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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03862859
Other study ID # DANWARD 1.26
Secondary ID 2018-000484-86
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 9, 2019
Est. completion date January 2027

Study information

Verified date February 2024
Source Rigshospitalet, Denmark
Contact Nicholas Carlson, MD PhD
Phone +45 35455827
Email nicholas.carlson.01@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and atrial fibrillation.


Description:

Data pertaining to the tolerability, safety, and benefit of initiating anticoagulation for stroke risk reduction in patients with end-stage renal disease and atrial fibrillation remains conflicting and insufficient. Patients on dialysis continue to be routinely excluded from randomized controlled trials, and evidence from observational studies is plausibly biased. The main objective of the following parallel-group open randomized clinical trial presents a nationwide study aimed at investigating the benefit, tolerability, and safety of initiating warfarin versus no treatment in patients with atrial fibrillation on dialysis. The anticipated results from this project will provide conclusive evidence as to the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation with direct effects on clinical management and international guidelines pertaining to these patients. The study is planned as a multicentre, randomized, open label, parallel group trial with planned inclusion of a total of 718 patients (359 patients per arm). Dialysis-treated patients with end-stage renal disease with paroxysmal, persistent, or permanent atrial fibrillation will be enrolled and randomized to either treatment with warfarin or no treatment. Randomization with be attained using a 1:1 allocation as per a computer-generated randomization schedule stratified by gender, age by decade, and center using permuted blocks of random sizes. Study participants will be allocated to treatment in accordance with the randomization for the full duration of the trial i.e. at a minimum one year following randomization, and followed with regular monitoring for the the primary efficacy outcome of ischemic stroke or death due to ischemic or unspecified stroke and the primary safety outcome of major bleeding defined in accordance with the International Society on Thrombosis and Hemostasis definition.


Recruitment information / eligibility

Status Recruiting
Enrollment 718
Est. completion date January 2027
Est. primary completion date January 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients =18 years on chronic dialysis due to end-stage renal disease - Non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for >2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of =30 seconds on Holter monitor, or episodes = 6 minutes on event recorders or any other recording device. - Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent. Exclusion Criteria: - CHA2DS2-VASc Score =1 - Other indications for oral anticoagulation treatment (pulmonary embolism < 6 months, deep vein thrombosis <3 months, mechanical heart valve prosthesis) irrespective of whether treatment is implemented - Ongoing dual antiplatelet treatment - Malignancy (with exception of non-melanoma skin cancer) with recent < 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and/or scheduled surgical therapy - Endoscopy with gastrointestinal ulcer <1 month - Esophageal varices - Autoimmune og genetic coagulation disorders - Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption - Pending spinal tap - Cerebrovascular malformations - Arterial aneurysms - Ulcers or wounds (Wagner grad >1) - Bacterial endocarditis < 3 months - Active bleeding contraindicating anticoagulation - Any non-elective and/or non-ambulant surgery <7 days - Cerebral hemorrhage <4 weeks - Thrombocytopenia (platelet count <100 × 109/L) <30 days. - Severe liver insufficiency (spontaneous international normalized ratio >1.5) <30 days. - Known intolerance to warfarin - Use of hypericum perforatum / St. John's Wort - Uncontrolled hypertension (repeat blood pressure >180/110 mmhg) < 30 days - Uncontrolled hyperthyroidism (thyroid-stimulating hormone <0.1µIU/mL) <30 days - Pregnancy or lactation - Participation in other ongoing intervention trials adjudged to influence study outcomes

Study Design


Intervention

Drug:
Warfarin
Dose adjusted Warfarin targeting an international normalized ratio of 2-3.

Locations

Country Name City State
Denmark Aalborg University Hosptial Aalborg
Denmark Aarhus University Hospital Aarhus
Denmark Department of Nephrology, Copenhagen University Hospital Rigshospitalet Copenhagen
Denmark Esbjerg and Grindsted Hospital Esbjerg
Denmark Department of Nephrology, Herlev Hospital Herlev
Denmark Department of nephrology, Nordsjaellands Hospital Hillerød
Denmark Holbaek Hospital Holbæk
Denmark Holstebro Hospital Holstebro
Denmark Lillebælt Hospital Kolding
Denmark Bornholms Hospital Rønne
Denmark Zealand University Hospital Roskilde
Denmark Hospital Sønderjylland Sønderborg
Denmark Viborg Regional Hospital Viborg

Sponsors (2)

Lead Sponsor Collaborator
Nicholas Carlson Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
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
Other 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
Other 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
Other 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
Other 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
Other 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
Other 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
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 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
Secondary 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
Secondary 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
Secondary 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
Secondary Number of deaths All-cause mortality From time of randomization to end of observation - up to 4 years
Secondary 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
Secondary 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
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