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OpenTrials
Completed

NCT Number: NCT02415400

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

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution, Buenos Aires, BUA, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apixaban

Drug

Other names: BMS-562247

Vitamin K antagonist

Drug

acetylsalicylic acid

Drug

Other names: Aspirin 81 mg

Acetylsalicylic acid placebo

Other

Other names: aspirin placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Duke Clinical Research Institute
  • Pfizer

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2015
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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