APIXABAN FOR THE REDUCTION OF THROMBO-EMBOLISM IN PATIENTS WITH DEVICE-DETECTED SUB-CLINICAL ATRIAL FIBRILLATIO
- Conditions
- irregular heart beat10007521
- Registration Number
- NL-OMON52976
- Lead Sponsor
- Population Health Research Institute of McMaster University and Hamilton Health Sciences Centre
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: Composite of stroke (including transient ischemic attack (TIA) with<br /><br>evidence of cerebral infarction on diffusion-weighted MRI) and systemic embolism<br /><br>Safety: Major bleeding as defined by the ISTH criteria</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Ischemic stroke<br /><br>* Myocardial infarction<br /><br>* Vascular death<br /><br>* Total death (vascular and non-vascular)<br /><br>* Composite of stroke, myocardial infarction, systemic embolism and total death<br /><br>* Composite of stroke, myocardial infarction, systemic embolism, total death<br /><br>and major bleeding</p><br>