Antithrombotic Strategy Variability In ATrial Fibrillation and Obstructive Coronary Disease Revascularized With PCI - The AVIATOR 2 Registry

Completed

Conditions studied: Non-valvular Atrial Fibrillation

In brief

The purpose of this observational registry was to compare the safety and efficacy of an antithrombotic regimen comprising one single antiplatelet agent plus an oral anti-thrombotic versus those consisting of DAPT alone or DAPT plus oral antithrombotic therapy. This registry assessed whether the antithrombotic therapy intensity would vary positively with physician perceived ischemic risk at the time of percutaneous coronary intervention (PCI), and whether an inverse association would be observed with perceived bleeding risk. This study also evaluated the physician use of objective benefit-risk assessment scores and their influence on prescription of antithrombotic therapy in atrial fibrillation (AF) patients undergoing PCI. Additionally the study investigated whether patient perceived relevance and accessibility of anti-platelet and anticoagulant treatment regiments would predict treatment adherence and whether non-adherence would independently influence outcome. Approximately 514 subjects with non-valvular AF undergoing all-comer PCI were enrolled at 11 sites in North America and Europe. Follow-up was done via telephone by trained research coordinators at each participating site at 30 days, 6 months and 12 months.

Key facts

Study ID

NCT02362659

Run by

Icahn School of Medicine at Mount Sinai

People needed

514

Starts

2015-04-01

Expected to finish

2018-11-15

Last updated by the study team

2019-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of non-valvular atrial fibrillation during hospitalization.
• Preexisting atrial fibrillation.
• Successful all-comer percutaneous coronary intervention:
• Procedural success is defined as a reduction of residual luminal diameter stenosis to <50% without in-hospital death, AMI or the need for emergency CABG.
• Over 18 years of age
• Able to provide written informed consent

You may not qualify if…

• Atrial fibrillation due to reversible causes (e.g., thyrotoxicosis, pericarditis)
• Valvular atrial fibrillation secondary to severe mitral stenosis or prosthetic heart valve
• Women who are of childbearing potential Treatment with other investigational drugs or devices within 30 days before enrolment or planned use of investigational drugs or devices during the study
• Life expectancy <12 months due to non-cardiac comorbidities
• Active alcohol, drug abuse, psychosocial reasons making study participation impractical
• Severe renal insufficiency (calculated creatinine clearance < 30 mL/min) or dialysis
• Clinically overt stroke within the last 3 months
• Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, rivaroxaban, apixaban, edoxaban or warfarin

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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