Trial · NCT02618577

Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes

NCT02618577, Phase 3, Terminated, Atrial Fibrillation Network; results first posted 2025-02-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes. Trials, record NCT02618577. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02618577

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes
NCT number: NCT02618577
Status: Terminated
Phases: Phase 3
Enrollment: 2,608 participants, actual
Lead sponsor: Atrial Fibrillation Network
Conditions: Atrial High Rate Episodes
Interventions: Edoxaban, ASA
First posted: 2015-12-01
Last updated: 2025-02-06
Other registries' IDs: eudract:2015-003997-33
Results first posted: 2025-02-06
Limitations and caveats: The trial does not have sufficient power to detect or rule out a small beneficial effect of oral anticoagulation on the prevention of stroke. The generalizability of these findings with edoxaban to other NOACs is not known.

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Composite of Stroke, Systemic Embolism, or Cardiovascular Death	28 months	Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.
Secondary	Components of the Primary Outcome, Stroke	28 months	Time from randomisation to the first occurrence of ischemic stroke; incidence of first occurence of outcome measure.
Secondary	Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)	28 months	PCI, CABG
Secondary	All-cause Death	28 months	All-cause death
Secondary	Major Bleeding Events	28 months	according to the International Society on Thrombosis and Haemostasis (ISTH) definitions
Secondary	Quality of Life Changes at 12 and 24 Months Compared to Baseline	Baseline, 12 months and 24 months.	Adjusted mean change from baseline at 12 and 24 months of Quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L): The resulting score of the UK index ranges from 1 (for the best state) to - 0.285 (for the worst state), with 5.1% of the states valued as worse than dead. EQ5D- VAS: visual-analogue scale (0 worst to 100 best). Subscales of the UK index score were combined by adding up EQ-5D-5L index values with STATA using the English (ENG) Devlin value set, Version 1.1 (Updated 01/12/2020). Karnofsky Performance Scale is an 11-point scale from 0 to 100 (0 worst to 100 best).
Secondary	Patient Satisfaction at 12 and 24 Months Compared to Baseline	Baseline, 12 months and 24 months.	Adjusted change from baseline at 12 and 24 months measured by the Perception of Anticoagulant Treatment Questionnaire: For convenience score, a 0 - 100 scale; for satisfaction score a 0 - 100 scale; for both scores, the higher the score, the higher the convenience/satisfaction.
Secondary	Cost Effectiveness and Health Resource Utilisation	28 months	estimated by quantification of relevant events, interventions, nights spent in hospital and cardiovascular therapies
Secondary	Autonomy Status	Baseline and 24 months	Autonomy status only in patients with stroke during study participation, assessed at 24 month by modified Rankin scale. (Score ranges from 1 to 8, a higher score indicates a higher grade of disability)
Secondary	Components of the Primary Outcome, Systemic Embolism	28 months	Time from randomisation to the first occurrence of systemic embolism; incidence of first occurence of outcome measure.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Composite of Stroke, Systemic Embolism, or Cardiovascular Death	28 months	The primary analysis is in the modified intention-to-treat population, consisting of all randomised patients with a qualifying AHRE and intake of at least one dose of study drug.	number of new events per 100 pat.-years	NUMBER
SECONDARY	Components of the Primary Outcome, Stroke	28 months		number of new events per 100 pat.-years	NUMBER
SECONDARY	Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)	28 months		number of new events per 100 pat.-years	NUMBER
SECONDARY	All-cause Death	28 months		number of new events per 100 pat.-years	NUMBER
SECONDARY	Major Bleeding Events	28 months		number of new events per 100 pat.-years	NUMBER
SECONDARY	Quality of Life Changes at 12 and 24 Months Compared to Baseline	Baseline, 12 months and 24 months.		adjusted mean change from baseline	NUMBER
SECONDARY	Patient Satisfaction at 12 and 24 Months Compared to Baseline	Baseline, 12 months and 24 months.		scores on a scale (with 95% Confidence I	NUMBER
SECONDARY	Cost Effectiveness and Health Resource Utilisation	28 months
SECONDARY	Autonomy Status	Baseline and 24 months	MoCA Stroke Severity in patients with a stroke estimated by the Modified Rankin Scale at FU24.	Scores on a scale	MEDIAN
SECONDARY	Components of the Primary Outcome, Systemic Embolism	28 months		number of new events per 100 pat.-years	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Composite of Stroke, Systemic Embolism, or Cardiovascular Death	Edoxaban	3.3	number of new events per 100 pat.-years
Composite of Stroke, Systemic Embolism, or Cardiovascular Death	ASA or Placebo	4.0	number of new events per 100 pat.-years
Components of the Primary Outcome, Stroke	Edoxaban	0.9	number of new events per 100 pat.-years
Components of the Primary Outcome, Stroke	ASA or Placebo	1.1	number of new events per 100 pat.-years
Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)	Edoxaban	3.6	number of new events per 100 pat.-years
Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)	ASA or Placebo	4.1	number of new events per 100 pat.-years
All-cause Death	Edoxaban	4.3	number of new events per 100 pat.-years
All-cause Death	ASA or Placebo	3.7	number of new events per 100 pat.-years
Major Bleeding Events	Edoxaban	2.1	number of new events per 100 pat.-years
Major Bleeding Events	ASA or Placebo	1.0	number of new events per 100 pat.-years

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Edoxaban	1,306
Overall Study	STARTED	ASA or Placebo	1,302
Overall Study	COMPLETED	Edoxaban	500
Overall Study	COMPLETED	ASA or Placebo	472
Overall Study	NOT COMPLETED	Edoxaban	806
Overall Study	NOT COMPLETED	ASA or Placebo	830

Source ClinicalTrials.gov

Adverse events2,664

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Edoxaban	12	1,306	13
other	Anaemia	Blood and lymphatic system disorders	ASA or Placebo	8	1,302	8
other	Blood disorder	Blood and lymphatic system disorders	Edoxaban	0	1,306	0
other	Blood disorder	Blood and lymphatic system disorders	ASA or Placebo	1	1,302	1
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Edoxaban	3	1,306	4
other	Iron deficiency anaemia	Blood and lymphatic system disorders	ASA or Placebo	2	1,302	2
other	Lymph node calcification	Blood and lymphatic system disorders	Edoxaban	1	1,306	1
other	Lymph node calcification	Blood and lymphatic system disorders	ASA or Placebo	0	1,302	0
other	Lymphadenopathy	Blood and lymphatic system disorders	Edoxaban	0	1,306	0
other	Lymphadenopathy	Blood and lymphatic system disorders	ASA or Placebo	2	1,302	2

1 to 10 of 2,664Source ClinicalTrials.gov

See all 2,664 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Edoxaban	142	1,306
Total, all-cause mortality	ASA or Placebo	125	1,302
Total, other adverse events	Edoxaban	718	1,306
Total, other adverse events	ASA or Placebo	662	1,302
Total, serious adverse events	Edoxaban	498	1,306
Total, serious adverse events	ASA or Placebo	467	1,302

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28760205	BACKGROUND	PubMed
31377792	BACKGROUND	PubMed
37622677	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Edoxaban vs ASA or Placebo: deaths from any cause	Trial comparisons
Edoxaban vs ASA or Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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