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Comparison · NCT02618577-deaths

Edoxaban vs ASA or Placebo: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Edoxaban vs ASA or Placebo: deaths from any cause. Trial comparisons, record NCT02618577-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02618577-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1090.0930.127wilson
Risk in group 20.0960.08120.113wilson
Risk difference, group 1 minus group 20.0127-0.01060.0361newcombe hybrid score
Risk ratio, group 1 over group 21.130.9021.42log
Odds ratio, group 1 over group 21.150.8911.48log
Number needed to harm, for one more death from any cause on Edoxaban than on ASA or Placebo78.6from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Edoxaban
Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics:~Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.~Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics:~Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
1421,306EG000
Group 2ASA or Placebo
Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator~ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
1251,302EG001

Harm

What it counts
Total, all-cause mortality
Time frame
(S)AEs were collected during a median follow-up time of 21 months after the baseline visit for all patients until the trial was terminated, i.e. (S)AEs were collected through study completion. (S)AEs were collected on a 6 monthly basis after baseline visit. After the announcement of early termination of the trial due to safety reasons and futility, a final visit was conducted within 3 months for all active patients including a final (Serious) Adverse Event assessment.

Source ClinicalTrials.gov

Trial

Title
Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
NCT number
NCT02618577
Phases
PHASE3
Conditions
Atrial High Rate Episodes
Interventions
Edoxaban, ASA
Lead sponsor
Atrial Fibrillation Network
Results first posted
2025-02-06

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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