NCT02563639

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

September 21, 2015

Last Update Submit

February 25, 2019

Conditions

Atrial Fibrillation

Keywords

newly diagnosedparoxysmalpersistent

Outcome Measures

Primary Outcomes (1)

  • Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs

    Name of antithrombotic drug

    12 months

Secondary Outcomes (6)

  • Safety of Apixaban as assessed by MACCE, Haemorrhagic complications, Ischemic clinical events, Stroke, Systemic embolism, Hospitalisations for stroke, cardiac reasons or bleeding complications

    12 months

  • Subjective Quality of Life

    12 months

  • Comparison of antithrombotic therapy for atrial fibrillation: Dose of drugs

    12 months

  • Comparison of antithrombotic therapy for atrial fibrillation: Duration of treatment

    12 months

  • Comparison of antithrombotic therapy for atrial fibrillation: Contraindications for anticoagulation

    12 months

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-valvular atrial fibrillation (newly diagnosed, paroxysmal, permanent or persistent)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ludwigshafen

Ludwigshafen, D-67063, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Uwe Zeymer, Prof. Dr.

    Klinikum Ludwigshafen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 30, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2018

Study Completion

December 20, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

DE(1)