Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub- Clinical Atrial fibrillation (ARTESiA)

  • STATUS
    Recruiting
  • sponsor
    Bristol-Myers Squibb, Pfizer, Medtronic and the Canadian Institutes
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Updated on 24 November 2020
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diabetes
stroke
atrial fibrillation
vascular disease
apixaban
cardiac monitoring
atrial flutter
embolism

Summary

Apixaban for the Reduction of Thrombo-Embolism in patients with Device-Detected Sub- Clinical Atrial fibrillation (ARTESiA)

Description

To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.

There are no direct benefits to you as a result of your participation in this study. However, your participation in this study may add to the medical knowledge about the use of these types of medications for reducing risk of stroke in patients with pacemaker or ICD or ICM detected episodes of SCAF. In the future, other people with a similar condition may benefit from the knowledge obtained from this study.

Details
Condition Atrial Fibrillation, Atrial Fibrillation (Pediatric)
Clinical Study IdentifierTX150571
Sponsor Bristol-Myers Squibb, Pfizer, Medtronic and the Canadian Institutes
Last Modified on24 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 55 yrs and 0 yrs?
Gender: Male or Female
Do you have any of these conditions: Atrial Fibrillation or Atrial Fibrillation (Pediatric)?
Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF
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
Age ≥ 55 years
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)
female

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, recent (within past 6 months) deep vein thrombosis or pulmonary embolism or other condition requiring treatment with an anticoagulant
Allergy to aspirin or apixaban
Severe renal insufficiency (serum creatinine > 2.5 mg/dL [221 µmol/L] or a calculated creatinine clearance < 25 ml/min)
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)
Moderate to severe hepatic impairment
Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors)
Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
Ongoing need for strong dual inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
Received an investigational drug in the past 30 days
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
Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sterilization, abstinence or other method with less than 1% failure rate)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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