A Phase III Study of Apixaban in Patients With Atrial Fibrillation

NCT00496769

Last updated date
Study Location
Mobile Heart Specialists, Pc
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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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
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female

- Age of 50 years or older

- Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)

- At least 1 of the following risk factors for stroke:

- Prior stroke or transient ischemic attack

- Age of 75 years or older

- Arterial hypertension on treatment

- Diabetes mellitus

- Heart failure (New York Health Authority Class 2 or greater at time of enrollment)

- Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment

- Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)

- Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

- Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued

- Vitamin K antagonist therapy not previously used but expected unsuitable

Key

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


- Women who are pregnant or breast feeding


- Women of child bearing potential who are unwilling to meet the study requirements for
pregnancy testing or are unwilling or unable to use an acceptable method to avoid
pregnancy


- Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis


- Valvular disease requiring surgery


- Planned ablation procedure for atrial fibrillation to be performed within 3 months


- Conditions other than atrial fibrillation that require chronic anticoagulation (such
as, prosthetic mechanical heart valve, venous thromboembolism)


- Patients with serious bleeding in the last 6 months or at high risk for bleeding,
including but not limited to those with:


- Active peptic ulcer disease


- Platelet count <100,000/mm^3 or hemoglobin <10g/dL


- Recent stroke (within 10 days)


- Documented hemorrhagic tendencies or blood dyscrasias


- Current alcohol or drug abuse or psychosocial reasons that make study participation
impractical


- Severe comorbid condition with life expectancy <1 year


- Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a
calculated creatinine clearance <25 mL/min is excluded


- Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of
normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative
causative factor [such as Gilbert's syndrome] is identified)


- Allergy or adverse reaction to acetylsalicylic acid


- Required treatment with a thienopyridine (clopidogrel or ticlopidine)


- Prisoners or participants who are compulsory detained (involuntarily incarcerated)


- Use of an investigational drug or device within the past 30 days or prior
randomization into an apixaban clinical study


- Patients who are compulsorily detained for treatment for a psychiatric or physical
illness

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase III Study of Apixaban in Patients With Atrial Fibrillation
Official Title  ICMJE Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial
Brief Summary The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.
Detailed Description An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Apixaban
    Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
    Other Name: BMS-562247
  • Drug: Acetylsalicylic acid
    Tablets, oral, 81-324 mg, once daily, up to 156 weeks
Study Arms  ICMJE
  • Experimental: Apixaban
    Intervention: Drug: Apixaban
  • Active Comparator: Acetylasalicylic acid
    Intervention: Drug: Acetylsalicylic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 22, 2013)
6421
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2007)
5600
Actual Study Completion Date  ICMJE May 25, 2017
Actual Primary Completion Date November 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Male and female
  • Age of 50 years or older
  • Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
  • At least 1 of the following risk factors for stroke:

    • Prior stroke or transient ischemic attack
    • Age of 75 years or older
    • Arterial hypertension on treatment
    • Diabetes mellitus
    • Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
    • Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
    • Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
  • Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

    • Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
    • Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
  • Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
  • Valvular disease requiring surgery
  • Planned ablation procedure for atrial fibrillation to be performed within 3 months
  • Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
  • Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:

    • Active peptic ulcer disease
    • Platelet count <100,000/mm^3 or hemoglobin <10g/dL
    • Recent stroke (within 10 days)
    • Documented hemorrhagic tendencies or blood dyscrasias
  • Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
  • Severe comorbid condition with life expectancy <1 year
  • Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
  • Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
  • Allergy or adverse reaction to acetylsalicylic acid
  • Required treatment with a thienopyridine (clopidogrel or ticlopidine)
  • Prisoners or participants who are compulsory detained (involuntarily incarcerated)
  • Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
  • Patients who are compulsorily detained for treatment for a psychiatric or physical illness
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   India,   Indonesia,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Norway,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Hungary,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00496769
Other Study ID Numbers  ICMJE CV185-048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP