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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03969953




Registration number
NCT03969953
Ethics application status
Date submitted
27/05/2019
Date registered
31/05/2019

Titles & IDs
Public title
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Scientific title
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Secondary ID [1] 0 0
0040139
Universal Trial Number (UTN)
Trial acronym
TRACK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Diseases 0 0
Dialysis-dependent Kidney Failure 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban 2.5 Mg Oral Tablet
Other interventions - Placebo

Experimental: Rivaroxaban - Rivaroxaban 2.5mg, twice daily.

Placebo comparator: Placebo - Matched placebo, twice daily.


Treatment: Drugs: Rivaroxaban 2.5 Mg Oral Tablet
Rivaroxaban is an orally administered selective direct factor Xa inhibitor.

Other interventions: Placebo
Rivaroxaban matched placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Risk of Major Adverse Cardiac Event (MACE)
Timepoint [1] 0 0
5 years or trial closure
Secondary outcome [1] 0 0
Composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.
Timepoint [1] 0 0
5 years or trial closure
Secondary outcome [2] 0 0
Composite outcome of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.
Timepoint [2] 0 0
5 years or trial closure
Secondary outcome [3] 0 0
Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.
Timepoint [3] 0 0
5 years or trial closure
Secondary outcome [4] 0 0
Incidence of Cardiovascular Death
Timepoint [4] 0 0
5 years or trial closure
Secondary outcome [5] 0 0
Incidence of Non-Fatal Myocardial Infarction
Timepoint [5] 0 0
5 years or trial closure
Secondary outcome [6] 0 0
Incidence of Stroke
Timepoint [6] 0 0
5 years or trial closure
Secondary outcome [7] 0 0
Incidence of PAD Events
Timepoint [7] 0 0
5 years or trial closure
Secondary outcome [8] 0 0
Net Clinical Benefit - incidence of MACE & Bleeding
Timepoint [8] 0 0
5 years or trial closure
Secondary outcome [9] 0 0
Incidence of Venous Thromboembolism
Timepoint [9] 0 0
5 years or trial closure

Eligibility
Key inclusion criteria
* People able to provide informed consent who meet all of the following inclusion criteria:

1. Age =18 years,
2. Kidney Failure 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 cardiovascular risk, defined by at least one of the following:

1. History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
2. Diabetes mellitus, or
3. Age =65 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Potential participants must have none of the following exclusion criteria at the time of study enrolment:

1. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
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 prior to enrolment,
9. Any previous history of a haemorrhagic or lacunar stroke,
10. Severe heart failure with known ejection fraction <30% or New York Heart Association 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 (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) >3 times upper normal limit,
15. Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
16. All countries except Europe: Pregnancy or intention to become pregnant or breast-feeding; Europe only: Women who are not in a postmenopausal state, where postmenopausal is defined as no menses for 12 months without alternative medical causes,
17. Inability to understand or comply with the requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 0 0
St George Hospital - Kogarah
Recruitment hospital [5] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [8] 0 0
Logan Hospital - Meadowbrook
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [11] 0 0
Bendigo Health - Bendigo
Recruitment hospital [12] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [13] 0 0
Armadale Hospital - Armadale
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2747 - Kingswood
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2500 - Wollongong
Recruitment postcode(s) [8] 0 0
4131 - Meadowbrook
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
5000 - Adelaide
Recruitment postcode(s) [11] 0 0
3552 - Bendigo
Recruitment postcode(s) [12] 0 0
3021 - St Albans
Recruitment postcode(s) [13] 0 0
6112 - Armadale
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Hamilton
Country [2] 0 0
Canada
State/province [2] 0 0
Ottawa
Country [3] 0 0
France
State/province [3] 0 0
Meurthe-et-Moselle
Country [4] 0 0
France
State/province [4] 0 0
Ars-Laquenexy
Country [5] 0 0
France
State/province [5] 0 0
Boulogne-Billancourt
Country [6] 0 0
France
State/province [6] 0 0
Boulogne-sur-Mer
Country [7] 0 0
France
State/province [7] 0 0
Brest
Country [8] 0 0
France
State/province [8] 0 0
Colmar
Country [9] 0 0
France
State/province [9] 0 0
Haguenau
Country [10] 0 0
France
State/province [10] 0 0
Limoges
Country [11] 0 0
France
State/province [11] 0 0
Lyon
Country [12] 0 0
France
State/province [12] 0 0
Marseille
Country [13] 0 0
France
State/province [13] 0 0
Mulhouse
Country [14] 0 0
France
State/province [14] 0 0
Nice
Country [15] 0 0
France
State/province [15] 0 0
Pierre-Bénite
Country [16] 0 0
France
State/province [16] 0 0
Reims
Country [17] 0 0
France
State/province [17] 0 0
Strasbourg
Country [18] 0 0
France
State/province [18] 0 0
Tours
Country [19] 0 0
France
State/province [19] 0 0
Vandœuvre-lès-Nancy
Country [20] 0 0
India
State/province [20] 0 0
Chhattisgarh
Country [21] 0 0
India
State/province [21] 0 0
Gujarat
Country [22] 0 0
India
State/province [22] 0 0
Karnataka
Country [23] 0 0
India
State/province [23] 0 0
Pune Maharashtra
Country [24] 0 0
India
State/province [24] 0 0
Punjab
Country [25] 0 0
India
State/province [25] 0 0
Tamil Nadu
Country [26] 0 0
India
State/province [26] 0 0
Telangana
Country [27] 0 0
India
State/province [27] 0 0
Chandigarh
Country [28] 0 0
India
State/province [28] 0 0
Coimbatore
Country [29] 0 0
India
State/province [29] 0 0
Kilpauk
Country [30] 0 0
India
State/province [30] 0 0
Kolkata
Country [31] 0 0
India
State/province [31] 0 0
Nandyal
Country [32] 0 0
India
State/province [32] 0 0
Proddatur
Country [33] 0 0
India
State/province [33] 0 0
Saligramam
Country [34] 0 0
India
State/province [34] 0 0
Virugambakkam
Country [35] 0 0
Malaysia
State/province [35] 0 0
Kedah
Country [36] 0 0
Malaysia
State/province [36] 0 0
Kelantan
Country [37] 0 0
Malaysia
State/province [37] 0 0
Negeri Sembilan
Country [38] 0 0
Malaysia
State/province [38] 0 0
Penang
Country [39] 0 0
Malaysia
State/province [39] 0 0
Perak
Country [40] 0 0
Malaysia
State/province [40] 0 0
Sabah
Country [41] 0 0
Malaysia
State/province [41] 0 0
Selangor
Country [42] 0 0
Malaysia
State/province [42] 0 0
Wilayah Persekutuan
Country [43] 0 0
Saudi Arabia
State/province [43] 0 0
Riyadh
Country [44] 0 0
Singapore
State/province [44] 0 0
Singapore
Country [45] 0 0
Taiwan
State/province [45] 0 0
New Taipei City
Country [46] 0 0
Taiwan
State/province [46] 0 0
Kaohsiung
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taichung
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Taoyuan
Country [50] 0 0
Tunisia
State/province [50] 0 0
Monastir
Country [51] 0 0
Tunisia
State/province [51] 0 0
Sfax
Country [52] 0 0
Tunisia
State/province [52] 0 0
Sousse
Country [53] 0 0
Tunisia
State/province [53] 0 0
Tunis

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
George Clinical Pty Ltd
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Bayer
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centre Hospitalier Régional Universitaire de Nancy
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
King Abdullah International Medical Research Center
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sunil Badve
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sunil Badve
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4636
Fax 0 0
Email 0 0
sbadve@georgeinstitute.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.

Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
To be confirmed
Available to whom?
* No data should be released that would compromise the trial, unless specifically for safety reasons.
* There must be a strong scientific or other legitimate rationale for the data to be used for the requested purpose.
* TRACK Investigators should have a period of exclusivity in which to pursue their aims with the data, before key trial data are made available to other researchers.
* Adequate resources must be available in order to comply with the request, and the scientific aims of the study must justify the use of such resources.
* Data release complies with the relevant regulations from all relevant countries.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03969953