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Anticoagulant

Uninterrupted apixaban for Atrial Fibrillation (AEIOU Trial)

Phase 4
Waitlist Available
Led By Matthew Reynolds, MD, MSc
Research Sponsored by Baim Institute for Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to 1 month post catheter ablation
Awards & highlights

Summary

The purpose of the prospective, randomized cohort in this study is to assess the safety and efficacy of 2 apixaban treatment strategies (uninterrupted versus interrupted) in subjects planned to undergo catheter ablation for the treatment of non-valvular atrial fibrillation (NVAF). Simultaneously, a retrospective cohort of 300 warfarin-treated individuals, identified by chart review, who are matched to the prospective randomized subjects, will be identified. The purpose of the retrospective warfarin cohort is to compare the efficacy and safety of warfarin(the current clinical practice) to that of apixaban (uninterrupted, interrupted, combined uninterrupted and interrupted).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to 1 month post catheter ablation
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to 1 month post catheter ablation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Number of Patients With Cardiovascular Death
Hemorrhage
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
+5 more

Side effects data

From 2017 Phase 4 trial • 300 Patients • NCT02608099
9%
Atrial fibrillation
7%
Arrhythmia supraventricular
5%
Catheter site pain
5%
Atrial flutter
5%
Nausea
5%
Catheter site haemorrhage
4%
Non-cardiac chest pain
3%
Back pain
3%
Dizziness
3%
Dyspnoea
3%
Catheter site haematoma
2%
Fluid retention
2%
Headache
2%
Hypertension
2%
Catheter site bruise
1%
Diastolic dysfunction
1%
Coronary artery disease
1%
Cardiac Failure Congestive
1%
Pneumonia Mycoplasmal
1%
Atrial Fibrillation
1%
Catheter Site Haemorrhage
1%
Vascular Pseudoaneurysm
1%
Urinary Retention
1%
Angina pectoris
1%
Dyspnoea Exertional
1%
Palpitations
1%
Incision site haemorrhage
1%
Catheter site swelling
1%
Incision site pain
1%
Periorbital haemorrhage
1%
Haemoglobin decreased
1%
International normalised ratio increased
1%
Decreased appetite
1%
Fluid overload
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Arthralgia
1%
Muscle spasms
1%
Musculoskeletal pain
1%
Migraine
1%
Paraesthesia
1%
Presyncope
1%
Haematuria
1%
Pollakiuria
1%
Urinary retention
1%
Transient ischaemic attack
1%
Tremor
1%
Diarrhoea
1%
Haematemesis
1%
Lip swelling
1%
Infusion site pain
1%
Oedema peripheral
1%
Cough
1%
Dyspnoea exertional
1%
Atrial Flutter
1%
Pyrexia
1%
Pneumonia mycoplasmal
1%
Procedural hypotension
1%
Procedural nausea
1%
Haemoptysis
1%
Rash pruritic
1%
Sinus Arrest
1%
Catheter Site Pain
1%
Atrial thrombosis
1%
Atrioventricular block first degree
1%
Pain
1%
Deep vein thrombosis
1%
Procedural vomiting
1%
Hypokalaemia
1%
Dental caries
1%
Anxiety
1%
Oropharyngeal pain
1%
Sinus arrest
1%
Fatigue
1%
Sinusitis
1%
Cardiac failure congestive
1%
Arrhythmia Supraventricular
1%
Fluid Overload
1%
Pericarditis
1%
Sinus tachycardia
1%
Ear pain
1%
Visual impairment
1%
Catheter site discharge
1%
Upper respiratory tract infection
1%
Urinary tract infection
1%
Vascular pseudoaneurysm
1%
Electrocardiogram QT prolonged
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interrupted Apixaban
Uninterrupted Apixaban

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Uninterrupted apixabanExperimental Treatment1 Intervention
Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Group II: Interrupted apixabanActive Control1 Intervention
Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
FDA approved

Find a Location

Who is running the clinical trial?

Baim Institute for Clinical ResearchLead Sponsor
28 Previous Clinical Trials
55,350 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
817 Patients Enrolled for Atrial Fibrillation
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,345 Total Patients Enrolled
72 Trials studying Atrial Fibrillation
1,646,220 Patients Enrolled for Atrial Fibrillation
Matthew Reynolds, MD, MScPrincipal InvestigatorLahey Hospital & Medical Center
~31 spots leftby Sep 2025
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