| Trial ID: | L1602 |
| Source ID: | NCT03862859
|
| Associated Drug: |
Warfarin
|
| Title: |
The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
|
| Acronym: |
DANWARD
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Atrial Fibrillation and Flutter|Stroke|Major Bleed|End-stage Renal Disease
|
| Interventions: |
DRUG: Warfarin
|
| Outcome Measures: |
Primary: Primary efficacy outcome - Number of participants with transient ischemic attack, fatal and non-fatal ischaemic or unspecific stroke, Any transient ischemic attack, fatal and non-fatal ischaemic or unspecific stroke or death attributable to either ischemic or undefined stroke, From randomization to end of observation - up to 4 years|Primary safety outcome - Number of participants with fatal or non-fatal major bleeding, Any major bleeding as defined in accordance with the International Society on Thrombosis and Hemostasis definition pertaining to major bleeding in non-surgical patients, From randomization to end of observation - up to 4 years | Secondary: Number of participants with ischemic or unspecified stroke, Any non-fatal or fatal ischemic stroke or unspecified stroke event, From time of randomization to end of observation - up to 4 years|Number of participants with ischemic stroke, Any non-fatal or fatal ischemic stroke event, From time of randomization to end of observation - up to 4 years|Number of participants with hemorrhagic stroke, Any non-fatal or fatal hemorrhagic stroke event, From time of randomization to end of observation - up to 4 years|Number of participants with ischemic or hemorrhagic stroke, Any non-fatal or fatal ischemic or hemorrhagic stroke event, From time of randomization to end of observation - up to 4 years|Number of deaths, All-cause mortality, From time of randomization to end of observation - up to 4 years|The combination of any non-fatal stroke and all-cause mortality, Number of participants with either non-fatal ischemic or hemorrhagic stroke of death due to any cause, From time of randomization to end of observation - up to 4 years|The combination of any non-fatal stroke, any non-fatal major bleeding, and all-cause mortality, Number of participants with either non-fatal ischemic or hemorrhagic stroke, any non-fatal major bleeding as defined in accordance with the International Society on Thrombosis and Hemostasis definition pertaining to major bleeding in non-surgical patients, or death due to any cause, From time of randomization to end of observation - up to 4 years | Other: Discontinuation of the allocated randomized therapy, Number of participants discontinuing the allocated randomized therapy irrespective of cause, From time of randomization to end of observation - up to 4 years|Number of participants with peripheral artery disease, Any diagnosis of previously unverified peripheral artery disease, From time of randomization to end of observation - up to 4 years|Number of participants with fatal or non-fatal acute myocardial infarction, Any non-fatal or fatal acute myocardial infarction event, From randomization to end of observation - up to 4 years|Number of participants with calciphylaxis, Development of calciphylaxis as defined by clinical diagnosis, From time of randomization to end of observation - up to 4 years|Number of participants hospitalized due to left-sided heart failure, Any hospitalization due to left-sided heart failure as defined by de novo LVEF \<30% with echocardiographic verification, From time of randomization to end of observation - up to 4 years|Percentage of participants with arteriovenous fistula thrombosis, Arteriovenous fistula thrombosis in participants dialyzed via an arteriovenous fistula, From randomization to end of observation - up to 4 years|Number of participants with osteoporotic fractures, Osteoporotic fractures as defined by low energy fractures of the proximal femur, distal radius, humerus, pelvis, and vertebrae, From randomization to end of observation - up to 4 years
|
| Sponsor/Collaborators: |
Sponsor: Nicholas Carlson | Collaborators: Danish Heart Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
718
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2019-10-09
|
| Completion Date: |
2027-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-26
|
| Locations: |
Aalborg University Hosptial, Aalborg, 9100, Denmark|Aarhus University Hospital, Aarhus, 8200, Denmark|Department of Nephrology, Copenhagen University Hospital Rigshospitalet, Copenhagen, 2100, Denmark|Esbjerg and Grindsted Hospital, Esbjerg, 6700, Denmark|Department of Nephrology, Herlev Hospital, Herlev, 2730, Denmark|Department of nephrology, Nordsjaellands Hospital, Hillerød, 3400, Denmark|Holbaek Hospital, Holbæk, 4300, Denmark|Holstebro Hospital, Holstebro, 7500, Denmark|Lillebælt Hospital, Kolding, Denmark|Zealand University Hospital, Roskilde, 4000, Denmark|Bornholms Hospital, Rønne, 3700, Denmark|Hospital Sønderjylland, Sønderborg, 6400, Denmark|Viborg Regional Hospital, Viborg, 8800, Denmark
|
| URL: |
https://clinicaltrials.gov/show/NCT03862859
|
