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) (EMANATE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02100228
First received: February 5, 2014
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Apixaban
Drug: Parenteral heparin and/or oral Vitamin K antagonist
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase IV Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-Valvular Atrial Fibrillation Undergoing Cardioversion

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Acute stroke [ Time Frame: Events will be collected up to 30 days post cardioversion ] [ Designated as safety issue: No ]
    An acute stroke is defined as a new focal neurological deficit of sudden onset, lasting at least 24 hours, that is not due to a readily identifiable non-vascular cause. This will be assessed by the Investigator.

  • Systemic embolism [ Time Frame: Events will be collected up to 30 days post cardioversion ] [ Designated as safety issue: No ]
    A clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which is supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. This will be assessed by the Investigator.

  • Major Bleeding [ Time Frame: Events will be collected up to 30 days post cardioversion ] [ Designated as safety issue: Yes ]
    Defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding with confirmatory imaging techniques which can detect the presence of blood. The definition of major bleeding is adapted from the International Society on Thrombosis and Hemostasis (ISTH) definition. This will be assessed by the Investigator.

  • Clinically Relevant Non-Major Bleeding [ Time Frame: Events will be collected up to 30 days post cardioversion ] [ Designated as safety issue: Yes ]
    The definition is adapted from International Society on Thrombosis and Hemostasis (ISTH) definition. This will be assessed by the Investigator.

  • All cause death [ Time Frame: Events will be collected up to 30 days post cardioversion ] [ Designated as safety issue: No ]
    Death


Secondary Outcome Measures:
  • Cardioversion Details [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
    The timing, type, and the attempts of cardioversion will be collected.

  • Length of in-hospital stay [ Time Frame: Number of hours will be collected from admission for cardioversion to 30 days post cardioversion. ] [ Designated as safety issue: No ]
    Length of in-hospital stay is defined as the number of hours from hospital admission to hospital discharge for cardioversion. Mean and median duration will be summarized.

  • Rhythm status [ Time Frame: Pre & post cardioversion and 30 days post cardioversion ] [ Designated as safety issue: No ]
    Rhythm status pre- and post cardioversion as recorded by ECG will be collected.


Estimated Enrollment: 1500
Study Start Date: June 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban Drug: Apixaban
Oral, 2.5 or 5 mg BID
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)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with non-valvular atrial fibrillation indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label.
  • Age ≥18 years.
  • 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.
  • 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 currently taking an oral anticoagulant.
  • Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label.
  • Severe haemodynamically compromised subjects requiring emergent cardioversion.
  • Clinically significant (moderate or severe) mitral stenosis.
  • Conditions other than atrial fibrillation that require chronic anticoagulation (eg. a prosthetic mechanical heart valve).
  • 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- - within 30 days before the current study begins and/or during study participation.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02100228

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Sponsors and Collaborators
Pfizer
Bristol-Myers Squibb
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100228     History of Changes
Other Study ID Numbers: B0661025, CV185-267
Study First Received: February 5, 2014
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
apixaban
oral anticoagulant
non-valvular atrial fibrillation
cardioversion

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Calcium heparin
Anticoagulants
Heparin
Vitamin K
Vitamins
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on July 24, 2014