Kidney Failure, ChronicPhase 4AVKDIALNCT02886962
Oral Anticoagulation in Haemodialysis Patients
A Phase 4 study testing No oral anticoagulation and Oral anticoagulation with vitamin K antagonists in people with Kidney Failure, Chronic, run by University Hospital, Strasbourg, France at 25 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- No oral anticoagulation and Oral anticoagulation with vitamin K antagonists
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 25 sitesFrance
- Study dates
- 12 Jul 2017to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patient informed of the preliminary medical exam results
- Patient with healthcare insurance
- Written consent signed
Who cannot join
- 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
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- 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)
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Service de Néphrologie et médecine interne
Amiens, 80000
CHRU d'Angers - Service de Néphrologie
Angers, 49033
Service Néphrologie, Dialyse, Transplantation
Caen, 14033
Pathologie Rénale
Chambéry, 73000
Service de Néphrologie
Cherbourg-Octeville, 50102
Aural Colmar
Colmar, 68000
Service de néphrologie
Colmar, 68000
Service de néphrologie
Dijon, 21000
Aurad Aquitaine
Gradignan, 33170
Centre Hospitalier de Haguenau - service de Néphrologie
Haguenau, 67504
AURAL Haguenau
Haguenau
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43000
Clinique Bouchard
Marseille, 13006
Service de Néphrologie
Nancy, 54511
ECHO de Nantes
Nantes, 44000
Service de Néphrologie
Nantes, 44093
AURA Paris Plaisance
Paris, 75014
Hôpital Tenon - Service de Néphrologie
Paris, 75970
Service de néphrologie
Rennes, 35033
ECHO CA Laennec
Saint-Herblain, 44821
NéphroCare Tassin-Charcot
Sainte-Foy-lès-Lyon, 69110
AURAL st Anne
Strasbourg, 67000
Service de Néphrologie
Strasbourg, 67000
Centre Hospitalier Bretagne-Atlantique
Vannes, 56017
Calydial CH Lucien Hussel
Vienne, 38209
About this study
Official title: Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- No oral anticoagulation, Oral anticoagulation with vitamin K antagonists
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No oral anticoagulationBiological
No oral anticoagulation, and no monitoring of the INR.
Oral anticoagulation with vitamin K antagonistsDrug
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 group | Role | What they receive |
|---|---|---|
| No anticoagulation | Experimental | No oral anticoagulation, and no monitoring of the INR. Receives: Biological: No oral anticoagulation |
| Oral anticoagulation with vitamin K antagonists | Active comparator | 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. Receives: Drug: Oral anticoagulation with vitamin K antagonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start12 Jul 2017
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886962
- Sponsor's protocol ID
- 6396
- Acronym
- AVKDIAL
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2016
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02886962
- Acronym / sponsor ID
- AVKDIAL / 6396
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No anticoagulation | Experimental | Biological: No oral anticoagulationNo oral anticoagulation, and no monitoring of the INR. |
| Oral anticoagulation with vitamin K antagonists | Active comparator | Drug: Oral anticoagulation with vitamin K antagonistsVKA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No oral anticoagulationNo oral anticoagulation, and no monitoring of the INR. | Biological | No anticoagulation |
| Oral anticoagulation with vitamin K antagonistsVitamin 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 | Drug | Oral anticoagulation with vitamin K antagonists |
Primary outcome
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation
Time frame: 2 years
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing No oral anticoagulation and Oral anticoagulation with vitamin K antagonists in people with Kidney Failure, Chronic, run by University Hospital, Strasbourg, France at 25 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of severe bleedings and thrombosis of oral anticoagulation versus no anticoagulation in hemodialysis patients with atrial fibrillation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.