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CTRI Number  CTRI/2021/08/035826 [Registered on: 19/08/2021] Trial Registered Prospectively
Last Modified On: 18/08/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Study on use of rivaroxaban along with aspirin in the management of coronary heart disease problem 
Scientific Title of Study   Rivaroxaban with Aspirin in Stable Cardiovascular Disease: An Observational Study in Indian Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Viveka Kumar 
Designation  Principal Director and Chief Cath Labs  
Affiliation  Max Super Speciality Hospital 
Address  Saket A Unit of Devki Devi Foundation 2 Press Enclave Saket New Delhi

South
DELHI
110017
India 
Phone  9871001190  
Fax  01126515050  
Email  viveka.kumar@maxhealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Viveka Kumar 
Designation  Principal Director and Chief Cath Labs  
Affiliation  Max Super Speciality Hospital 
Address  Saket A Unit of Devki Devi Foundation 2 Press Enclave Saket New Delhi

South
DELHI
110017
India 
Phone  9871001190  
Fax  01126515050  
Email  viveka.kumar@maxhealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr Viveka Kumar 
Designation  Principal Director and Chief Cath Labs  
Affiliation  Max Super Speciality Hospital 
Address  Saket A Unit of Devki Devi Foundation 2 Press Enclave Saket New Delhi

South
DELHI
110017
India 
Phone  9871001190  
Fax  01126515050  
Email  viveka.kumar@maxhealthcare.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Viveka Kumar 
Address  Max Super specialty Hospital (East Block) 2 Press Enclave Road Saket New Delhi  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rajesh Saxena  Max Super Speciality Hospital  Department of Cardiology Saket A Unit of Devki Devi Foundation 2 Press Enclave Saket New Delhi South DELHI 11001 7 India
South
DELHI 		 9818474003
01126515050
rajesh.saxena@maxhealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Service Floor, office of Ethics Committee, East Block, Near to Conference Room Max Super speciality Hospital Saket A Unit of Devki Devi Foundation 2 Press enclave Road Saket, New Delhi-110017   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antiplatelet therapy   Either aspirin or aspirin along with other anti-platelet drugs (dual antiplatelet therapy) for 1 year of duration 
Intervention  Rivaroxaban plus antiplatelet therapy  Tablet rivaroxaban 2.5 mg twice daily along with aspirin (75-100 mg) once daily for 1 year of duration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Willing and able to provide written informed consent
2. Age >18 years, either gender and known case stable coronary artery disease (CAD)
3. Patient at high risk for atherothrombosis
4. Patient eligible for dual pathway therapy (Rivaroxaban plus Aspirin) based on clinical judgement and receiving the same
 
 
ExclusionCriteria 
Details  1. Clinically considered high risk of bleeding
2. Presence of gastrointestinal bleed
3. Stroke within 1 month or any history of hemorrhagic or lacunar stroke
4. Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms
5. Estimated glomerular filtration rate (eGFR)<15 mL/min
6. Clinically requiring dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
7. History of hypersensitivity or known contraindication for rivaroxaban, aspirin, or excipients, if applicable.
8. Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (P-gp) (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine.
9. Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage risk reduction in the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with CAD  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
The primary safety outcome will be a composite of:
 Fatal bleeding, and/or
 Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, or bleeding into the surgical site requiring re-operation, and/or
 Bleeding leading to hospitalization
 Hospitalization
 Adverse events
 		 1 Year 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   23/08/2021 
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)   Not Applicable 
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  

Novel oral anticoagulants 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 rivaroxaban along with aspirin in patients with stable CAD. This will be a prospective observational study to compare the real world effectiveness and safety of patients with rivaroxaban with aspirin therapy vs patients on aspirin therapy alone. Up to 200 patients from single site (Max Hospital, Saket, Delhi) will be enrolled and followed for efficacy and safety outcomes for a period of 52 weeks. 

 
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