Warfarin - How Good Are we at Maintaining Target Range ?

Atrial Fibrillation Clinical Trial

Official title:

Observational Record Linkage Study Investigating Incidence of Adverse Events in Patients Anti-coagulated for Lone Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01081327
• Other study ID #: ELD007
• Status: Completed
• Start date: March 2010
• Est. completion date: March 1, 2016

Study information

• Verified date: March 2010
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with atrial fibrillation are often anticoagulated with Warfarin. Warfarin has a narrow therapeutic window requiring frequent monitoring. This study aims to investigate the incidence of adverse events in the "real world" for patients receiving Warfarin for lone atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: March 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Prescription for Warfarin

• Atrial Fibrillation

Exclusion Criteria:

• Other conditions associated with increased risk of embolisation e.g. rheumatic valve disease, atrial mixoma.

• Conditions with increased risk of bleeding.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United Kingdom	Centre for Cardiovascular and Lung Biology, Univeristy of Dundee	Dundee

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Complication	Any bleeding event requiring hospitalisation and / or blood transfusion. Any death attributable to bleeding i.e. Intracerebral bleed.	10 years
Primary	Cardiovascular outcome	Ischaemic event e.g. Cerebral infarction / Myocardial infarction / death attributed to ischaemic event	10 years