Condition category
Circulatory System
Date applied
22/09/2004
Date assigned
22/09/2004
Last edited
13/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unipr.it/

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 dell’Università 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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes