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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list