAMIL NADU 		 9444024639

icvddoctors@mmm.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Institutional Ethics Committee- All India Heart Foundation  Approved 
Institutional Ethics Committee- Biomedical Research  Approved 
Institutional Ethics Committee- The Madras Medical Mission  Approved 
KIMS ethics committee   Approved 
Lakshmi Hospital Institutional Ethics Committee  Approved 
Narayana Health Medical Ethics Committee  Approved 
NHRTIICS Ethics Committee  Approved 
PSRIEC  Approved 
Sahyadri Hospitals Private Ltd Ethics Committee  Approved 
Seth Nandlal Dhoot Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antiplatelet therapy alone  Either aspirin (75-100 mg) oral once daily or aspirin along with other anti-platelet drugs (dual antiplatelet therapy) dose as prescribed by the physician for one year 
Intervention  Rivaroxaban plus antiplatelet therapy  Tablet rivaroxaban 2.5 mg oral twice daily along with aspirin (75-100 mg) oral once daily for 1 year 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age >18 years, either gender having a diagnosis of coronary artery disease and meeting the following additional criteria
a. Taking antiplatelet therapy for coronary artery disease or peripheral artery disease
b. Having ≥2 vascular beds affected or eligible to take an oral anticoagulant therapy
2. Willing to provide written informed consent and for follow up of one year from the date of registration.  
 
ExclusionCriteria 
Details  1. Patients having a diagnosis of atrial fibrillation (valvular or non-valvular) prior to or at the time of index acute coronary event or diagnosis.
2. Patients on high doses of newer oral anticoagulants - ≥10mg per day.
3. Patients on vitamin K antagonist for any reason.
4. Patients not likely to cooperate for data collection and follow up – investigator’s decision. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of net clinical benefit between rivaroxaban with antiplatelet therapy group and antiplatelet therapy alone group.
Net Clinical Benefit will be a composite of effectiveness (reduction in incidence of cardiovascular death, stroke, MI) and safety (life threatening or fatal bleeding) 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Effectiveness of rivaroxaban with antiplatelet therapy vs antiplatelet therapy alone in reducing the compose outcomes (stroke, myocardial infarction, cardiovascular death)  1 year 
Incidence of major bleeding between rivaroxaban with antiplatelet therapy vs antiplatelet therapy alone  1 year 
Non inferiorityof rivaroxaban (Exafib) vs rivaroxaban (reference drug) on net clinical benefit   1 year 
Net clinical benefit will be compared between the 2 groups (rivaroxaban with antiplatelet therapyvs antiplatelet therapy alone) based on age group (less than 65 years vs more than 65 years); prior PCI, presence,or absence of comorbidities such as heart failure, diabetes mellitus, MI.  1 year 
Change in quality of life from baseline to 1 year assessed using SF-36 questionnaire.  1 year 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   08/06/2021 
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)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Direct oral anticoagulants (DOACs) are used to prevent thrombosis in several cardiac contexts such as atrial fibrillation, deep vein thrombosis etc. FDA in 2018, approved rivaroxaban for reduction of major adverse cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral arterial disease (PAD).The COMPASS published convincing evidence that supports the use of aspirin plus rivaroxaban in patients with stable coronary artery disease.  This will be a prospective observational study to compare the real world effectiveness and safety of patients with rivaroxaban with antiplatelet therapy vs patients on antiplatelet therapy alone. Up to 1000 patients  from multiple sites across India will be enrolled and followed for efficacy and safety outcomes for a period of 1 year. product) with antiplatelet therapy vs patients on antiplatelet therapy only. 
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