None listed
Conditions
Interventions
Drug : For patients randomly assigned to the NOAC group, the choice of which NOAC to use is at the discretion of the physician. Dosing recommendations are provided based on the label information for e
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients have to fulfill all of the following inclusion criteria: - noncardiac surgery in the past 35 days, with at least one of the following: o at least an overnight hospital admission after surgery o day surgery resulting in a large enough physiological insult to be able to cause perioperative AF, as judged by the local investigator; - =1 episode of clinically important perioperative AF during or after their surgery;* - sinus rhythm at the time of randomization; - any of the following high-risk criteria: o age 55-64 years, and having either established cardiovascular disease,** recent major vascular surgery,*** a CHA2DS2VASc score**** =3, or an elevated postoperative troponin level*****; o age 65-74 years, and having either established cardiovascular disease,** recent major vascular surgery;*** a CHA2DS2VASc score**** =2, or an elevated postoperative troponin level*****; or o age =75 years; and - provide written informed consent to participate. * Clinically important perioperative AF is defined as any of the following: 1. AF documented by a 12-lead electrocardiogram (ECG); 2. confirmed AF (e.g., rhythm strip) that results in angina, heart failure, symptomatic hypotension; ASPIRE-AF Protocol, Version 6.0, 2023-09-14 13/30 3. confirmed AF that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; or 4. confirmed continuous AF episode with a minimal duration of 1 hour. ** Cardiovascular disease is defined as a history of documented symptomatic or asymptomatic coronary artery disease, peripheral vascular disease, or stroke. *** Major vascular surgery is defined as all vascular surgery except arteriovenous shunt or vein stripping procedures. **** CHA2DS2VASc = Congestive heart failure or left ventricular (LV) dysfunction with an LV ejection fraction (LVEF) <40%, Hypertension, Age =75 years (2 points), Diabetes, and Stroke/TIA (2 points), Vascular disease (peripheral arterial disease, previous MI, aortic atheroma), Age =65 years, and female Sex category (10). *****An elevated postoperative troponin level is defined as any of the following: Troponin assay: Troponin threshold to define an elevated postoperative troponin (ng/l) Non-high-sensitivity troponin T: =30 High-sensitivity troponin T: 20 to <65 ng/L with an absolute change of at least 5 ng/L or a level =65 ng/L ADVIA Centaur Siemens high-sensitivity cardiac troponin I: =75 ARCHITECT STAT Abbott Laboratories high-sensitivity cardiac troponin I: =60 Other troponin I assays: value above the 99th percentile of the upper reference limit
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded: - A history of chronic (i.e., not transient) non-cardiac surgery-related atrial fibrillation (AF) prior to surgery. However, patients who meet this criterion but are considered eligible for participation in this clinical trial include the following: - Patients with a history of asymptomatic AF (i.e., AF detected only by an implanted device such as a pacemaker). - Patients with a history of previous perioperative AF (post-cardiac or non-cardiac surgery). - Patients with a history of transient AF following medical stress (e.g., sepsis, uncontrolled hyperthyroidism). - Individuals requiring long-term systemic anticoagulation (e.g., existing AF, mechanical heart valves, thrombotic history with antiphospholipid syndrome). - Individuals requiring long-term dual antiplatelet therapy. - Individuals for whom the use of oral anticoagulants is contraindicated. - Severe renal failure (CrCl < 20 mL/min). - Severe cirrhosis (i.e., chronic liver disease classified as Child-Pugh grade C). - Acute stroke within the past 14 days. - Cardiac surgery within the past 35 days. - A history of non-traumatic intracranial, intraocular, or spinal bleeding. - Hemorrhagic disorders or bleeding diathesis. - Individuals expected to be non-compliant with follow-up and/or trial medication. - Individuals with a known life expectancy of less than 1 year due to coexisting diseases. - Pregnant or breastfeeding women or women of childbearing potential who are not using effective contraception. - Individuals who have previously been enrolled in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, Physical examination(pulse rate, body weight) | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine measurement | — |
Countries
Korea, Republic of
Contacts
Public ContactMin-geong Jeon
Seoul National University Hospital
Outcome results
None listed