Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
ARTESIA
Leitung: Prof. Dr. Michael Böhm

ARTESIA

In patients with evidence of device-detected sub-clinical atrial fibrillation (SCAF) and additional risk factors for stroke, treatment with apixaban compared with aspirin will reduce the risk of the composite of stroke and systemic embolism.

INCLUSION Criteria (gekürzt)

  • 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 (Atrial rate > 175/min if an atrial lead is present), but no single episode > 24 hours in duration at any time prior to enrollment. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration
  • Age ≥ 18 years
  • CHA2DS2-VASc score of ≥ 4

EXCLUSION Criteria (gekürzt)

  • Clinical atrial fibrillation documented by surface ECG  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 Serious bleeding in the last 6 months or at high risk of
  • Moderate to severe hepatic impairment
  • Ongoing need for combination therapy with aspirin and clopidogrel
  • 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
  • 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

Ansprechpartner

Dr. med.
Pavlicek, 
Valerie
Oberärztin, Leitung interventionelle Elektrophysiologie und spezielle Rhythmologie
06841 - 16 - 15912
06841 - 16 - 15910
Pavlicek Valerie
Prof. Dr. med.
Ukena, 
Christian
Leiter Rhythmologie
06841 - 16 - 15912
06841 - 16 - 15910
Ukena Christian

Ansprechpartner im Studienzentrum

Neurath, 
Barbara
Leitung Studienambulanz (Geb. 24)
06841 - 16 - 21202
06841 - 16 - 21415
Neurath Barbara
Dr.
Wachter, 
Angelika
Stellv. Leitung Studienzentrum (Geb. 24)
06841 - 16 - 23318
06841 - 16 - 21415
Wachter Angelika