Contact information
Type
Scientific
Primary contact
Dr Andrea Colli
ORCID ID
Contact details
Via Gramsci 13
Parma
43100
Italy
+39 349 5928935
colli.andrea@libero.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
WoA Epic
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/01/2001
Overall trial end date
01/12/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/01/2001
Recruitment end date
01/12/2002
Locations
Countries of recruitment
Italy
Trial participating centre
Via Gramsci 13
Parma
43100
Italy
Sponsor information
Organisation
University of Parma (Italy)
Sponsor details
Cardiac Surgery Unit
Via Gramsci 13
Parma
43100
Italy
+39 349 5928935
colli.andrea@libero.it
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Company of Saint Paul (Compagnia di S Paolo) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry for Universities and of Scientific and Technological Research (Ministero dellUniversità e della Ricerca Scientifica e Tecnologica [MURST]) (Italy)
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
PubMed Abstract: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15289387
Full text: http://circ.ahajournals.org/cgi/content/full/110/5/496
Publication citations
-
PubMed Abstract
Gherli T, Colli A, Fragnito C, Nicolini F, Borrello B, Saccani S, D'Amico R, Beghi C, Comparing warfarin with aspirin after biological aortic valve replacement: a prospective study., Circulation, 2004, 110, 5, 496-500, doi: 10.1161/01.CIR.000013712295108.52.