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CTRI Number  CTRI/2020/06/025708 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 13/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney disease  
Scientific Title of Study   Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) 
Trial Acronym  TRACK 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT03969953  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivekanand Jha 
Designation  Executive Director 
Affiliation  George Institute for Global Health, India 
Address  George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi, India

New Delhi
DELHI
110025
India 
Phone  8527544733  
Fax    
Email  vjha@georgeinstitute.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivekanand Jha 
Designation  Executive Director 
Affiliation  George Institute for Global Health, India 
Address  George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi, India

New Delhi
DELHI
110025
India 
Phone  8527544733  
Fax    
Email  vjha@georgeinstitute.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vivekanand Jha 
Designation  Executive Director 
Affiliation  George Institute for Global Health, India 
Address  George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi, India

New Delhi
DELHI
110025
India 
Phone  8527544733  
Fax    
Email  vjha@georgeinstitute.org.in  
 
Source of Monetary or Material Support  
National Health & Medical Research Council of Australia (NHMRC) 16 Marcus Clarke St, Canberra ACT 2601, Australia 
 
Primary Sponsor  
Name  George Institute for Global Health 
Address  George Institute for Global Health Level 5, 1 King Street Newtown NSW 2042 Australia  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Australia
China
India
Malaysia  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurabh Nayak  AIIMS, Raipur  Department of Nephrology, AIIMS, Raipur Great Eastern Rd, AIIMS Campus, Tatibandh, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 
9878943178

saurabhnayak2012@gmail.com 
Dr Dipankar Sircar  IPGME&R and SSKM Hospital  Department of Nephrology, IPGME&R and SSKM Hospital, AJC Bose Road Kolkata West Bengal- 700020
Kolkata
WEST BENGAL 
9433407355

deepsircar@gmail.com 
Dr Shankar Prasad Nagaraju  Kasturba Medical College  Department of Nephrology, Kasturba Medical College, MAHE,Tiger Circle Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 
9739905443

shankar.prasad@manipal.edu 
Dr Umapati Narasinha Hegde  Muljibhai Patel Urological hospital  Dr. Virendra Desai Road, Nadiad, Gujarat, India- 387001
Kheda
GUJARAT 
9426043141

umapatih@gmail.com 
Dr Sashidhar Chennamsetty  Nephrocare Health Services Pvt Ltd, Government Hospital,Nandyal  NGO Colony, Nandyal, Andhra Pradesh, India- 518501
Kurnool
ANDHRA PRADESH 
9652013437

Nephrosas@yahoo.co.in 
DrSashidhar Chennamsetty  Nephrocare Health Services Pvt Ltd, Government Hospital,Proddatur  Dastagiripet, Nadimpalli, Proddatur, Andhra Pradesh, India- 516362
Cuddapah
ANDHRA PRADESH 
9652013437

Nephrosas@yahoo.co.in 
DrIlangovan Veerappan  Nephrocare Health Services Pvt Ltd, KG Hospital  Nephrocare Health Services Pvt Ltd, K Govindswamy Naidu medical trust, Arts college road, Coimbatore, Tamil Nadu, India- 641 018
Coimbatore
TAMIL NADU 
8754025648

ilangovanv@gmail.com 
Dr Suresh Sankar  Nephrocare Health Services Pvt Ltd, VS Hospital  815/306, Poonamallee High Road, Kilpauk Chennai, India-600010
Chennai
TAMIL NADU 
9840482841

suresh.sankar@nephroplus.com 
Dr Seerapani Gopaluni   Nephrocare health services Pvt Ltd., Citizens Hospital  1-100/1/CCH, Near Aparna Sarovar, Seri-lingampally, Telangana 500019
Hyderabad
TELANGANA 
9963353209

drpanigopaluni@gmail.com 
Dr Avinash Ignatius  Nephrocare health services Pvt Ltd., Noble Annex Hospital  153, Second Floor, Siddhi Arcade, Magarpatta City Road, Hadapsar.  Pune Maharashtra,411013
Pune
MAHARASHTRA 
9823101982

avinash.ignatius@nephroplus.com 
Dr Balaraman V  Nephrocare health services Pvt Ltd.,Aysha Hospital,  91-A, Millers Road, Kilpauk.  Chennai Tamil Nadu, 600010
Chennai
TAMIL NADU 
9444031891

balammc87@hotmail.com 
Dr D Sree Bhushan Raju  Nizam Institute of Medical Sciences  Department of Nephrology, Unit II, 1st floor, acute renal care unit,Punjagutta, Hyderabad,Telangana, India- 500082
Hyderabad
TELANGANA 
9848492951

sreebhushan@hotmail.com 
Dr Manisha Sahay  Osmania General Hospital  Department of Nephrology,3rd Floor,QQDC Building, Afzalgunj, Hyderabad, Telangana, India- 500012
Hyderabad
TELANGANA 
9849097416

drmanishasahay@gmail.com 
Dr Raja Ramachandran  Postgraduate Institute of Medical Education and Research  Department of Nephrology, Ground floor, Block F, PGIMER, Madhya Marg,Sector 12, Chandigarh, India-160012
Chandigarh
CHANDIGARH 
9216958874

drraja1980@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Institutional Ethics Committee , KMC Manipal  Approved 
Institutional Ethics Committee - IPGMER  Approved 
Institutional Ethics Committee AIIMS, Raipur  Approved 
Institutional Ethics Committee NIMS  Approved 
Institutional Ethics Committee Osmania Medical College  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research  Approved 
The George Institute Ethics Committee   Approved 
The George Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z992||Dependence on renal dialysis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo   Dose: 2.5mg , dose Frequency: Twice daily Route Of administration: Oral Duration Of therapy: Depends on the time of randomization of participant (24 to 60 months) 
Intervention  rivaroxaban  Dose: 2.5mg , dose Frequency: Twice daily Route Of administration: Oral Duration Of therapy: Depends on the time of randomization of participant (24 to 60 months)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age ≥18 years
2. ESKD on haemodialysis or peritoneal dialysis, OR CKD stage 4 or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement therapy
3. Elevated CV risk, defined by at least one of the following: a. History of Coronary artery disease(CAD) or Peripheral artery disease(PAD) or non-haemorrhagic non-lacunar stroke, OR b. Diabetes mellitus, OR c. Age ≥65 years 
 
ExclusionCriteria 
Details  Potential participants must have NONE of the following exclusion criteria at the time of study
enrolment
1.Mechanical/prosthetic heart valve,
2.Indication for, or contraindication to, anticoagulant therapy
3.High bleeding risk including any coagulopathy
4.Lesion or condition considered to be a significant risk of major bleeding,
5. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically
significant bleeding,
6. Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors
(clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole),
where the treating physician or patient does not wish to stop these medications
7. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4
8. Any stroke within 1 month
9. Any previous history of a haemorrhagic or lacunar stroke
10. Severe heart failure with known ejection fraction <30% or NYHA class III or IV symptoms
11.History of hypersensitivity or known contraindication to rivaroxaban
12.Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg) at the time of screening
13. Haemoglobin <90 g/L, or platelet count <100 x 109/L
14. Significant liver disease or ALT >3 times upper normal limit
15.Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery
16.Pregnancy or intention to become pregnant or breast-feeding
17.Inability to understand or comply with the requirements of the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary a composite of cardiovascular death, non-fatal myocardial infarction, stroke, and peripheral artery disease event.  From baseline till end of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Individual components of the composite outcomes, all-cause death.
Safety: Major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH), fatal bleeding, non-fatal symptomatic intracranial haemorrhage (ICH), nonfatal, non-ICH, symptomatic bleeding into critical organ, site of major bleeding. 
From baseline till end of the study 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="600" 
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 3 
Date of First Enrollment (India)
Modification(s)  
01/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
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)?  

Brief Summary  

People with advanced kidney disease have high rates of heart and vascular disease. There are few treatments that are proven to improve the health of these patients. The purpose of this research study is to find out whether a low dose of blood thinning medication (rivaroxaban 2.5 mg twice daily) can reduce heart and vascular disease (such as heart attack and stroke), which are very common in people with advanced kidney disease. This dose of rivaroxaban is half the dose required to achieve the full blood-thinning effect at this level of kidney function.

Blood thinning medicines such as the study medication, have been proven and are frequently used to help people who are at high risk of heart and vascular disease. Because blood thinning medications prevent blood clots, these medications also increase the risk of bleeding. In the general population the benefit of blood thinning medication is greater than the harms of these medications (such as increased bleeding).

With this research we hope to learn whether the blood thinning medicine, low-dose rivaroxaban, has more benefits than harms in preventing heart and vascular disease in people with advanced kidney disease.

As part of this study, participants will receive either low-dose rivaroxaban tablets (the blood thinning medicine) or a placebo. Participants will be randomly assigned to receive either the rivaroxaban or the placebo. This study is a ‘double blind trial’, so neither participant nor the  treating doctor (or the other staff in the hospital) will know which tablet (rivaroxaban or placebo) the participant is  being given.

The study medication at low dose (rivaroxaban 2.5mg) is approved by medicine regulatory bodies in the USA, Europe, Canada and Australia, for the prevention of heart and vascular disease in people with normal kidney function or mild to moderate kidney disease, but it is not specifically approved in people with advanced kidney disease. This trial is designed to see if the medication is beneficial to patients with advanced kidney disease.

The study will run across many sites in Australia and overseas, and will include about 2,000 participants. The study will last about 5 years but many participants will be in the study for between 2 to 3 years, depending on when they join the study in the 5-year period.

 
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