Anticoagulation following tissue aortic valve replacement
| ISRCTN | ISRCTN51663857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51663857 |
| Protocol serial number | 06/Q0803/36 |
| Sponsor | St George's Healthcare NHS Trust (UK) |
| Funder | St George's Heart Science Fund |
- 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
Scientific
St George's Healthcare NHS Trust
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Anticoagulation following tissue aortic valve replacement |
| Study acronym | AFTAV |
| Study objectives | Null 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) studied | Aortic valve disease |
| Intervention | Three groups: warfarin therapy for 90 days, aspirin therapy for 90 days, control group (no medication) |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Neurological events |
| Key secondary outcome measure(s) |
Thrombus formation |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | Patients undergoing tissue aortic valve replacement |
| Key exclusion criteria | 1. Patients who require aspirin or warfarin therapy on established medical grounds 2. Patients unable to take warfarin or aspirin |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St George's Healthcare NHS Trust
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/10/2016: No publications found in PubMed, verifying study status with principal investigator.
