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CompletedNCT02608099AEIOUUpdated Mar 17, 2020Results posted

Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation

A Phase 4 interventional study of Interrupted apixaban and Uninterrupted apixaban in Atrial Fibrillation, sponsored by Baim Institute for Clinical Research. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Baim Institute for Clinical Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Prospective, Randomized Cohort

Subjects undergoing ablation for NVAF who meet all eligibility criteria and sign informed consent will be enrolled into the study. Subjects will be treated with apixaban for ≥21 days prior to the ablation procedure (for subjects already on apixaban for ≥21 days, it is not necessary to wait 21 days before the ablation procedure. Apixaban dose will be 5 mg b.i.d. per product label, or 2.5 mg b.i.d. in subjects with 2 or more of the following: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥1.5 mg/dL.

Eligible subjects will then be randomized in a 1:1 ratio to 2 peri-procedural treatment strategies:

  • Uninterrupted treatment: administer the evening apixaban dose on the day prior to the procedure; administer the morning apixaban dose on the day of the procedure; administer heparin bolus before transseptal puncture to maintain a target activated clotting time [ACT] > 300 seconds; administer the evening apixaban dose after the procedure if there were no peri-procedural complications that necessitate withholding anticoagulation for longer duration.
  • Interrupted treatment: administer the evening apixaban dose on the day prior to the procedure; do not administer the morning apixaban dose on the day of the procedure; administer heparin bolus before transseptal puncture to maintain a target ACT > 300 seconds; administer the evening apixaban dose after the procedure if there were no peri-procedural complications that necessitate withholding anticoagulation for longer duration.

Randomization will take place prior to the procedure (on the day of the procedure or up to 3 days prior to the procedure) and will be stratified by site.

It is anticipated that up to 360 subjects may be enrolled in order to evaluate a total of 300 randomized subjects (150 subjects per treatment arm):

Randomized subjects will continue treatment with apixaban for 1 month post procedure.

Retrospective, Warfarin Cohort In addition, a chart review of 300 warfarin-treated patients who underwent catheter ablation for NVAF on or after September 1, 2013 in the enrolling centers and who have documented follow-up in the medical record for ≥ 30 days post-ablation procedure will be performed. Patient records for warfarin-treated individuals who meet the applicable inclusion/exclusion criteria and who are matched 1:1 to a subject in the prospective, randomized cohort for age (+/- 5 years), gender and atrial fibrillation (AF) type (paroxysmal vs. persistent), will be identified. Sites will document key demographic and outcome variables. This review will be performed in a blinded manner such that site personnel are blinded to the outcome of each retrospective subject during the subject selection process. Only pre-existing data will be collected for the analysis of this cohort.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial fibrillation
  • Non-valvular atrial fibrillation
  • Catheter ablation
  • Apixaban
  • Warfarin
  • Harvard Clinical Research Institute
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed informed consent.
  2. >18 years of age.
  3. NVAF with planned catheter ablation treatment.
  4. Planned anticoagulant treatment for at least 1 month after the index procedure.
  5. Subject agrees to all required follow-up procedures and visits.

  6. For women of childbearing potential (WOCBP):

    • Must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug.
    • Must not be breastfeeding
    • Must agree to follow instructions for method(s) of contraception for a total of 33 days post-treatment completion.
  7. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a total of 93 days post-treatment completion.
  8. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, WOCBP must still undergo pregnancy testing as described in this section.

Exclusion criteria

Exclusion Criteria:

  1. History of significant bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  2. Known hypersensitivity or contraindication to heparin or apixaban.
  3. Subjects with mechanical prosthetic heart valves.
  4. History of cerebrovascular accident or transient ischemic attach (TIA) within the last 6 months.
  5. Prior intracranial hemorrhage.
  6. End-stage renal failure (creatinine clearance rate \<15 mL/minute or on dialysis treatment).
  7. Hepatic disease associated with coagulopathy.
  8. Current or expected systemic treatment with strong dual inducers of CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort).
  9. Current or expected systemic treatment with dual antiplatelet therapy, other anticoagulants, or fibrinolytics.
  10. Planned or expected surgery, or other invasive procedure that would require interruption of anticoagulation within 1 month of the catheter ablation procedure.
  11. Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  12. Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the trial.
  13. Platelet count ≤100,000/mm3.
  14. Hemoglobin level \<9 g/dL.
  15. Any active bleeding.
  16. Prisoners or subjects who are involuntarily incarcerated.
  17. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Interrupted apixaban

    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.

    Drug: Interrupted apixaban

  • Experimental
    Uninterrupted apixaban

    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.

    Drug: Uninterrupted apixaban

Interventions

  • DrugInterrupted apixaban

    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.

    Also known as: Interrupted Eliquis

  • DrugUninterrupted apixaban

    Intervention description: 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.

    Also known as: Uninterrupted Eliquis

05

What researchers measure

Primary outcomes

  1. Number of Patients With Clinically-Significant Bleeding

    Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

    Time frame: Randomization to 1 month post catheter ablation

  2. Number of Patients With Thrombotic Events

    Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

    Time frame: Randomization to 1 month post catheter ablation

Secondary outcomes

  1. Number of Patients With Composite of Major Bleeding and Thrombotic Events

    Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

    Time frame: Randomization to 1 month post catheter ablation

  2. Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

    Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

    Time frame: Randomization to 1 month post catheter ablation

Other outcomes

  1. Number of Patients With Clinically-Significant Bleeding

    Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

    Time frame: Enrollment to 1 month post catheter ablation

  2. Number of Patients With Major Bleeding

    Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

    Time frame: Randomization to 1 month post catheter ablation

  3. Number of Patients With Major Bleeding

    Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

    Time frame: Enrollment to 1 month post catheter ablation

  4. Number of Patients With Thrombotic Events

    Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

    Time frame: Enrollment to 1 month post catheter ablation

  5. Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

    Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

    Time frame: Enrollment to 1 month post catheter ablation

  6. Number of Patients With Composite of Major Bleeding and Thrombotic Events

    Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher.

    Time frame: Enrollment to 1 month post catheter ablation

  7. Number of Patients With TIAs or Non-Hemorrhagic Strokes

    Number of Patients who had TIAs or non-hemorrhagic strokes.

    Time frame: Enrollment to 1 month post catheter ablation

  8. Number of Patients With TIAs or Non-Hemorrhagic Strokes

    This measurement includes TIAs or non-hemorrhagic strokes.

    Time frame: Randomization to 1 month post catheter ablation

  9. Number of Patients With Death

    Death is included in this measurement.

    Time frame: Enrollment to 1 month post catheter ablation

  10. Number of Patients With Cardiovascular Death

    Cardiovascular death is included in this measurement.

    Time frame: Enrollment to 1 month post catheter ablation

  11. Number of Patients With Death

    Death is included in this measurement.

    Time frame: Randomization to 1 month post catheter ablation

  12. Number of Patients With Cardiovascular Death

    Cardiovascular death is included in this measurement.

    Time frame: Randomization to 1 month post catheter ablation

06

Results

Posted Mar 17, 2020

Participant flow

Participant flow — Overall Study
MilestoneInterrupted ApixabanUninterrupted Apixaban
Started148152
Safety149151
Completed145150
Not completed32
Withdrew: Ablation procedure not initiated32

Outcome measures

PrimaryNumber of Patients With Clinically-Significant Bleeding

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Clinically-Significant Bleeding
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Clinically-Significant Bleeding1417
PrimaryNumber of Patients With Thrombotic Events

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Thrombotic Events
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Thrombotic Events00
SecondaryNumber of Patients With Composite of Major Bleeding and Thrombotic Events

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Composite of Major Bleeding and Thrombotic Events
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Composite of Major Bleeding and Thrombotic Events32
SecondaryNumber of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events1417
Other pre-specifiedNumber of Patients With Clinically-Significant Bleeding

Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Clinically-Significant Bleeding
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Clinically-Significant Bleeding1717
Other pre-specifiedNumber of Patients With Major Bleeding

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Major Bleeding
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Major Bleeding32
Other pre-specifiedNumber of Patients With Major Bleeding

Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Major Bleeding
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Major Bleeding32
Other pre-specifiedNumber of Patients With Thrombotic Events

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Thrombotic Events
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Thrombotic Events00
Other pre-specifiedNumber of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events

Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events1417
Other pre-specifiedNumber of Patients With Composite of Major Bleeding and Thrombotic Events

Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events. Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Composite of Major Bleeding and Thrombotic Events
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Composite of Major Bleeding and Thrombotic Events32
Other pre-specifiedNumber of Patients With TIAs or Non-Hemorrhagic Strokes

Number of Patients who had TIAs or non-hemorrhagic strokes.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With TIAs or Non-Hemorrhagic Strokes
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With TIAs or Non-Hemorrhagic Strokes11
Other pre-specifiedNumber of Patients With TIAs or Non-Hemorrhagic Strokes

This measurement includes TIAs or non-hemorrhagic strokes.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With TIAs or Non-Hemorrhagic Strokes
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With TIAs or Non-Hemorrhagic Strokes11
Other pre-specifiedNumber of Patients With Death

Death is included in this measurement.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Death
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Death00
Other pre-specifiedNumber of Patients With Cardiovascular Death

Cardiovascular death is included in this measurement.

Time frame:
Enrollment to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Cardiovascular Death
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Cardiovascular Death00
Other pre-specifiedNumber of Patients With Death

Death is included in this measurement.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Death
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Death00
Other pre-specifiedNumber of Patients With Cardiovascular Death

Cardiovascular death is included in this measurement.

Time frame:
Randomization to 1 month post catheter ablation
Reported as:
Count of participants · Participants
Number of Patients With Cardiovascular Death
ParticipantsInterrupted ApixabanUninterrupted Apixaban
Number of Patients With Cardiovascular Death00

Adverse events

Collected over 1 Month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Interrupted Apixaban0/149 (0%)14/149 (9.4%)72/149 (48.3%)
Uninterrupted Apixaban0/151 (0%)15/151 (9.9%)75/151 (49.7%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventInterrupted ApixabanUninterrupted Apixaban
Atrial FibrillationCardiac disorders2/1493/151
Arrhythmia SupraventricularCardiac disorders2/1491/151
Atrial FlutterCardiac disorders2/1491/151
HypotensionVascular disorders0/1492/151
Urinary Tract InfectionInfections and infestations0/1492/151
Catheter Site HaemorrhageGeneral disorders1/1490/151
Pneumonia MycoplasmalInfections and infestations1/1490/151
Vascular PseudoaneurysmInjury, poisoning and procedural complications1/1491/151
Fluid OverloadMetabolism and nutrition disorders1/1490/151
DyspnoeaRespiratory, thoracic and mediastinal disorders1/1490/151
Most frequent other events
Showing 10 of 116
Most frequent other events
EventInterrupted ApixabanUninterrupted Apixaban
Atrial fibrillationCardiac disorders13/1497/151
Arrhythmia supraventricularCardiac disorders10/1499/151
Catheter site haemorrhageGeneral disorders8/1495/151
Atrial flutterCardiac disorders7/1493/151
NauseaGastrointestinal disorders7/1497/151
Catheter site painGeneral disorders7/1493/151
Non-cardiac chest painGeneral disorders6/1496/151
Catheter site haematomaGeneral disorders5/1492/151
Back painMusculoskeletal and connective tissue disorders5/1490/151
Oedema peripheralGeneral disorders2/1495/151

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Interrupted ApixabanUninterrupted ApixabanTotal
Mean64.3 ± 10.362.8 ± 9.963.5 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Interrupted ApixabanUninterrupted ApixabanTotal
Female484997
Male97101198
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Interrupted ApixabanUninterrupted ApixabanTotal
Hispanic or Latino123
Not Hispanic or Latino134143277
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Interrupted ApixabanUninterrupted ApixabanTotal
American Indian or Alaska Native011
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American426
White133141274
More than one race000
Unknown or Not Reported000
Body Mass Index
Body Mass Index(kg/m2)Interrupted ApixabanUninterrupted ApixabanTotal
Mean30.46 ± 5.60730.58 ± 6.44130.52 ± 6.036
07

Study locations

19 sites
  • Site 0020
    Huntsville, Alabama 35801, United States
  • Site 0005
    Mission Viejo, California 92690, United States
  • Site 0012
    New Haven, Connecticut 06501, United States
  • Site 0011
    Trumbull, Connecticut 06611, United States
  • Site 0016
    Pensacola, Florida 32501, United States
  • Site 0014
    West Des Moines, Iowa 50266, United States
  • Site 0018
    Bangor, Maine 04401, United States
  • Site 0004
    Scarborough, Maine 04074, United States
  • Site 0008
    Boston, Massachusetts 02118, United States
  • Site 0001
    Burlington, Massachusetts 01805, United States
  • Site 0006
    Kansas City, Missouri 64111, United States
  • Site 0021
    Omaha, Nebraska 68131, United States
  • Site 0019
    Albuquerque, New Mexico 87101, United States
  • Site 0002
    Toledo, Ohio 43615, United States
  • Site 0007
    Oklahoma City, Oklahoma 73104, United States
  • Site 0009
    Philadelphia, Pennsylvania 19019, United States
  • Site 0010
    Charleston, South Carolina 29401, United States
  • Site 0017
    Austin, Texas 78705, United States
  • Site 0003
    Richmond, Virginia 23219, United States
08

References and documents

Publications

  • Bawazeer GA, Alkofide HA, Alsharafi AA, Babakr NO, Altorkistani AM, Kashour TS, Miligkos M, AlFaleh KM, Al-Ansary LA. Interrupted versus uninterrupted anticoagulation therapy for catheter ablation in adults with arrhythmias. Cochrane Database Syst Rev. 2021 Oct 21;10(10):CD013504. doi: 10.1002/14651858.CD013504.pub2. PubMed 34674223 ↗
  • Reynolds MR, Allison JS, Natale A, Weisberg IL, Ellenbogen KA, Richards M, Hsieh WH, Sutherland J, Cannon CP. A Prospective Randomized Trial of Apixaban Dosing During Atrial Fibrillation Ablation: The AEIOU Trial. JACC Clin Electrophysiol. 2018 May;4(5):580-588. doi: 10.1016/j.jacep.2017.11.005. Epub 2017 Dec 20. PubMed 29798783 ↗

Study documents

  • Statistical analysis plan · Oct 28, 2016
  • Study protocol · Sep 2, 2015

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02608099
Lead sponsor
Baim Institute for Clinical Research
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Nov 18, 2015
Start date
Nov 2015
Primary completion
Apr 2017
Completion
Apr 2017
Results posted
Mar 17, 2020
Last update
Mar 17, 2020

Study contacts

Matthew Reynolds, MD, MSc
principal investigator · Lahey Hospital & Medical Center
Christopher P Cannon, MD
principal investigator · Harvard Clinical Research Organization and Cardiovascular Division Brigham and Women's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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