Condition category
Circulatory System
Date applied
27/03/2006
Date assigned
10/04/2006
Last edited
19/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Justin Nowell

ORCID ID

Contact details

St George's Healthcare NHS Trust
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/Q0803/36

Study information

Scientific title

Anticoagulation following tissue aortic valve replacement

Acronym

AFTAV

Study hypothesis

Null hypothesis:
There is no difference in rates of neurological events following aortic valve replacement (AVR) with reference to oral anticoagulation.

Ethics approval

No provided at time of registration

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Aortic valve disease

Intervention

Three groups: warfarin therapy for 90 days, aspirin therapy for 90 days, control group (no medication)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Neurological events
2. Stroke

Secondary outcome measures

Thrombus formation

Overall trial start date

01/05/2006

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing tissue aortic valve replacement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Patients who require aspirin or warfarin therapy on established medical grounds
2. Patients unable to take warfarin or aspirin

Recruitment start date

01/05/2006

Recruitment end date

01/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's Healthcare NHS Trust
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

St George's Healthcare NHS Trust (UK)

Sponsor details

Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

St George's Heart Science Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/10/2016: No publications found in PubMed, verifying study status with principal investigator.