owering the intensity of anticoagulation is safe and effective for patients with mechanical cardiac valve prosthesis

Not Applicable

Completed

• Conditions: Anticoagulant therapy; Haematological Disorders; Other coagulation defects

• Registration Number: ISRCTN34082835
• Lead Sponsor: Second University of Naples (Seconda Università degli studi di Napoli) (Italy)

Brief Summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20598989 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29849105 (added 14/10/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-01-01
• Study Start: 2008-06-19
• Last Update Posted: 4 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 292

Inclusion Criteria

1. Both male and female patients, aged 20 - 60 years
2. Those presenting for a first single-valve replacement with a bileaflet mechanical prosthesis in the aortic position
3. Those with a low thrombo-embolic risk
4. Valve prosthesis dimension greater than 21 mm
5. Normal ejection fraction (EF)
6. Left atrium diameter less than 47 mm
7. Normal sinus rhythm

Exclusion Criteria

1. Contraindication to anticoagulant treatment (including pregnant women)
2. Valvular prosthesis on another orifice
3. Dialysed renal failure
4. Hepatic insufficiency
5. Patient or general practitioner refusal to participate in the study
6. Patients with a high risk of thromboembolic events (i.e. atrial fibrillation, history of cardiac thromboembolism, left atrial diameter greater than 47 mm on a time-motion echocardiogram, thrombosis or calcification of the left atrium) (exclusion for ethical reasons)

Study & Design

• Study Type: Interventional
• Study Design: Not specified