Anticoagulation following tissue aortic valve replacement

ISRCTN ISRCTN51663857
DOI https://doi.org/10.1186/ISRCTN51663857
Secondary identifying numbers 06/Q0803/36
Submission date
27/03/2006
Registration date
10/04/2006
Last edited
19/10/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Justin Nowell
Scientific

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

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleAnticoagulation following tissue aortic valve replacement
Study acronymAFTAV
Study objectivesNull hypothesis:
There is no difference in rates of neurological events following aortic valve replacement (AVR) with reference to oral anticoagulation.
Ethics approval(s)No provided at time of registration
Health condition(s) or problem(s) studiedAortic valve disease
InterventionThree groups: warfarin therapy for 90 days, aspirin therapy for 90 days, control group (no medication)
Intervention typeOther
Primary outcome measure1. Neurological events
2. Stroke
Secondary outcome measuresThrombus formation
Overall study start date01/05/2006
Completion date01/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteriaPatients undergoing tissue aortic valve replacement
Key exclusion criteria1. Patients who require aspirin or warfarin therapy on established medical grounds
2. Patients unable to take warfarin or aspirin
Date of first enrolment01/05/2006
Date of final enrolment01/05/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

St George's Healthcare NHS Trust (UK)
Hospital/treatment centre

Blackshaw Road
Tooting
London
SW17 0QT
England
United Kingdom

ROR logo "ROR" https://ror.org/039zedc16

Funders

Funder type

Hospital/treatment centre

St George's Heart Science Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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