irregular heart beat
Conditions
Interventions
The Double-dummy approach will be used to achieve double-blind treatment.
Aspirin Arm will receive:
Active aspirin at a dose of 81mg once daily
and placebo-apixaban
Apixaban Arm will receive:
Active apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more
of: age >= 80, weight = 133 µmol/L or >= 1.5 mg/dL)
and placebo-aspirin
Sponsors
Population Health Research Institute of McMaster University and Hamilton Health Sciences Centre
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF 2. At least one episode of device-detected SCAF >= 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless >= 6 hours in duration 3. Age > 55 years 4. Risk Factor(s) for Stroke: Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors Other risk factors are: hypertension, CHF, diabetes, vascular disease (i.e. CAD, PAD or Aortic Plaque) and female
Exclusion criteria
Exclusion criteria: 1. Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting >= 6 minutes, with or without clinical symptoms 2. Mechanical valve prosthesis, deep vein thrombosis, recent pulmonary embolism or other condition requiring treatment with an anticoagulant 3. Contra-indication to apixaban or aspirin: a. Allergy to aspirin or apixaban b. Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with either a serum creatinine > 2.5 mg/dL [221 µmol/L] or a calculated creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Composite of stroke (including transient ischemic attack (TIA) with evidence of cerebral infarction on diffusion-weighted MRI) and systemic embolism Safety: Major bleeding as defined by the ISTH criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| * Ischemic stroke * Myocardial infarction * Vascular death * Total death (vascular and non-vascular) * Composite of stroke, myocardial infarction, systemic embolism and total death * Composite of stroke, myocardial infarction, systemic embolism, total death and major bleeding | — |
Countries
Netherlands
Outcome results
None listed