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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02415400
• Date of registration: 09/04/2015
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: 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
• Scientific 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
• Date of first enrolment: June 4, 2015
• Target sample size: 4614
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415400
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, 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, Venezuela, Virgin Islands (U.S.)

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 95 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Coronary Syndromes

Intervention(s)

Drug: vitamin K antagonist

Other: Acetylsalicylic acid placebo

Drug: Acetylsalicylic acid

Drug: Apixaban

Primary Outcome(s)

The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period [Time Frame: Approximately 6 months]

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]

Secondary Outcome(s)

The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA [Time Frame: Approximately 6 months]

The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin [Time Frame: Approximately 6 months]

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]

Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA [Time Frame: Approximately 6 months]

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]

Secondary ID(s)

2014-002004-24

CV185-316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke Clinical Research Institute

Pfizer

Results

• Results available: Yes
• Date Posted: 07/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02415400