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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 : June 11, 2020
Sponsor:
Collaborators:
Pfizer
Duke Clinical Research Institute
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: Apixaban Drug: vitamin K antagonist Drug: Acetylsalicylic acid Other: Acetylsalicylic acid placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4614 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : June 4, 2015
Actual Primary Completion Date : November 10, 2018
Actual Study Completion Date : November 10, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Apixaban
5 mg or 2.5 mg Apixaban tablets orally twice per day
 Drug: Apixaban
Other Name: BMS-562247
Active Comparator: Vitamin K Antagonist
VKA tablets orally once daily
 Drug: vitamin K antagonist
Placebo Comparator: Acetylsalicylic acid film coated tablet
81 mg Acetylsalicylic acid film coated tablet orally once daily
 Drug: Acetylsalicylic acid
Other Name: Aspirin 81 mg
Placebo Comparator: Placebo matching Acetylsalicylic acid film coated tablet
Placebo matching Acetylsalicylic acid film coated tablet once daily
 Other: Acetylsalicylic acid placebo
Other Name: aspirin placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415400


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Duke Clinical Research Institute
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] August 21, 2018
Statistical Analysis Plan  [PDF] November 28, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02415400    
Other Study ID Numbers: CV185-316
2014-002004-24 ( EudraCT Number )
First Posted: April 14, 2015    Key Record Dates
Results First Posted: February 7, 2020
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Aspirin
Vitamin K
Apixaban
Vitamins
Micronutrients
 Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics