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A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

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ClinicalTrials.gov Identifier: NCT02415400
Recruitment Status : Completed
First Posted : April 14, 2015
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Collaborators:
Pfizer
Duke Clinical Research Institute
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 9, 2015
First Posted Date  ICMJE April 14, 2015
Results First Submitted Date  ICMJE November 7, 2019
Results First Posted Date  ICMJE February 7, 2020
Last Update Posted Date February 7, 2020
Actual Study Start Date  ICMJE June 4, 2015
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
  • The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period [ Time Frame: Approximately 6 months ]
    Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
  • The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period [ Time Frame: Approximately 6 months ]
    Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo. N is the number of participants with aspirin or placebo. n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major or Clinically Relevant Non-Major (CRNM) bleeding during the treatment period between Apixaban and VKA [ Time Frame: Approximately 6 months ]
    time to first occurrence of ISTH major or CRNM bleeding during the time the patient is taking the medicine which is 6 months
  • Time to first occurrence of major or CRNM bleeding during the treatment period between No aspirin and aspirin [ Time Frame: Approximately 6 months ]
    time to first occurrence of ISTH major or CRNM bleeding during the time the patient is taking the medicine which is 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2020)
  • Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA [ Time Frame: Approximately 6 months ]
    Time to first occurrence during the time the participants were treated with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
  • The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA [ Time Frame: Approximately 6 months ]
    Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
  • The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin [ Time Frame: Approximately 6 months ]
    Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo. N is the number of participants treated with aspirin or placebo. n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment. Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
  • The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA [ Time Frame: Approximately 6 months ]
    Time to first occurrence during the 6-month treatment period with Apixaban or VKA. N is the number of participants treated with Apixaban or VKA. n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment. Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
  • The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin [ Time Frame: Approximately 6 months ]
    Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo. N is the number of participants treated with aspirin or placebo. n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period. Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • Superiority on major + CRNM bleeding between Apixaban versus VKA [ Time Frame: Approximately 6 months ]
    time to first occurrence during the time the patient is taking the medicine which is 6 months
  • The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization) between Apixaban versus VKA [ Time Frame: Approximately 6 months ]
    time to first occurrence during the time the patient is taking the medicine which is 6 months
  • First re-hospitalization for any cause between Apixaban versus VKA [ Time Frame: Approximately 6 months ]
    time to first occurrence during the time the patient is taking the medicine which is 6 months
  • The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization) between aspirin versus placebo [ Time Frame: Approximately 6 months ]
    time to first occurrence during the time the patient is taking the medicine which is 6 months
  • First re-hospitalization for any cause between aspirin versus placebo [ Time Frame: Approximately 6 months ]
    time to first occurrence during the time the patient is taking the medicine which is 6 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart
Official Title  ICMJE An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention
Brief Summary The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.
Detailed Description

Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.

Masking:

Apixaban: Open label.

VKA: Open label.

Acetylsalicylic acid film coated tablet: Double Blinded.

Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE
  • Drug: Apixaban
    Other Name: BMS-562247
  • Drug: vitamin K antagonist
  • Drug: Acetylsalicylic acid
    Other Name: Aspirin 81 mg
  • Other: Acetylsalicylic acid placebo
    Other Name: aspirin placebo
Study Arms  ICMJE
  • Active Comparator: Apixaban
    5 mg or 2.5 mg Apixaban tablets orally twice per day
    Intervention: Drug: Apixaban
  • Active Comparator: Vitamin K Antagonist
    VKA tablets orally once daily
    Intervention: Drug: vitamin K antagonist
  • Placebo Comparator: Acetylsalicylic acid film coated tablet
    81 mg Acetylsalicylic acid film coated tablet orally once daily
    Intervention: Drug: Acetylsalicylic acid
  • Placebo Comparator: Placebo matching Acetylsalicylic acid film coated tablet
    Placebo matching Acetylsalicylic acid film coated tablet once daily
    Intervention: Other: Acetylsalicylic acid placebo
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: January 10, 2019)
4614
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
4600
Actual Study Completion Date  ICMJE November 10, 2018
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
  • Planned use of antiplatelet agents for at least 1 to 6 months
  • Males and Females ≥ 18 years of age
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

  • Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
  • Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
  • Patients with a history of intracranial hemorrhage
  • Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
  • Patients with known ongoing bleeding and patients with known coagulopathies
  • Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 95 Years   (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,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States,   Virgin Islands (U.S.)
Removed Location Countries Czech Republic,   Venezuela
 
Administrative Information
NCT Number  ICMJE NCT02415400
Other Study ID Numbers  ICMJE CV185-316
2014-002004-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE
  • Pfizer
  • Duke Clinical Research Institute
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2020

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