Warfarin - How Good Are we at Maintaining Target Range ? | NCT01081327

Studies
Warfarin - How Good Are we at Maintaining Target Range ?

NCT01081327

Sponsor

University of Dundee

Status

Completed

Last Update Posted

Dec 3, 2018Actual

Enrollment

5,000Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 1, 2016Actual

Completion Date

Mar 1, 2016Actual

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Mar 4, 2010

First Posted Date

Mar 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2018

Last Update Posted Date

Dec 3, 2018Actual

Name	Class
NHS Tayside	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Actual

Label	Type	Description	Intervention Names
Patients receiving Warfarin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving Warfarin for lone atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Cardiovascular and Lung Biology, Univeristy of Dundee		Dundee		DD1 9SY	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided