Warfarin - How Good Are we at Maintaining Target Range ?

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2010 by University of Dundee.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

NHS Tayside

Information provided by:

University of Dundee

ClinicalTrials.gov Identifier:

NCT01081327

First received: March 4, 2010

Last updated: June 24, 2010

Last verified: March 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	March 4, 2010
Last Updated Date	June 24, 2010
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2010)	Bleeding Complication [ Time Frame: 10 years ] [ Designated as safety issue: Yes ] Any bleeding event requiring hospitalisation and / or blood transfusion. Any death attributable to bleeding i.e. Intracerebral bleed. Cardiovascular outcome [ Time Frame: 10 years ] [ Designated as safety issue: Yes ] Ischaemic event e.g. Cerebral infarction / Myocardial infarction / death attributed to ischaemic event
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01081327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Warfarin - How Good Are we at Maintaining Target Range ?
Official Title ^ICMJE	Observational Record Linkage Study Investigating Incidence of Adverse Events in Patients Anti-coagulated for Lone Atrial Fibrillation.
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Ecologic or Community Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	All patients receiving Warfarin for lone atrial fibrillation
Condition ^ICMJE	Atrial Fibrillation
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Patients receiving Warfarin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	5000
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01081327
Other Study ID Numbers ^ICMJE	ELD007
Has Data Monitoring Committee	No
Responsible Party	Dr. Douglas Elder, University of Dundee
Study Sponsor ^ICMJE	University of Dundee
Collaborators ^ICMJE	NHS Tayside
Investigators ^ICMJE	Not Provided
Information Provided By	University of Dundee
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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