Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay Higher Among Those Aged Over 75 Years

Atrial Fibrillation Clinical Trial

— AOD-SA  

Official title:

Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay (Xaban) Higher Among Those Aged Over 75 Years, as AOD for Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894450
• Other study ID #: RC14_0402
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: September 8, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Age = 75 years

• Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor)

• In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation

• In whom hemostasis tests will be prescribed as part of usual care

• Patient has given its verbal agreement

Exclusion criteria

Patients with the following criteria may not be included:

• Patients refusing to participate in the study

• Patients under guardianship

• Inability to obtain the date and time of the last dose of xaban

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• blood test
bioassay xaban

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bioassay direct oral anticoagulants		Baseline	No