NCT02761941

Brief Summary

The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (\>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Factors influencing on high INR values will be recorded and the aim is to seek out patients who have elevated risk of bleeding complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

3.6 years

First QC Date

May 3, 2016

Last Update Submit

May 4, 2016

Conditions

Anticoagulation

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    90 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with VKA for atrial fibrillation in the Southwest Finland hospital district area with INR value over 9.

You may qualify if:

  • VKA treatment, age \> 18, INR \>9,

You may not qualify if:

  • age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

RECRUITING

Study Officials

  • Juhani Airaksinen, Professor

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuija Vasankari, RN

CONTACT

+358 2 3130900tuija.vasankari@tyks.fi

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

FI(1)