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Oral Anticoagulation in Haemodialysis Patients (AVKDIAL)

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ClinicalTrials.gov Identifier: NCT02886962
Recruitment Status : Recruiting
First Posted : September 1, 2016
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE August 29, 2016
First Posted Date  ICMJE September 1, 2016
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE July 12, 2017
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2016)
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02886962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Anticoagulation in Haemodialysis Patients
Official Title  ICMJE Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
Brief Summary

Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.

The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Failure, Chronic
Intervention  ICMJE
  • Biological: No oral anticoagulation
    No oral anticoagulation, and no monitoring of the INR.
  • Drug: Oral anticoagulation with vitamin K antagonists

    Vitamin K antagonist prescription with INR target between 2 and 3 as recommended in the guidelines.

    Administration once daily or at the end of each dialysis session, according to the nephrologist choice.

    INR monitoring at least once per week

Study Arms  ICMJE
  • Experimental: No anticoagulation
    No oral anticoagulation, and no monitoring of the INR.
    Intervention: Biological: No oral anticoagulation
  • Active Comparator: Oral anticoagulation with vitamin K antagonists

    VKA use as recommended in the guidelines with INR target range between 2 and 3. Daily administration or thrice weekly at the end of dialysis sessions upon Nephrologist's choice.

    Antiplatelet therapy will be provided only if recent acute coronary syndrome (< 6 months) or active coronary stent. Aspirin should be preferred in dialysis patients as clopidogrel has an unpredictable reduced activity and there is no safety data on combination of VKA with prasugrel or ticagrelor in this population.

    Intervention: Drug: Oral anticoagulation with vitamin K antagonists
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 29, 2016)
855
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (≥ 18 years)
  • Patient on hemodialysis treatment for at least 1 month
  • Patient with a history of, or presenting a new episode of atrial fibrillation (either permanent or paroxysmal).
  • Patient with a CHADS2VASC score ≥2
  • Patient with high risk of bleeding as defined by (1) HASBLED score ≥3 OR (2) HASBLED ≥ CHADS2VASC score, OR (3) recent history of severe bleeding (type 3a, 3b, 3c), particularly cerebral or gastrointestinal, OR (4) prior recurrent (>2) history of falls.
  • Patient capable of understanding information about the study and of giving his/her consent
  • Patient informed of the preliminary medical exam results
  • Patient with healthcare insurance
  • Written consent signed

Exclusion Criteria:

  • Formal indication to oral anticoagulation beside atrial fibrillation (mechanic heart valves, recurrent thrombophlebitis, antiphospholipid syndrome)
  • Life expectancy < 6 months (e.g., terminal cancer)
  • Live donor transplantation scheduled within 6 months
  • Pregnancy (β-HCG blood-based assay)or nursing (lactating) women
  • Women of child bearing potential, unless they are using an effective method of birth control
  • Patient under legal guardianship
  • Patients under law protection
  • Known hypersensibility to coumadin or indoine derivatives or to any excipients (CI to oral AVK)
  • Severe liver failure (CI to oral AVK)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thierry Hannedouche, MD 0388116768 thierry.hannedouche@chru-strasbourg.fr
Contact: Thierry Krummel, MD 0388116768 thierry.krummel@chru-strasbourg.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02886962
Other Study ID Numbers  ICMJE 6396
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Strasbourg, France
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP