Comparing Warfarin to Aspirin after tissue valve replacement with Epic prosthesis in the aortic position: multicenter randomised trial
| ISRCTN | ISRCTN99307171 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99307171 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/09/2004
- Registration date
- 22/09/2004
- Last edited
- 13/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrea Colli
Scientific
Scientific
Via Gramsci 13
Parma
43100
Italy
| Phone | +39 349 5928935 |
|---|---|
| colli.andrea@libero.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | WoA Epic |
| Study objectives | Patients with prosthetic heart valves have a higher risk of developing valve thrombosis and arterial thromboembolism. However, antithrombotic therapy in the early postoperative period after Biological Aortic Valve Replacement (BAVR) is still controversial. Many regimens have been described. Thus, the aim of this study will be to compare the validity of two different regimens of therapy in the early postoperative period after BAVR with St Jude Epic prosthesis, and to evaluate the benefits, particularly in terms of survival and cerebral protection from thromboembolism and major bleeding. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Biological Aortic Valve Replacement |
| Intervention | Patients will receive a specific regimen of therapy according to the result of randomisation. The administration of Low Molecular Weight Heparin (LMWH) will start on the first postoperative day, whereas warfarin and ASA on day 2. In patients receiving warfarin the use of LMWH will be continued until warfarin reached therapeutic levels as shown by a Prothrombin Time (PT) according to the International Normalised Ratio (INR; range 2.0 to 3.0). Anticoagulation with warfarin will be maintained for 3 postoperative months, then will be discontinued and substituted with ASA. Those with concomitant coronary artery bypass grafting will not receive any double therapy warfarin plus ASA. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Warfarin and aspirin (Acetylsalicylic Acid [ASA]) |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2001 |
| Completion date | 01/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | This is a prospective randomised multicenter trial using patients who will be consecutively admitted to Cardiac Surgery Units. All patients undergoing Biological Aortic Valve Replacement (BAVR) with a St Jude Epic prosthesis and in sinus rhythm before the operation will be considered to participate to the study. The patients, after the operation, will be randomised to each group immediately before starting the specific aspirin (Acetylsalicylic Acid [ASA]) or warfarin therapy. |
| Key exclusion criteria | The patients with the following characteristics will be excluded: 1. History of cerebral ischaemia 2. Coagulopathy 3. Carotid atherosclerotic disease (stenosis greater than 50%, soft and ulcerated plaque) 4. Peripheral vascular disease 5. Concomitant mitral valve disease 6. Double valve replacement 7. Previous chronic anticoagulation therapy 8. Allergies to ASA or warfarin 9. Comparison of atrial fibrillation (AF) at any time during the study except for transient episode during the hospitalisation 10. Promptly cardioverted |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/12/2002 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Gramsci 13
Parma
43100
Italy
43100
Italy
Sponsor information
University of Parma (Italy)
University/education
University/education
Cardiac Surgery Unit
Via Gramsci 13
Parma
43100
Italy
| Phone | +39 349 5928935 |
|---|---|
| colli.andrea@libero.it | |
| Website | http://www.unipr.it/ |
"ROR" |
https://ror.org/02k7wn190 |
Funders
Funder type
Other
Company of Saint Paul (Compagnia di S Paolo) (Italy)
No information available
Ministry for Universities and of Scientific and Technological Research (Ministero dellUniversità e della Ricerca Scientifica e Tecnologica [MURST]) (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | PubMed Abstract: | 03/08/2004 | No | No | |
| Other publications | Full text: | 03/08/2004 | Yes | No |
