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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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VISIONAIRE (Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including 1500 patients with atrial fibrillation or atrial flutter and advanced chronic kidney disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Active Comparator | Full-dose anticoagulation with adjusted dose (target INR 2.0-3.0) warfarin. |
|
| Edoxaban | Experimental | Dose will be based on label from Brazil considering adjustment for low CrCl, that is, 30 mg QD. |
|
| No anticoagulation | No Intervention | No oral anticoagulation should be used |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulant Oral | Drug | Patients will be anticoagulated following with 30 mg QD edoxaban or adjusted dose warfarin for a target INR 2.0-3.0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint | Time to first occurrence of the composite of stroke or systemic embolism | 24 months (median follow-up) |
| Primary safety endpoint: | Major or clinically relevant non-major bleeding according to the ISTH criteria | 24 months (median follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy endpoints | Time to first occurrence of the composite of: death, ischemic or undetermined stroke, or systemic embolism | 24 months (median follow-up) |
| Secondary efficacy endpoints |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory endpoint | Quality of life by EQ-5D | 12 months |
| Exploratory endpoint | Access site bleeding | 24 months (median follow-up) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilian Barbosa, MBA | Contact | +55 11 98966 0550 | lilian@bcri.org.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ana Nery | Active, not recruiting | Salvador | Estado de Bahia | Brazil | ||
| Instituto de Cardiologia do DF |
After publication of study primary results in a peer-reviewed scientific medical journal, interested parts in data sharing are welcome to contact the corresponding author directly.
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Patients will be randomized in 1:1:2 to warfarin, edoxaban or no OAC, stratified by renal replacement status.
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All study endpoints will be assessed by an independent Clinical Events Committee (CEC), whose members will be unaware of randomized treatment assignment.
|
Time to first occurrence of the composite of: CV death, MI, or stroke
| 24 months (median follow-up) |
| Secondary efficacy endpoints | Time to first occurrence of the composite of: all-cause death, MI, systemic embolism, or stroke | 24 months (median follow-up) |
| Secondary efficacy endpoints | All cause death | 24 months (median follow-up) |
| Secondary safety endpoint | Time to first occurrence of major bleeding (ISTH) | 24 months (median follow-up) |
| Secondary safety endpoint | Time to first occurrence of GUSTO moderate or severe bleeding | 24 months (median follow-up) |
| Secondary safety endpoint | Time to first occurrence of TIMI minor and major bleeding | 24 months (median follow-up) |
| Secondary safety endpoint | Fatal or intra-cranial bleeding | 24 months (median follow-up) |
| Net clinical endpoint | Time to first occurrence of CV death, MI, stroke, systemic embolism, fatal bleeding or bleeding into a critical organ | 24 months (median follow-up) |
| Exploratory endpoint | Fistula or catheter thrombosis | 24 months (median follow-up) |
| Exploratory endpoint | Fistula or catheter failure | 24 months (median follow-up) |
| Active, not recruiting |
| Brasília |
| Federal District |
| Brazil |
| Hospital Universitário Maria Aparecida Pedrossian - EBSERH | Active, not recruiting | Campo Grande | Mato Grosso do Sul | Brazil |
| Sociedade Beneficente de Senhoras Hospital Sírio-Libanês | Active, not recruiting | São Paulo | São Paulo | Brazil |
| Hospital Universitário São Francisco na Providência de Deus | Recruiting | Bragança Paulista | Brazil |
|
| Santa Casa de Misericórdia de Ponta Grossa | Recruiting | Ponta Grossa | Brazil |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D051436 | Renal Insufficiency, Chronic |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000925 | Anticoagulants |
| C552171 | edoxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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