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Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK)

Primary Purpose

Chronic Kidney Diseases, Dialysis-dependent Kidney Failure, Cardiovascular Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban 2.5 Mg Oral Tablet
Placebo
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Rivaroxaban

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Canberra HospitalRecruiting
  • Concord Repatriation General HospitalRecruiting
  • Nepean HospitalRecruiting
  • St George HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • Royal North Shore HospitalRecruiting
  • Wollongong HospitalRecruiting
  • Logan HospitalRecruiting
  • Gold Coast University Hospital
  • Royal Adelaide HospitalRecruiting
  • Bendigo HealthRecruiting
  • Sunshine HospitalRecruiting
  • Armadale Hospital
  • Research St. Joseph's - Hamilton
  • Ottawa Hospital Research Institute
  • Centre Hospitalier Régional Universitaire de Nancy
  • Hôpital de Mercy, (CH Metz-Thionville)
  • Hôpital Ambroise Paré, (AP-HP)
  • CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)
  • Hôpital de la Cavale Blanche, (CHU Brest)
  • AURAL Colmar, (AURAL Colmar)
  • AURAL Haguenau, (AURAL Haguenau)
  • CH Haguenau, (CH Haguenau)
  • ALURAD Buisson, (ALURAD Buisson)
  • CHU Dupuytren, (CHU Dupuytren)
  • Hôpital Edouard Herriot, (CHU Lyon)
  • Hôpital de la Conception, (AP-HM)
  • AURAL Mulhouse, (AURAL Mulhouse)
  • CH Mulhouse, (CH Mulhouse)
  • Hôpital Pasteur, (CHU Nice)
  • Hôpital Lyon Sud, (CHU Lyon)
  • Hôpital de la Maison Blanche, (CHU Reims)
  • AURAL Strasbourg, (AURAL Strasbourg)
  • Hôpital Bretonneau, (CHRU Tours)
  • Hôpitaux de Brbaois, (ALTIR)
  • All India Institute Of Medical Sciences, RaipurRecruiting
  • Muljibhai Patel Urological HospitalRecruiting
  • Kasturba Medical College and Hospital, ManipalRecruiting
  • Noble Annex HospitalRecruiting
  • All India Institute of Medical Sciences, BathindaRecruiting
  • Aykai Super Speciality Hospital, LudhianaRecruiting
  • Aysha HospitalRecruiting
  • Osmania General HospitalRecruiting
  • Citizens HospitalRecruiting
  • Nizam's Institute of Medical Sciences, HyderabadRecruiting
  • Postgraduate Institute of Medical Education and Research, ChandigarhRecruiting
  • KG Hospital, K.Govindaswamy Naidu Medical TrustRecruiting
  • VS HospitalRecruiting
  • Institute of Post-Graduate Medical Education and ResearchRecruiting
  • Government HospitalRecruiting
  • Government HospitalRecruiting
  • Sooriya Hospital
  • L & T Prayas Medical Centre
  • Hospital Sultanah BahiyahRecruiting
  • Hospital Raja Perempuan Zainab IIRecruiting
  • Hospital Tuanku Ja'afar, SerembanRecruiting
  • Hospital Seberang JayaRecruiting
  • Hospital Raja Permaisuri Bainun, IpohRecruiting
  • Hospital Queen Elizabeth, Kota KinabaluRecruiting
  • Hospital KajangRecruiting
  • Hospital Canselor Tuanku MuhrizRecruiting
  • University of Malaya Medical CentreRecruiting
  • Hemodialysis Care Project North CentreRecruiting
  • Hemodialysis King Abdullah CentreRecruiting
  • ialysis Centre - King Abdul Aziz Medical City (KAMC)Recruiting
  • Hemodialysis Care Project South CentreRecruiting
  • King Abdullah International Medical Research Center
  • Tan Tock Seng HospitalRecruiting
  • Khoo Teck Puat HospitalRecruiting
  • Fu-Jen Catholic University HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Kaohsiung Chang-Gung Memorial Hospital
  • Chung-Shan Medical University Hospital
  • Wan fang HospitalRecruiting
  • Taipei Tzu Chi Hospital
  • Chang Gung Memorial Hospital, Linkou Medical Center
  • Fattouma Bourguiba HospitalRecruiting
  • Hedi chaker Hospital
  • Sahloul HospitalRecruiting
  • Charles Nicolle HospitalRecruiting
  • La Rabta HospitalRecruiting
  • Military HospitalRecruiting
  • Mongi Slim HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rivaroxaban

Placebo

Arm Description

Rivaroxaban 2.5mg, twice daily.

Matched placebo, twice daily.

Outcomes

Primary Outcome Measures

Risk of Major Adverse Cardiac Event (MACE)
To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of; CV death, non-fatal myocardial infarction, stroke, or peripheral artery disease (PAD) events

Secondary Outcome Measures

Composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.
To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.
Composite outcome of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.
To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.
Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.
To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, or stroke.
Incidence of Cardiovascular Death
To determine whether the intervention, compared to placebo, changes the risk of Cardiovascular Death
Incidence of Non-Fatal Myocardial Infarction
To determine whether the intervention, compared to placebo, changes the risk of Non-Fatal Myocardial Infarction
Incidence of Stroke
To determine whether the intervention, compared to placebo, changes the risk of Stroke
Incidence of PAD Events
To determine whether the intervention, compared to placebo, changes the risk of PAD events
Net Clinical Benefit - incidence of MACE & Bleeding
To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, stroke, PAD events, fatal bleeding, or symptomatic bleeding into a critical organ.
Incidence of Venous Thromboembolism
To determine whether the intervention, compared to placebo, changes the risk of Venous Thromboembolism

Full Information

First Posted
May 27, 2019
Last Updated
August 8, 2022
Sponsor
The George Institute
Collaborators
George Clinical Pty Ltd, Bayer, Centre Hospitalier Régional Universitaire de Nancy, King Abdullah International Medical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03969953
Brief Title
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Acronym
TRACK
Official Title
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The George Institute
Collaborators
George Clinical Pty Ltd, Bayer, Centre Hospitalier Régional Universitaire de Nancy, King Abdullah International Medical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited. The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).
Detailed Description
Background and Rationale Chronic Kidney Disease (CKD) is a major international health burden. Despite the unacceptably high burden of cardiovascular disease (CVD) and associated mortality, trial-data on the management of CVD in people with advanced stages of CKD and dialysis-dependent kidney failure are sparse. Risk of bleeding in CKD and dialysis-dependent kidney failure is increased when compared to the general population. Anticoagulant agents, such as rivaroxaban, are a core intervention in the prevention of CVD in the general population. Nevertheless, to mitigate trial risks, 90% of the trials evaluating this form of intervention exclude these patient populations. The TRACK trial will evaluate the effect of low dose rivaroxaban in patients with CKD dialysis-dependent kidney failure. Other trials have demonstrated that rivaroxaban reduces the risk of major cardio-vascular outcomes in high risk patients, and the limited data showed that CKD status did not significantly affect this result. Hypothesis Compared to placebo, low dose rivaroxaban reduces the risk of major adverse cardiac event (MACE) in people with CKD stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years). Objectives The primary objective is to determine whether low dose rivaroxaban, compared to placebo, significantly reduces the risk of a composite outcome of; CV death, non-fatal myocardial infarction, stroke, or peripheral artery disease (PAD) events in people with CKD stages 4 or 5 or dialysis-dependent kidney failure, and an elevated CV risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years). A full list of secondary objectives are detailed in the protocol, and include identifying risk reduction in the treatment group, and whether this treatment is cost effective. Methodology The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. The trial will test for the superiority of the trial intervention using a 1:1 allocation to parallel trial groups, on the basis of a pre-specified number of primary outcomes events. This is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2,000 participants will be recruited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Dialysis-dependent Kidney Failure, Cardiovascular Disease
Keywords
Rivaroxaban

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. The trial will test for the superiority of the trial intervention using a 1:1 allocation to parallel trial groups, on the basis of a pre-specified number of primary outcomes events.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple-blind, Placebo-controlled
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban
Arm Type
Experimental
Arm Description
Rivaroxaban 2.5mg, twice daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo, twice daily.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 2.5 Mg Oral Tablet
Other Intervention Name(s)
Xarelto
Intervention Description
Rivaroxaban is an orally administered selective direct factor Xa inhibitor.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Rivaroxaban matched placebo
Primary Outcome Measure Information:
Title
Risk of Major Adverse Cardiac Event (MACE)
Description
To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of; CV death, non-fatal myocardial infarction, stroke, or peripheral artery disease (PAD) events
Time Frame
5 years or trial closure
Secondary Outcome Measure Information:
Title
Composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.
Description
To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.
Time Frame
5 years or trial closure
Title
Composite outcome of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.
Description
To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.
Time Frame
5 years or trial closure
Title
Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.
Description
To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, or stroke.
Time Frame
5 years or trial closure
Title
Incidence of Cardiovascular Death
Description
To determine whether the intervention, compared to placebo, changes the risk of Cardiovascular Death
Time Frame
5 years or trial closure
Title
Incidence of Non-Fatal Myocardial Infarction
Description
To determine whether the intervention, compared to placebo, changes the risk of Non-Fatal Myocardial Infarction
Time Frame
5 years or trial closure
Title
Incidence of Stroke
Description
To determine whether the intervention, compared to placebo, changes the risk of Stroke
Time Frame
5 years or trial closure
Title
Incidence of PAD Events
Description
To determine whether the intervention, compared to placebo, changes the risk of PAD events
Time Frame
5 years or trial closure
Title
Net Clinical Benefit - incidence of MACE & Bleeding
Description
To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, stroke, PAD events, fatal bleeding, or symptomatic bleeding into a critical organ.
Time Frame
5 years or trial closure
Title
Incidence of Venous Thromboembolism
Description
To determine whether the intervention, compared to placebo, changes the risk of Venous Thromboembolism
Time Frame
5 years or trial closure
Other Pre-specified Outcome Measures:
Title
Cost Effectiveness of Intervention - Cost of intervention, & Net benefit in time to MACE event in intervention, when compared to placebo.
Description
To determine whether the intervention, compared to placebo, is cost effective. Where the primary outcome is positive, the cost of providing the intervention will be assessed against the MACE benefit achieved to determine if the treatment meets regulatory guidelines for cost effectiveness. E.g of the Australian Pharmaceutical Benefits Scheme (PBS).
Time Frame
5 years or trial closure
Title
Incidence of Thrombosis of dialysis vascular access
Description
To determine whether the intervention, compared to placebo, changes the risk of thrombosis of dialysis vascular access among participants with an arteriovenous fistula/graft.
Time Frame
5 years or trial closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: People able to provide informed consent who meet all of the following inclusion criteria: Age ≥18 years, 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, Elevated cardiovascular risk, defined by at least one of the following: History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or Diabetes mellitus, or Age ≥65 years. Exclusion Criteria: Potential participants must have none of the following exclusion criteria at the time of study enrolment: Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation), Indication for, or contraindication to, anticoagulant therapy, High bleeding risk including any coagulopathy, Lesion or condition considered to be a significant risk of major bleeding, Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding, 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, Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4, Any stroke within 1 month prior to enrolment, Any previous history of a haemorrhagic or lacunar stroke, Severe heart failure with known ejection fraction <30% or New York Heart Association class III or IV symptoms, History of hypersensitivity or known contraindication to rivaroxaban, Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening Haemoglobin <90 g/L, or platelet count <100 x 109/L, Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) >3 times upper normal limit, Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery, 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, Inability to understand or comply with the requirements of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil Badve
Phone
+61 2 8052 4636
Email
sbadve@georgeinstitute.org.au
First Name & Middle Initial & Last Name or Official Title & Degree
Enmoore Lin
Phone
+61 2 8052 4511
Email
elin@georgeinstitute.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Badve
Organizational Affiliation
The George Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Gallagher
Organizational Affiliation
The George Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Girish Talaulikar
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angus Ritchie
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhadran Bose
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan Smyth
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Yong
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muh Geot Wong
Facility Name
Wollongong Hospital
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Chen
Facility Name
Logan Hospital
City
Meadowbrook
State/Province
Queensland
ZIP/Postal Code
4131
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Frazier
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dakshinamurthy Divi
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpanjali Jesudason
Facility Name
Bendigo Health
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3552
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Ong
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Flavell
Facility Name
Armadale Hospital
City
Armadale
State/Province
Western Australia
ZIP/Postal Code
6112
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hemant Kulkarni
Facility Name
Research St. Joseph's - Hamilton
City
Hamilton
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Walsh
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Sood
Facility Name
Centre Hospitalier Régional Universitaire de Nancy
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54035
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc FRIMAT
Facility Name
Hôpital de Mercy, (CH Metz-Thionville)
City
Ars-Laquenexy
ZIP/Postal Code
57530
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin SAVENKOFF
Facility Name
Hôpital Ambroise Paré, (AP-HP)
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziad MASSY
Facility Name
CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)
City
Boulogne-sur-Mer
ZIP/Postal Code
62200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre BATAILLE
Facility Name
Hôpital de la Cavale Blanche, (CHU Brest)
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yannick LE MEUR
Facility Name
AURAL Colmar, (AURAL Colmar)
City
Colmar
ZIP/Postal Code
68000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire BORNI-DUVAL
Facility Name
AURAL Haguenau, (AURAL Haguenau)
City
Haguenau
ZIP/Postal Code
67500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves DIMITROFF
Facility Name
CH Haguenau, (CH Haguenau)
City
Haguenau
ZIP/Postal Code
67500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves DIMITROFF
Facility Name
ALURAD Buisson, (ALURAD Buisson)
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine ACHARD-HOTTELART
Facility Name
CHU Dupuytren, (CHU Dupuytren)
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel ACHARD
Facility Name
Hôpital Edouard Herriot, (CHU Lyon)
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent JUILLARD
Facility Name
Hôpital de la Conception, (AP-HM)
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane BURTEY
Facility Name
AURAL Mulhouse, (AURAL Mulhouse)
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François CHANTREL
Facility Name
CH Mulhouse, (CH Mulhouse)
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François CHANTREL
Facility Name
Hôpital Pasteur, (CHU Nice)
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent ESNAULT
Facility Name
Hôpital Lyon Sud, (CHU Lyon)
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis FOUQUE
Facility Name
Hôpital de la Maison Blanche, (CHU Reims)
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe RIEU
Facility Name
AURAL Strasbourg, (AURAL Strasbourg)
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry HANNEDOUCHE
Facility Name
Hôpital Bretonneau, (CHRU Tours)
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Michel HALIMI
Facility Name
Hôpitaux de Brbaois, (ALTIR)
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelly CASTIN
Facility Name
All India Institute Of Medical Sciences, Raipur
City
Raipur
State/Province
Chhattisgarh
ZIP/Postal Code
700020
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vinay Rathore
Facility Name
Muljibhai Patel Urological Hospital
City
Nadiād
State/Province
Gujarat
ZIP/Postal Code
387001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umapati N Hegde
Facility Name
Kasturba Medical College and Hospital, Manipal
City
Udupi
State/Province
Karnataka
ZIP/Postal Code
576104
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shankar Prasad Nagaraju
Facility Name
Noble Annex Hospital
City
Hadapsar
State/Province
Pune Maharashtra
ZIP/Postal Code
411013
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avinash Ignatius
Facility Name
All India Institute of Medical Sciences, Bathinda
City
Bathinda
State/Province
Punjab
ZIP/Postal Code
151001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saurabh Nayak
Facility Name
Aykai Super Speciality Hospital, Ludhiana
City
Ludhiāna
State/Province
Punjab
ZIP/Postal Code
141010
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ritika Bansal
Facility Name
Aysha Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600010
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balaraman V
Facility Name
Osmania General Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manisha Sahay
Facility Name
Citizens Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500019
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seerapani Gopaluni
Facility Name
Nizam's Institute of Medical Sciences, Hyderabad
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500082
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sree Bhushan Raju
Facility Name
Postgraduate Institute of Medical Education and Research, Chandigarh
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raja Ramachandran
Facility Name
KG Hospital, K.Govindaswamy Naidu Medical Trust
City
Coimbatore
ZIP/Postal Code
641018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilangovan Veerappan
Facility Name
VS Hospital
City
Kilpauk
ZIP/Postal Code
600010
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suresh Sankar
Facility Name
Institute of Post-Graduate Medical Education and Research
City
Kolkata
ZIP/Postal Code
700020
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dipankar Sircar
Facility Name
Government Hospital
City
Nandyāl
ZIP/Postal Code
518501
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sashidhar Chennamsetty
Facility Name
Government Hospital
City
Proddatūr
ZIP/Postal Code
516362
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sashidhar Chennamsetty
Facility Name
Sooriya Hospital
City
Saligramam
ZIP/Postal Code
600093
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suresh Sankar
Facility Name
L & T Prayas Medical Centre
City
Virugambakkam
ZIP/Postal Code
600092
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suresh Sankar
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Faisal Asmee
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Hasnul Halimi Wan Hassan
Facility Name
Hospital Tuanku Ja'afar, Seremban
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lily Mushahar
Facility Name
Hospital Seberang Jaya
City
Seberang Jaya
State/Province
Penang
ZIP/Postal Code
13700
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Bhajan Manocha
Facility Name
Hospital Raja Permaisuri Bainun, Ipoh
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sridhar Ramanaidu
Facility Name
Hospital Queen Elizabeth, Kota Kinabalu
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88200
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan Fei Sia
Facility Name
Hospital Kajang
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadanah Aqashiah Mazlan
Facility Name
Hospital Canselor Tuanku Muhriz
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halim Gafor
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Kum Lim
Facility Name
Hemodialysis Care Project North Centre
City
Al-Yasmin
State/Province
Riyadh
ZIP/Postal Code
13322
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdi H Alla
Facility Name
Hemodialysis King Abdullah Centre
City
Al-Yasmin
State/Province
Riyadh
ZIP/Postal Code
13322
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noon Mohammed
Facility Name
ialysis Centre - King Abdul Aziz Medical City (KAMC)
City
Ar-Rimayah
State/Province
Riyadh
ZIP/Postal Code
11481
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Tawhari
Facility Name
Hemodialysis Care Project South Centre
City
Riyad
State/Province
Riyadh
ZIP/Postal Code
12799-6176
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salah Abdelwahab
Facility Name
King Abdullah International Medical Research Center
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Altawhari
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weng Wanting
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
767828
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Ling Grace Tan
Facility Name
Fu-Jen Catholic University Hospital
City
Taishan
State/Province
New Taipei City
ZIP/Postal Code
243
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yee-Yung Ng
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Wen Chiu
Facility Name
Kaohsiung Chang-Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Bor Chen
Facility Name
Chung-Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horng-Rong Chang
Facility Name
Wan fang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuh-Mou Sue
Facility Name
Taipei Tzu Chi Hospital
City
Taipei
ZIP/Postal Code
231
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Szu-Chun Hung
Facility Name
Chang Gung Memorial Hospital, Linkou Medical Center
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Hao Weng
Facility Name
Fattouma Bourguiba Hospital
City
Monastir
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Habib Skhir
Facility Name
Hedi chaker Hospital
City
Sfax
Country
Tunisia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed ben Hmida
Facility Name
Sahloul Hospital
City
Sousse
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorsaf Zellama
Facility Name
Charles Nicolle Hospital
City
Tunis
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fethi Ben Hamida
Facility Name
La Rabta Hospital
City
Tunis
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Zouaghi
Facility Name
Military Hospital
City
Tunis
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jannet Labidi
Facility Name
Mongi Slim Hospital
City
Tunis
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rim Goucha

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
To be confirmed
IPD Sharing Access Criteria
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.
Links:
URL
http://www.tracktrial.org
Description
Trial Website

Learn more about this trial

Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

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