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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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).
Eligible Conditions
- Atrial Fibrillation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to 1 month post catheter ablation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to 1 month post catheter ablation
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 moreSide effects data
From 2017 Phase 4 trial • 300 Patients • NCT026080999%
Atrial fibrillation
7%
Arrhythmia supraventricular
5%
Catheter site haemorrhage
5%
Catheter site pain
5%
Atrial flutter
5%
Nausea
4%
Non-cardiac chest pain
3%
Catheter site haematoma
3%
Back pain
3%
Dizziness
3%
Dyspnoea
2%
Catheter site bruise
2%
Fluid retention
2%
Headache
2%
Hypertension
1%
Diastolic dysfunction
1%
Catheter site discharge
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%
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
2,690 Previous Clinical Trials
4,097,240 Total Patients Enrolled
72 Trials studying Atrial Fibrillation
1,650,720 Patients Enrolled for Atrial Fibrillation
Matthew Reynolds, MD, MScPrincipal InvestigatorLahey Hospital & Medical Center
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