Phase 3
Completed N=984
Study of DU-176b Aged 80 Years or Older
Source: ClinicalTrials.gov NCT02801669 ↗Enrolled (actual)
984
Serious AEs
46.6%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo — 15; 44 Participants — p=0.0003
◆ Published Evidence
Established
26citations · ~9 / year
Antithrombotic treatment after stroke due to intracerebral haemorrhage.
Summary
The purpose of this study is to evaluate the efficacy and safety of edoxaban in patients with non-valvular NVAF aged 80 years or older who are ineligible for available oral anticoagulation therapy.
Linked Publications (5)
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Antithrombotic treatment after stroke due to intracerebral haemorrhage.
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Effect of 15-mg Edoxaban on Clinical Outcomes in 3 Age Strata in Older Patients With Atrial Fibrillation: A Prespecified Subanalysis of the ELDERCARE-AF Randomized Clinical Trial.
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Efficacy and Safety of Low-Dose Edoxaban by Body Weight in Very Elderly Patients With Atrial Fibrillation: A Subanalysis of the Randomized ELDERCARE-AF Trial.
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Laboratory Test Predictors for Major Bleeding in Elderly (≥80 Years) Patients With Nonvalvular Atrial Fibrillation Treated With Edoxaban 15 mg: Sub-Analysis of the ELDERCARE-AF Trial.
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Association of Edoxaban Pharmacokinetics With Bleeding in Older Patients With Atrial Fibrillation Treated With Low-Dose Edoxaban: A Post Hoc Analysis of a Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Composite Endpoint of Stroke and Systemic Embolic Events (SEE) in Participants Who Were Administered DU-176b Compared With Placebo |
15; 44 | 0.0003 sig |
| PRIMARY Number of Participants With Stroke and Systemic Embolic Events (SEE), Including Subcomponents of Stroke and Composite Event of Ischemic Stroke and SEE in Participants Who Were Administered DU-176b Compared With Placebo |
12; 40; 3; 6; 12; 39 | — |
| SECONDARY Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and Death Due to Cardiovascular in Participants Who Were Administered DU-176b Compared With Placebo |
52; 72 | — |
| SECONDARY Number of Participants With a Composite Endpoint of a Major Adverse Cardiovascular Event (MACE) in Participants Who Were Administered DU-176b Compared With Placebo |
51; 72 | — |
| SECONDARY Number of Participants With a Composite Endpoint of Stroke, Systemic Embolic Events (SEE), and All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo |
74; 98 | — |
| SECONDARY Number of Participants With Net Clinical Benefit in Participants Who Were Administered DU-176b Compared With Placebo |
87; 103 | — |
| SECONDARY Number of Participants With All-Cause Mortality in Participants Who Were Administered DU-176b Compared With Placebo |
66; 69 | — |
| SECONDARY Number of Participants With Major Bleeding During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo |
20; 11; 2; 4; 0; 2 | — |
| SECONDARY Number of Participants With Major Bleeding or Clinically Relevant Non-major Bleedings During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo |
97; 62; 81; 52 | — |
| SECONDARY Number of Participants With All Bleeding Events and Minor Bleeding Events During On-Treatment Period in Participants Who Were Administered DU-176b Compared With Placebo |
241; 202; 190; 177 | — |
| SECONDARY Plasma Concentration of DU-176 in Participants Who Were Administered DU-176b |
17.3; 93.3; 93.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Nonvalvular Atrial Fibrillation (NVAF) aged 80 years or older who are ineligible for available oral anticoagulation therapy
Exclusion Criteria
- Patients with active bleeding
- Patients who have poorly controlled hypertension
- Patients who have liver dysfunction accompanied with disorder of blood coagulation
Data sourced from ClinicalTrials.gov (NCT02801669) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.