Atrial FibrillationPhase 4NCT03799822
Oral Anticoagulation in Hemodialysis
A Phase 4 study testing Rivaroxaban 10 MG Oral Tablet, MK-7 2000µg thrice weekly and Vitamin K Antagonist - Drug in people with Atrial Fibrillation, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial summary
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban 10 MG Oral Tablet, MK-7 2000µg thrice weekly and Vitamin K Antagonist - Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2017to 1 Oct 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inclusion in the trial with clinicaltrials.gov identifier NCT02610933
- signed informed consent for this extension trial
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.
Read the detailed description
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban 10 MG Oral Tablet, MK-7 2000µg thrice weekly, Vitamin K Antagonist - Drug
- Keywords
- hemodialysis, rivaroxaban, vitamin K2
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban 10 MG Oral TabletDrug
replacement of warfarin by rivaroxaban
MK-7 2000µg thrice weeklyDietary supplement
dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
Vitamin K Antagonist - DrugDrug
treatment with a vitamin K antagonist
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Hemodialysis patients with non valvular atrial fibrillation receiving warfarin Receives: Drug: Vitamin K Antagonist - Drug |
| rivaroxaban | Experimental | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od Receives: Drug: Rivaroxaban 10 MG Oral Tablet |
| rivaroxaban + K2 | Experimental | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements Receives: Drug: Rivaroxaban 10 MG Oral Tablet; Dietary Supplement: MK-7 2000µg thrice weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of fatal and non-fatal stroke and other cardiovascular events
composite of fatal and non-fatal stroke and other cardiovascular events
Measured: through study completion, on average 3 years
Secondary outcomes (2)
death rate
cause of death
Measured: through study completion, on average 3 years
safety: incidence of life-threatening, major and minor bleeding
incidence of life-threatening, major and minor bleeding
Measured: through study completion, on average 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 May 2017
- Primary completion15 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogier Caluwe, Onze Lieve Vrouw Hospital
- Investigators
- Rogier Caluwe, MD, Principal investigator, OLV Hospital Aalst, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799822
- Sponsor's protocol ID
- OLV 2014/065
- Status last verified
- Oct 2020
- First submitted
- 7 Jan 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PubMed 38189593De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22.
PubMed 33753537
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03799822
- Acronym / sponsor ID
- OLV 2014/065
- Conditions
- Atrial Fibrillation
- Keywords
- hemodialysis, rivaroxaban, vitamin K2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- 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.
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.
Detailed description
The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.
After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Vitamin K Antagonist - DrugHemodialysis patients with non valvular atrial fibrillation receiving warfarin |
| rivaroxaban | Experimental | Drug: Rivaroxaban 10 MG Oral TabletHemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od |
| rivaroxaban + K2 | Experimental | Drug: Rivaroxaban 10 MG Oral Tablet, Dietary Supplement: MK-7 2000µg thrice weeklyHemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- inclusion in the trial with clinicaltrials.gov identifier NCT02610933
- signed informed consent for this extension trial
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Rivaroxaban 10 MG Oral Tabletreplacement of warfarin by rivaroxaban | Drug | rivaroxaban, rivaroxaban + K2 |
| MK-7 2000µg thrice weeklydietary supplement of vitamin K2 MK-7 2000µg thrice weekly | Dietary supplement | rivaroxaban + K2 |
| Vitamin K Antagonist - Drugtreatment with a vitamin K antagonist | Drug | Control |
Primary outcome
composite of fatal and non-fatal stroke and other cardiovascular events
Time frame: through study completion, on average 3 years
composite of fatal and non-fatal stroke and other cardiovascular events
2 secondary outcomes
death rate
Time frame: through study completion, on average 3 years
safety: incidence of life-threatening, major and minor bleeding
Time frame: through study completion, on average 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 38189593Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
- Derived from this study: PubMed 33753537De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22.
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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.
Rogier Caluwe, MD principal investigator
OLV Hospital Aalst, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban 10 MG Oral Tablet, MK-7 2000µg thrice weekly and Vitamin K Antagonist - Drug in people with Atrial Fibrillation, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
composite of fatal and non-fatal stroke and other cardiovascular events (time frame: through study completion, on average 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03799822, which also lists 2 linked publications.
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 3 Nov 2020.