A Study Comparing Apixaban to Vitamin K Antagonist for the Prevention of Stroke or Systemic Embolism and Bleeding in Patients with Non-valve Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

Overview

About this study

The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

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
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
- A calculated creatinine clearance < 30 mL/min
A history of intracranial hemorrhage
Have had or will undergo coronary arterial bypass graft (CABG) for their index acute coronary syndrome event
Known ongoing bleeding and known coagulopathies
Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator F Fortuin, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

F Fortuin, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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