A Comparison of Apixaban Versus Aspirin for Preventing Stroke in Patients With Pacemakers (ARTESiA)
This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in pacemaker patients with sub-clinical atrial fibrillation and additional risk factors for stroke.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Apixaban for the Reduction of Thrombo-Embolism Due to Sub-Clinical Atrial Fibrillation|
- Composite of ischemic stroke and systemic embolism [ Time Frame: event driven duration - mean follow-up time anticipated: 3 years ] [ Designated as safety issue: No ]
- Major bleeding [ Time Frame: event driven duration - mean follow-up time anticipated: 3 years ] [ Designated as safety issue: Yes ]Major bleeding defined as: bleeding into a critical organ, requiring surgery, associated with at least a 2 g/dL drop in hemoglobin or requiring the transfusion of at least 2 units of packed red blood cells.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Aspirin 80-100 mg once daily
aspirin 80 - 100 mg once daily
Apixaban, 5 mg twice daily (or 2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
Other Name: Eliquis
There are over sixty thousand Canadians with pacemakers or implanted defibrillators. More than 40% of these patients will develop sub-clinical atrial fibrillation (SCAF), which is a short-lasting, typically asymptomatic arrhythmia that would not be detected by means other than a modern, dual-chamber pacemaker. Only 15% of patients with SCAF also have clinical atrial fibrillation (AF) and until recently, the significance of isolated SCAF was debated. However; our group published the ASSERT trial, which demonstrated that in patients with hypertension, but without clinical AF, SCAF ≥ 6 minutes in duration was associated with a 2.5-fold increased risk of stroke; which among patients with CHA2DS2-VASC score > 3 was associated with a stroke risk of 2.75% per year. However; the optimal approach to stroke prevention for patients with SCAF is controversial and oral anticoagulation (OAC) is usually not employed. As OAC can prevent 60-80% of ischemic strokes in patients with clinical AF, it is critical that we determine its roll in patients with SCAF.
Many patients with pacemakers and implanted defibrillators are followed semi-annually by cardiologists and nurses in device clinics and many of them have a CHA2DS2-VASC score > 3. They represent a large, high-risk and easily identifiable group of patients who are highly compliant with follow-up. ARTESiA will enroll 3,719 patients with a pacemaker or implanted defibrillator, a CHA2DS2-VASC score > 3 and at least one episode of SCAF ≥ 6 minutes who do not have a history of clinical AF and who do not have a contra-indication to oral anticoagulation. Patients will be randomized to receive either the oral anticoagulant apixaban or aspirin, in a double-blind, double-dummy fashion and will be followed for the primary outcome of ischemic stroke or systemic embolism.
ARTESiA will help define the role of OAC in patients with pacemakers and defibrillations who have SCAF; providing clinicians with important guidance for this common problem. However; the implications of ARTESiA go beyond the pacemaker population. New cardiac rhythm monitoring technologies are increasingly being used in clinical practice and suggest a high prevalence of SCAF among older individuals without pacemakers, but with cardiovascular risk factors. The results of ARTESiA will give insights for this much larger and rapidly growing group of patients.
|Contact: Heather Beresh, M.Sc||905-527-4322 ext email@example.com|
|Contact: Ellison Themeles, M.Sc||905-527-4322 ext firstname.lastname@example.org|
|Principal Investigator:||Jeff Healey, M.D.||Population Health Research Institute|
|Principal Investigator:||Stuart Connolly, M.D.||Population Health Research Institute|
|Principal Investigator:||Marco Alings, M.D.||Working Group Cardiovascular Research Netherlands|