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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Hemodialysis patients with non valvular atrial fibrillation receiving warfarin |
|
| rivaroxaban | Experimental | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od |
|
| rivaroxaban + K2 | Experimental | Hemodialysis patients with non valvular atrial fibrillation receiving rivaroxaban 10 mg od + vitamin K2 supplements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban 10 MG Oral Tablet | Drug | replacement of warfarin by rivaroxaban |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite of fatal and non-fatal stroke and other cardiovascular events | composite of fatal and non-fatal stroke and other cardiovascular events | through study completion, on average 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| death rate | cause of death | through study completion, on average 3 years |
| safety: incidence of life-threatening, major and minor bleeding | incidence of life-threatening, major and minor bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rogier Caluwe, MD | OLV Hospital Aalst, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Hospital | Aalst | 9300 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38189593 | Derived | 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. | |
| 33753537 | Derived | De 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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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| MK-7 2000µg thrice weekly | Dietary Supplement | dietary supplement of vitamin K2 MK-7 2000µg thrice weekly |
|
| Vitamin K Antagonist - Drug | Drug | treatment with a vitamin K antagonist |
|
| through study completion, on average 3 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |