Clinical Trial Details
| Trial ID: | L1696 |
| Source ID: | NCT03987711 |
| Associated Drug: | Warfarin |
| Title: | Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis |
| Acronym: | SAFE-D |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Atrial Fibrillation|End Stage Renal Failure on Dialysis |
| Interventions: | DRUG: Warfarin|DRUG: Apixaban|OTHER: No oral anticoagulation |
| Outcome Measures: | Primary: Recruitment of the target population within 2 years, 2 years from start of trial|At least 80% of randomized participants remain in the trial and on the allocated study treatment at the end of the 26-week study period., 26 weeks | Secondary: Proportion of patients randomized to warfarin achieving a Time in the Therapeutic Range (TTR) >65%., 26 weeks|>95% of randomized patients adhere to the enrollment criteria with respect to atrial fibrillation or atrial flutter, Through adjudication of ECGs or other cardiac diagnostics, End of trial|Major bleeding, As defined by the International Society of Thrombosis and Haemostasis (ISTH), 26 weeks|Clinically relevant non-major bleeding, As defined by the International Society of Thrombosis and Haemostasis (ISTH), 26 weeks|Stroke and systemic embolism, 26 weeks|All cause mortality, 26 weeks|Non-fatal myocardial infarction, 26 weeks|Vascular events not related to dialysis access, 26 weeks|Events of special interest related to dialysis access, the dialysis procedure or the oral anticoagulants, Thrombosis of fistula or graft; fistula or graft abandonment; thrombosis of dialysis catheter; red blood cell transfusions; calciphylaxis, 26 weeks |
| Sponsor/Collaborators: | Sponsor: Unity Health Toronto | Collaborators: Canadian Institutes of Health Research (CIHR)|The George Institute for Global Health (Sydney, Australia) |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 151 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2019-12-10 |
| Completion Date: | 2022-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2023-06-22 |
| Locations: | Nepean Hospital, Kingswood, New South Wales, 2747, Australia|Prince of Wales Hospital, Randwick, New South Wales, 2031, Australia|Royal North Shore Hospital, Saint Leonards, New South Wales, 2065, Australia|St. George Hospital, Sydney, Australia|Surrey Memorial Hospital, Surrey, British Columbia, V3V 0C6, Canada|St. Paul's Hospital, Vancouver, British Columbia, V6Z 1Y6, Canada|Seven Oaks General Hospital, Winnipeg, Manitoba, R2V 3M3, Canada|Nova Scotia Health Authority, QEII Health Sciences Centre, Halifax, Nova Scotia, B3H 1V7, Canada|Royal Victoria Regional Health Centre, Barrie, Ontario, L4M 6M2, Canada|St. Joseph's Healthcare Hamilton, Hamilton, Ontario, L8N 4A6, Canada|Kingston Health Sciences Centre - Kingston General Hospital, Kingston, Ontario, K7L 2V7, Canada|London Health Sciences Centre, London, Ontario, N6A 5A5, Canada|Halton Healthcare - Oakville Trafalgar Memorial Hospital, Oakville, Ontario, L6M 0L8, Canada|Lakeridge Health Oshawa, Oshawa, Ontario, L1G 2B9, Canada|The Ottawa Hospital - Riverside Campus, Ottawa, Ontario, Canada|Health Sciences North, Sudbury, Ontario, P3E 5J1, Canada|Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, P7B 6V4, Canada|Sunnybrook Health Sciences Centre, Toronto, Ontario, M4G 3E8, Canada|Unity Health Toronto, at its St. Michael's Hospital site, Toronto, Ontario, M5B 1W8, Canada|University Health Network - Toronto General Hospital, Toronto, Ontario, M6K3S2, Canada|St. Joseph's Health Centre Toronto, Toronto, Ontario, M6R 1B5, Canada|McGill University Health Centre, Montreal, Quebec, H8S 4K4, Canada|Hôpital Maisonneuve-Rosemont, Montréal, Quebec, H1T 2M4, Canada|Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, H2X 3E4, Canada|Jewish General Hospital, Montréal, Quebec, H3T 1E2, Canada|Hôpital du Sacré-Cœur de Montréal, Montréal, Quebec, H4J 1C5, Canada|CHU de Québec - Université Laval, Quebec City, Quebec, G1R 2J6, Canada|Regina General Hospital, Regina, Saskatchewan, S4P 0W5, Canada |
| URL: | https://clinicaltrials.gov/show/NCT03987711 |
