NL-OMON52976
Completed
Phase 4
APIXABAN FOR THE REDUCTION OF THROMBO-EMBOLISM IN PATIENTS WITH DEVICE-DETECTED SUB-CLINICAL ATRIAL FIBRILLATION - ARTESIA
Population Health Research Institute of McMaster University and Hamilton Health Sciences Centre0 sites280 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Population Health Research Institute of McMaster University and Hamilton Health Sciences Centre
- Enrollment
- 280
Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
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 \< 25 ml/min is excluded)
- •c. Serious bleeding in the last 6 months or at high risk of bleeding (this
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