Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atri… (NCT01938248) | Clinical Trial Compass
CompletedPhase 4
Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation
United States4,012 participantsStarted 2015-05
Plain-language summary
This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF
✓. At least one episode of 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.
✓. Age ≥ 55 years
✓. Risk Factor(s) for Stroke:
Exclusion criteria
✕. Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms
✕. Mechanical valve prosthesis, deep vein thrombosis, recent pulmonary embolism or other condition requiring treatment with an anticoagulant
✕. Contra-indication to apixaban or aspirin:
✕. Allergy to aspirin or apixaban
✕. 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)
✕. Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, platelet count \< 50,000/mm3 or hemoglobin \< 10 g/dL, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
What they're measuring
1
Composite of ischemic stroke and systemic embolism
Timeframe: event driven, duration of follow-up - mean follow-up time anticipated: 3 years