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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)

Last updated on April 12, 2018

FOR MORE INFORMATION
Study Location
Brookwood Medical Center
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02100228
Pfizer
Completed
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)

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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)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Atrial Fibrillation
  • Drug: Apixaban
    Oral, 2.5 or 5 mg BID
  • Drug: Parenteral heparin and/or oral Vitamin K antagonist
    Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)
  • Experimental: Apixaban
    Intervention: Drug: Apixaban
  • Active Comparator: Parenteral heparin and/or oral Vitamin K antagonist
    Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)
    Intervention: Drug: Parenteral heparin and/or oral Vitamin K antagonist
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1500
February 2017
February 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Romania,   Spain,   Sweden,   United States
 
 
NCT02100228
B0661025
CV185-267 ( Other Identifier: Alias Study Number )
2014-001231-36 ( EudraCT Number )
EMENATE ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Bristol-Myers Squibb
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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