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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 : Active, not recruiting
First Posted : April 14, 2015
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Pfizer
Duke Clinical Research Institute
Information provided by (Responsible Party):
Bristol-Myers Squibb

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4138 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
Estimated Primary Completion Date : December 27, 2018
Estimated Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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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

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


  Show 698 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Duke Clinical Research Institute
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02415400     History of Changes
Other Study ID Numbers: CV185-316
2014-002004-24 ( EudraCT Number )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Atrial Fibrillation
Acute Coronary Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Vitamins
Vitamin K
Aspirin
Apixaban
Micronutrients
Growth Substances
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