Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Who is this study for? Patients with End Stage Renal Disease
What treatments are being studied? Rivaroxaban
Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Bendigo Health
RECRUITING
Bendigo
Concord Repatriation General Hospital
RECRUITING
Concord
Canberra Hospital
RECRUITING
Garran
Nepean Hospital
ACTIVE_NOT_RECRUITING
Kingswood
St George Hospital
RECRUITING
Kogarah
Logan Hospital
RECRUITING
Meadowbrook
Prince of Wales Hospital
RECRUITING
Randwick
Sunshine Hospital
RECRUITING
St Albans
Royal North Shore Hospital
ACTIVE_NOT_RECRUITING
St Leonards
Wollongong Hospital
RECRUITING
Wollongong
Belgium
AZ Sint-Jan Brugge
ACTIVE_NOT_RECRUITING
Bruges
Canada
University of Alberta
ACTIVE_NOT_RECRUITING
Edmonton
Research St. Joseph's - Hamilton
ACTIVE_NOT_RECRUITING
Hamilton
France
CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)
RECRUITING
Boulogne-sur-mer
Hôpital de la Cavale Blanche, (CHU Brest)
RECRUITING
Brest
AURAL Colmar, (AURAL Colmar)
RECRUITING
Colmar
Hopital Louis Pasteur (CH Colmar)
RECRUITING
Colmar
AURAL Haguenau, (AURAL Haguenau)
RECRUITING
Haguenau
CH Haguenau, (CH Haguenau)
RECRUITING
Haguenau
CH Le Puy-en-Velay
RECRUITING
Le Puy-en-velay
Hôpital Edouard Herriot, (CHU Lyon)
RECRUITING
Lyon
Hôpital de la Conception, (AP-HM)
RECRUITING
Marseille
AURAL Mulhouse, (AURAL Mulhouse)
RECRUITING
Mulhouse
CH Mulhouse, (CH Mulhouse)
RECRUITING
Mulhouse
Centre Hospitalier Régional Universitaire de Nancy
RECRUITING
Nancy
Hôpital Pasteur, (CHU Nice)
RECRUITING
Nice
Hôpital de la Maison Blanche, (CHU Reims)
RECRUITING
Reims
AURAL Strasbourg, (AURAL Strasbourg)
RECRUITING
Strasbourg
Hôpital Bretonneau, (CHRU Tours)
RECRUITING
Tours
Hôpitaux de Brbaois, (ALTIR)
RECRUITING
Vandœuvre-lès-nancy
Germany
KRH Klinikum Siloah
RECRUITING
Hanover
India
All India Institute of Medical Sciences, Bathinda
ACTIVE_NOT_RECRUITING
Bathinda
AIIMS Bhubaneswar
RECRUITING
Bhubaneswar
Postgraduate Institute of Medical Education and Research, Chandigarh
RECRUITING
Chandigarh
Apollo Hospital
ACTIVE_NOT_RECRUITING
Chennai
Aysha Hospital
ACTIVE_NOT_RECRUITING
Chennai
KG Hospital, K.Govindaswamy Naidu Medical Trust
ACTIVE_NOT_RECRUITING
Coimbatore
Noble Annex Hospital
ACTIVE_NOT_RECRUITING
Hadapsar
Asian Institute of Nephrology and Urology
ACTIVE_NOT_RECRUITING
Hyderabad
Citizens Hospital
ACTIVE_NOT_RECRUITING
Hyderabad
Nizam's Institute of Medical Sciences, Hyderabad
RECRUITING
Hyderabad
Osmania General Hospital
RECRUITING
Hyderabad
VS Hospital
ACTIVE_NOT_RECRUITING
Kilpauk
Institute of Post-Graduate Medical Education and Research
ACTIVE_NOT_RECRUITING
Kolkata
Nil Ratan Sircar Medical College and Hospital
ACTIVE_NOT_RECRUITING
Kolkata
Aykai Super Speciality Hospital, Ludhiana
ACTIVE_NOT_RECRUITING
Ludhiana
Nutema Hospital
ACTIVE_NOT_RECRUITING
Meerut
Muljibhai Patel Urological Hospital
ACTIVE_NOT_RECRUITING
Nadiād
Government Hospital
RECRUITING
Nandyāl
Safdarjung Hospital
ACTIVE_NOT_RECRUITING
New Delhi
Government Hospital
ACTIVE_NOT_RECRUITING
Proddatūr
All India Institute Of Medical Sciences, Raipur
RECRUITING
Raipur
Sooriya Hospital
WITHDRAWN
Saligramam
Kasturba Medical College and Hospital, Manipal
WITHDRAWN
Udupi
L & T Prayas Medical Centre
WITHDRAWN
Virugambakkam
Malaysia
Hospital Sultanah Bahiyah
ACTIVE_NOT_RECRUITING
Alor Star
Hospital Ampang
ACTIVE_NOT_RECRUITING
Ampang
Hospital Raja Permaisuri Bainun, Ipoh
ACTIVE_NOT_RECRUITING
Ipoh
Hospital Kajang
ACTIVE_NOT_RECRUITING
Kajang
Hospital Raja Perempuan Zainab II
RECRUITING
Kota Bharu
Hospital Queen Elizabeth, Kota Kinabalu
ACTIVE_NOT_RECRUITING
Kota Kinabalu
Hospital Canselor Tuanku Muhriz
ACTIVE_NOT_RECRUITING
Kuala Lumpur
University of Malaya Medical Centre
ACTIVE_NOT_RECRUITING
Kuala Lumpur
Hospital Pakar Sultanah Fatimah Muar
ACTIVE_NOT_RECRUITING
Muar Town
Hospital Seberang Jaya
ACTIVE_NOT_RECRUITING
Seberang Jaya
Hospital Tuanku Ja'afar, Seremban
ACTIVE_NOT_RECRUITING
Seremban
Nepal
Tribhuvan University College
RECRUITING
Kathmandu
Saudi Arabia
Hemodialysis Care Project North Centre
ACTIVE_NOT_RECRUITING
Al Yāsamīn
Hemodialysis King Abdullah Centre
ACTIVE_NOT_RECRUITING
Al Yāsamīn
Dialysis Centre - King Abdul Aziz Medical City (KAMC)
ACTIVE_NOT_RECRUITING
Ar Rimāyah
King Abdulaziz Medical City - Western Region - Jeddah, Ministry of National Guard - Health Affairs
ACTIVE_NOT_RECRUITING
Jeddah
Hemodialysis Care Project South Centre
ACTIVE_NOT_RECRUITING
Riyadh
King Saud University Medical City (KSUMC)
ACTIVE_NOT_RECRUITING
Riyadh
Singapore
Khoo Teck Puat Hospital
ACTIVE_NOT_RECRUITING
Singapore
Tan Tock Seng Hospital
ACTIVE_NOT_RECRUITING
Singapore
Taiwan
Kaohsiung Chang-Gung Memorial Hospital
COMPLETED
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
COMPLETED
Kaohsiung City
Chung-Shan Medical University Hospital
COMPLETED
Taichung
Taipei Tzu Chi Hospital
COMPLETED
Taipei
Wan fang Hospital
COMPLETED
Taipei
Fu-Jen Catholic University Hospital
ACTIVE_NOT_RECRUITING
Taishan
Chang Gung Memorial Hospital, Linkou Medical Center
COMPLETED
Taoyuan District
Tunisia
Fattouma Bourguiba Hospital
ACTIVE_NOT_RECRUITING
Monastir
Hedi chaker Hospital
ACTIVE_NOT_RECRUITING
Sfax
Sahloul Hospital
ACTIVE_NOT_RECRUITING
Sousse
Charles Nicolle Hospital
ACTIVE_NOT_RECRUITING
Tunis
La Rabta Hospital
ACTIVE_NOT_RECRUITING
Tunis
Military Hospital
ACTIVE_NOT_RECRUITING
Tunis
Mongi Slim Hospital
ACTIVE_NOT_RECRUITING
Tunis
Taher Sfar Hospital
ACTIVE_NOT_RECRUITING
Tunis
Contact Information
Primary
Sunil Badve
sbadve@georgeinstitute.org.au
+61 2 8052 4636
Backup
Jenny Landrigan
jlandrigan@georgeinstitute.org.au
+61 2 8052 4511
Time Frame
Start Date: 2020-12-14
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 2000
Treatments
Experimental: Rivaroxaban
Rivaroxaban 2.5mg, twice daily.
Placebo_comparator: Placebo
Matched placebo, twice daily.
Related Therapeutic Areas
Sponsors
Collaborators: Bayer, King Abdullah International Medical Research Center, Central Hospital, Nancy, France, Emerald Clinical Inc.
Leads: The George Institute