NL-OMON52976已完成4 期
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 个研究点目标入组 280 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •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
- •includes, but is not limited to: prior intracranial hemorrhage, active peptic
- •ulcer disease, clinically significant thrombocytopenia or anemia, recent stroke
- •within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
- •d. Moderate to severe hepatic impairment
- •e. Ongoing need for combination therapy with aspirin and clopidogrel (or other
- •combination of two platelet inhibitors)
- •f. Meets criteria for requiring lower dose of apixaban AND also has ongoing
- •need for strong inhibitors of CYP 3A4 or P-glycoprotein (e.g., ketoconazole,
- •itraconazole, ritonavir or clarithromycin)
- •g. Ongoing need for strong dual inducers of CYP 3A4 or P-glycoprotein (e.g.,
- •rifampin, carbamazepine, phenytoin, St. John*s wort)
- •4. Received an investigational drug in the past 30 days
- •5. Participants considered by the investigator to be unsuitable for the study
- •for any of the following reasons:
- •* Not agreeable for treatment with either aspirin or apixaban or anticipated to
- •have poor compliance on study drug treatment
- •* Unwilling to attend study follow-up visits
- •* Life expectancy less than 2 years due to concomitant disease
- •6. Women who are pregnant, breast-feeding or of child-bearing potential without
- •an acceptable form of contraception in place (sterilization, hormonal
- •contraceptives, intrauterine device, barrier methods or abstinence)
研究者
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