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Clinical Trial Details

Trial ID: L0482
Source ID: NCT03969953
Associated Drug: Rivaroxaban 2.5 Mg Oral Tablet
Title: Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Acronym: TRACK
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Diseases|Dialysis-dependent Kidney Failure|Cardiovascular Disease
Interventions: DRUG: Rivaroxaban 2.5 Mg Oral Tablet|OTHER: Placebo
Outcome Measures: Primary: 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, 5 years or trial closure | Secondary: 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., 5 years or trial closure|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., 5 years or trial closure|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., 5 years or trial closure|Incidence of Cardiovascular Death, To determine whether the intervention, compared to placebo, changes the risk of Cardiovascular Death, 5 years or trial closure|Incidence of Non-Fatal Myocardial Infarction, To determine whether the intervention, compared to placebo, changes the risk of Non-Fatal Myocardial Infarction, 5 years or trial closure|Incidence of Stroke, To determine whether the intervention, compared to placebo, changes the risk of Stroke, 5 years or trial closure|Incidence of PAD Events, To determine whether the intervention, compared to placebo, changes the risk of PAD events, 5 years or trial closure|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., 5 years or trial closure|Incidence of Venous Thromboembolism, To determine whether the intervention, compared to placebo, changes the risk of Venous Thromboembolism, 5 years or trial closure | Other: Cost Effectiveness of Intervention - Cost of intervention, & Net benefit in time to MACE event in intervention, when compared to placebo., 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)., 5 years or trial closure|Incidence of Thrombosis of dialysis vascular access, To determine whether the intervention, compared to placebo, changes the risk of thrombosis of dialysis vascular access among participants with an arteriovenous fistula/graft., 5 years or trial closure
Sponsor/Collaborators: Sponsor: The George Institute | Collaborators: George Clinical Pty Ltd|Bayer|Central Hospital, Nancy, France|King Abdullah International Medical Research Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 2000
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-12-14
Completion Date: 2027-12-31
Results First Posted:
Last Update Posted: 2023-11-28
Locations: Canberra Hospital, Garran, Australian Capital Territory, 2605, Australia|Concord Repatriation General Hospital, Concord, New South Wales, 2139, Australia|Nepean Hospital, Kingswood, New South Wales, 2747, Australia|St George Hospital, Kogarah, New South Wales, 2217, Australia|Prince of Wales Hospital, Randwick, New South Wales, 2031, Australia|Royal North Shore Hospital, St Leonards, New South Wales, 2065, Australia|Wollongong Hospital, Wollongong, New South Wales, 2500, Australia|Logan Hospital, Meadowbrook, Queensland, 4131, Australia|Gold Coast University Hospital, Southport, Queensland, 4215, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|Bendigo Health, Bendigo, Victoria, 3552, Australia|Sunshine Hospital, St Albans, Victoria, 3021, Australia|Armadale Hospital, Armadale, Western Australia, 6112, Australia|Research St. Joseph's - Hamilton, Hamilton, Canada|Ottawa Hospital Research Institute, Ottawa, Canada|Centre Hospitalier Régional Universitaire de Nancy, Nancy, Meurthe-et-Moselle, 54035, France|Hôpital de Mercy, (CH Metz-Thionville), Ars-Laquenexy, 57530, France|Hôpital Ambroise Paré, (AP-HP), Boulogne-Billancourt, 92100, France|CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer), Boulogne-sur-Mer, 62200, France|Hôpital de la Cavale Blanche, (CHU Brest), Brest, 29200, France|AURAL Colmar, (AURAL Colmar), Colmar, 68000, France|AURAL Haguenau, (AURAL Haguenau), Haguenau, 67500, France|CH Haguenau, (CH Haguenau), Haguenau, 67500, France|ALURAD Buisson, (ALURAD Buisson), Limoges, 87000, France|CHU Dupuytren, (CHU Dupuytren), Limoges, 87000, France|Hôpital Edouard Herriot, (CHU Lyon), Lyon, 69003, France|Hôpital de la Conception, (AP-HM), Marseille, 13005, France|AURAL Mulhouse, (AURAL Mulhouse), Mulhouse, 68100, France|CH Mulhouse, (CH Mulhouse), Mulhouse, 68100, France|Hôpital Pasteur, (CHU Nice), Nice, 06000, France|Hôpital Lyon Sud, (CHU Lyon), Pierre-Bénite, 69310, France|Hôpital de la Maison Blanche, (CHU Reims), Reims, 51092, France|AURAL Strasbourg, (AURAL Strasbourg), Strasbourg, 67000, France|Hôpital Bretonneau, (CHRU Tours), Tours, 37000, France|Hôpitaux de Brbaois, (ALTIR), Vandœuvre-lès-Nancy, 54500, France|All India Institute Of Medical Sciences, Raipur, Raipur, Chhattisgarh, 700020, India|Muljibhai Patel Urological Hospital, Nadiād, Gujarat, 387001, India|Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka, 576104, India|Noble Annex Hospital, Hadapsar, Pune Maharashtra, 411013, India|All India Institute of Medical Sciences, Bathinda, Bathinda, Punjab, 151001, India|Aykai Super Speciality Hospital, Ludhiana, Ludhiāna, Punjab, 141010, India|Aysha Hospital, Chennai, Tamil Nadu, 600010, India|Osmania General Hospital, Hyderabad, Telangana, 500012, India|Citizens Hospital, Hyderabad, Telangana, 500019, India|Nizam's Institute of Medical Sciences, Hyderabad, Hyderabad, Telangana, 500082, India|Postgraduate Institute of Medical Education and Research, Chandigarh, Chandigarh, 160012, India|KG Hospital, K.Govindaswamy Naidu Medical Trust, Coimbatore, 641018, India|VS Hospital, Kilpauk, 600010, India|Institute of Post-Graduate Medical Education and Research, Kolkata, 700020, India|Government Hospital, Nandyāl, 518501, India|Government Hospital, Proddatūr, 516362, India|Sooriya Hospital, Saligramam, 600093, India|L & T Prayas Medical Centre, Virugambakkam, 600092, India|Hospital Sultanah Bahiyah, Alor Setar, Kedah, 05460, Malaysia|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, 15586, Malaysia|Hospital Tuanku Ja'afar, Seremban, Seremban, Negeri Sembilan, 70300, Malaysia|Hospital Seberang Jaya, Seberang Jaya, Penang, 13700, Malaysia|Hospital Raja Permaisuri Bainun, Ipoh, Ipoh, Perak, 30450, Malaysia|Hospital Queen Elizabeth, Kota Kinabalu, Kota Kinabalu, Sabah, 88200, Malaysia|Hospital Kajang, Kajang, Selangor, 43000, Malaysia|Hospital Canselor Tuanku Muhriz, Kuala Lumpur, Wilayah Persekutuan, 56000, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan, 59100, Malaysia|Hemodialysis Care Project North Centre, Al-Yasmin, Riyadh, 13322, Saudi Arabia|Hemodialysis King Abdullah Centre, Al-Yasmin, Riyadh, 13322, Saudi Arabia|ialysis Centre - King Abdul Aziz Medical City (KAMC), Ar-Rimayah, Riyadh, 11481, Saudi Arabia|Hemodialysis Care Project South Centre, Riyad, Riyadh, 12799-6176, Saudi Arabia|King Abdullah International Medical Research Center, Riyadh, Saudi Arabia|Tan Tock Seng Hospital, Singapore, 308433, Singapore|Khoo Teck Puat Hospital, Singapore, 767828, Singapore|Fu-Jen Catholic University Hospital, Taishan, New Taipei City, 243, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, 807, Taiwan|Kaohsiung Chang-Gung Memorial Hospital, Kaohsiung, 833, Taiwan|Chung-Shan Medical University Hospital, Taichung, 402, Taiwan|Wan fang Hospital, Taipei, 116, Taiwan|Taipei Tzu Chi Hospital, Taipei, 231, Taiwan|Chang Gung Memorial Hospital, Linkou Medical Center, Taoyuan, 333, Taiwan|Fattouma Bourguiba Hospital, Monastir, Tunisia|Hedi chaker Hospital, Sfax, Tunisia|Sahloul Hospital, Sousse, Tunisia|Charles Nicolle Hospital, Tunis, Tunisia|La Rabta Hospital, Tunis, Tunisia|Military Hospital, Tunis, Tunisia|Mongi Slim Hospital, Tunis, Tunisia
URL: https://clinicaltrials.gov/show/NCT03969953