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

Via Gramsci 13
Parma
43100
Italy

Phone +39 349 5928935
Email colli.andrea@libero.it

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymWoA Epic
Study objectivesPatients 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) studiedBiological Aortic Valve Replacement
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Warfarin and aspirin (Acetylsalicylic Acid [ASA])
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2001
Completion date01/12/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaThis 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 criteriaThe 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 enrolment01/01/2001
Date of final enrolment01/12/2002

Locations

Countries of recruitment

  • Italy

Study participating centre

Via Gramsci 13
Parma
43100
Italy

Sponsor information

University of Parma (Italy)
University/education

Cardiac Surgery Unit
Via Gramsci 13
Parma
43100
Italy

Phone +39 349 5928935
Email colli.andrea@libero.it
Website http://www.unipr.it/
ROR logo "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 dell’Università e della Ricerca Scientifica e Tecnologica [MURST]) (Italy)

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

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