Apixaban in Atrial Fibrillation Registry

Atrial Fibrillation Clinical Trial

— APAF  

Official title:

APAF Apixaban in Atrial Fibrillation Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563639
• Other study ID #: CV185-404
• Status: Completed
• Start date: September 2015
• Est. completion date: December 20, 2018

Study information

• Verified date: February 2019
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.

Description:

Atrial fibrillation (AF) confers a substantial risk of mortality and morbidity from stroke and thromboembolism, and this common cardiac arrhythmia represents a major healthcare burden in Europe. Stroke prevention is central to the management of AF patients, with oral anticoagulation (OAC) using well-controlled adjusted dose vitamin K antagonists or novel OACs being recommended for patients with AF with ≥1 stroke risk factors. Also, the 2012 focused update of the ESC guidelines strongly advocates a clinical practice shift so that the initial decision step now is the identification of 'truly low risk' patients, essentially those age<65 without any stroke risk factors (both male and female), who do not need any antithrombotic therapy. The ESC guidelines only recommend use of the CHA2DS2-VASc score for stroke risk assessment, and the 'low risk' patients are defined as those with a CHA2DS2-VASc score=0 (males) or score=1 (females). Subsequent to this initial step of identifying the low risk patients, effective stroke prevention (which is essentially OAC) can then be offered to AF patients with ≥1 stroke risk factors, with treatment decisions made in consultation with patients and incorporating their preferences. Despite these recommendations, a substantial number of patients with AF is not treated with OAC. On the other hand, patients with AF and low risk are being "overtreated", receiving OAC despite a CHADS-VASc score of 0. Therefore, this registry will determine, if patients with non-valvular AF are treated ac-cording to current guidelines.

Apixaban is an oral factor Xa inhibitor, which has been tested in a number of indications. In the AVERROES study in patients with non-valvular atrial fibrillation deemed not suitable for treatment with a vitamin-K antagonist apixaban compared to aspirin reduced the incidence of stroke and systemic embolism without increasing bleeding complications. In the large ARISTOTELE study apixaban was superior to warfarin, it re-duced the primary endpoint of stroke and systemic embolism caused less bleeding and reduced all-cause mortality. Subsequently apixaban has been approved by the European health authorities for the use in patients with atrial fibrillation. It is therefore of interest to determine use of apixaban in real life with respect to patient selection, adherence to therapy and midterm efficacy and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5015
• Est. completion date: December 20, 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Non-valvular atrial fibrillation

• In hospitals or specialized or non-specialised office-based centres

• Written informed consent for participation in observational study (incl. telephone follow-ups)

• Not simultaneously participating in any randomized trial

Exclusion Criteria: No exclusion criteria

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Klinikum Ludwigshafen	Ludwigshafen

Sponsors (2)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs	Name of antithrombotic drug	12 months
Secondary	Safety of Apixaban as assessed by MACCE, Haemorrhagic complications, Ischemic clinical events, Stroke, Systemic embolism, Hospitalisations for stroke, cardiac reasons or bleeding complications	MACCE (death / MI / stroke); Haemorrhagic complications (major / minor bleeding); Ischemic clinical events (non-fatal MI, cardiac death, etc.); Stroke (ischemic, haemorrhagic); Systemic embolism; Hospitalisations for stroke, cardiac reasons or bleeding complications	12 months
Secondary	Subjective Quality of Life	Questionnaire (EQ-5D-5L)	12 months
Secondary	Comparison of antithrombotic therapy for atrial fibrillation: Dose of drugs	Dose of antithrombotic drug	12 months
Secondary	Comparison of antithrombotic therapy for atrial fibrillation: Duration of treatment	Duration of treatment [months]	12 months
Secondary	Comparison of antithrombotic therapy for atrial fibrillation: Contraindications for anticoagulation	Relative and absolute contraindications to anticoagulation at baseline and history	12 months
Secondary	Comparison of antithrombotic therapy for atrial fibrillation:Selection of anticoagulant	Basis for the selection of the anticoagulant	12 months