Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)



Status:Completed
Conditions:Atrial Fibrillation, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/25/2018
Start Date:July 14, 2014
End Date:February 8, 2017

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A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion

Some people can develop an abnormal heart beat known as "Atrial fibrillation" or "AF" that
puts them at risk of developing clots in the heart. Those clots can travel in the blood
circulation to the brain and cause a brain attack ("a stroke"). To prevent those clots
forming, blood thinners (anti-coagulants) are used. Apixaban is a blood thinner that works by
stopping one of the blood substances required for clotting ("Factor Xa"). It is approved and
used to prevent clots forming in people with "AF". Other established blood thinners work by
stopping clotting substances being made, known as "Vitamin K antagonists" or "VKAs". An
example of this type is Warfarin (Coumadin). The good effects of all blood thinners are
preventing clots, and they may also have bad effects of increasing the chance of bleeding.
People with "AF", abnormal heart beat, may benefit from changing it back to a normal regular
rhythm, known medically as "cardioversion". When this is done, people are currently most
commonly treated with a "VKA" blood thinner (e.g. warfarin). The purpose of this study is to
assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin
in people with "AF" in whom an early cardioversion is planned.


Inclusion Criteria:

- Subjects with non-valvular atrial fibrillation (as documented by electrocardiogram
(ECG) at Visit 1) indicated for cardioversion and initiation of anticoagulation in
accordance with the approved local label. Subjects presenting with atrial flutter with
no evidence of atrial fibrillation are not eligible for enrolment.

- Age ≥18 years (Age ≥ 19 years for Korea only and Age ≥ 20 years for Japan only).

- Evidence of a personally signed and dated informed consent document indicating that
the subject (or their legally-recognized representative) has been informed of all
pertinent aspects of the study.

- The subject is willing to provide contact details for at least one alternate person
for study staff to contact regarding their whereabouts, should the subject be
lost-to-follow-up over the course of the study. (Subject to IRB/IEC approval)

- Female subjects of childbearing potential must agree to use a highly effective method
of contraception throughout the study and for at least 28 days after the last dose of
assigned treatment. A subject is of childbearing potential if, in the opinion of the
investigator, she is biologically capable of having children and is sexually active.

- Subjects who are willing and able to comply with scheduled visits, treatment plan, and
other study procedures.

Exclusion Criteria:

- Subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral)
immediately prior to randomization.

- Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved
local label.

- Severe haemodynamically compromised subjects requiring emergent cardioversion.

- Patients with hemodynamically significant mitral stenosis, mechanical or biological
prosthetic valve or valve repair.

- Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a
prosthetic heart valve).

- Simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel,
ticlopidine, prasugrel) or simultaneous treatment with both aspirin and ticagrelor.

- Pregnant females; breastfeeding females; females of childbearing potential who are
unwilling or unable to use a highly effective method of contraception as outlined in
this protocol for the duration of the study and for at least 28 days after last dose
of investigational product.

- Participation in other studies involving investigational drug(s) (Phases 1-4) within
30 days before the current study begins and/or during study participation. Note:
Subjects cannot be randomized into this study more than once.

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the investigator, would make the subject inappropriate for entry
into this study.

- Subjects who are investigational site staff members directly involved in the conduct
of the trial and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are BMS/Pfizer employees directly involved in the
conduct of the trial.
We found this trial at
63
sites
234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Alexandria, Louisiana 71301
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Altamonte Springs, Florida 32714
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Altamonte Springs, Florida 32714
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Birmingham, Alabama 35243
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Bristol, Pennsylvania 19007
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Bryn Mawr, Pennsylvania 19010
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chula Vista, California 91910
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Columbia, Missouri 65212
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Flushing, New York 11355
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Hackensack, New Jersey 07601
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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17800 Kedzie Avenue
Hazel Crest, Illinois 60429
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Hershey, Pennsylvania 17033
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Heusden-Zolder, Limburg
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Indianapolis, Indiana 46237
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Layton, Utah 84041
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125 East Maxwell Street
Lexington, Kentucky 40508
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310 South Limestone
Lexington, Kentucky 40508
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Louisville, Kentucky 40206
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550 South Jackson Street
Louisville, Kentucky 40202
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Louisville, Kentucky 40202
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323 East Chestnut Street
Louisville, Kentucky 40202
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Midlothian, Virginia 23114
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Minneapolis, Minnesota 55407
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New Brunswick, New Jersey 08903
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Oregon, Ohio 43616
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800 Spruce St
Philadelphia, Pennsylvania 19107
215-829-3000
Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Philadelphia, Pennsylvania 19141
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Richmond, Virginia 23225
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Royal Oak, Michigan 48073
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Saint Louis, Missouri 63141
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Toledo, Ohio 43606
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Tulsa, Oklahoma 74137
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1120 South Utica Avenue
Tulsa, Oklahoma 74104
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Worcester, Massachusetts 01655
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Yardley, Pennsylvania 19067
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