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21 May 2012
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| Lowering the intensity of anticoagulation is safe and effective for patients with mechanical cardiac valve prosthesis |
| ISRCTN | ISRCTN34082835 |
| ClinicalTrials.gov identifier | |
| Public title | Lowering the intensity of anticoagulation is safe and effective for patients with mechanical cardiac valve prosthesis |
| Scientific title | LOWering the INtensity of oral anticoaGulant Therapy in patients with mechanical aortic valve replacement: the “LOWING-IT” Trial |
| Acronym | LOWING-IT |
| Serial number at source | N/A |
| Study hypothesis | The present randomised study tested the hypothesis that a low intensity level oral anticoagulant regime with an international normalised ratio (INR) range between 1.5 to 2.5 is as effective and safe as a higher level of anticoagulant therapy with a recommended INR range of 2.0 to 3.0, in patients with a single aortic mechanical prosthetic valve replacement. In particular, the hypothesised outcome from using a 1.5 to 2.5 INR intensity level (as opposed to the currently recommended INR of 2.0 to 3.0) was a reduction in the incidence of haemorrhagic episodes without affecting the risk of thromboembolic events. |
| Lay summary | |
| Ethics approval | The Ethics Committee of the Postgraduate School of Pathophysiology of the Cardiorespiratory System and Associated Biotechnologies, Second University of Naples granted the initial ethics approval for this trial in December 2000. However, our internal regulations have changed to be in line with the international guidelines since the time of initial approval, and this trial was re-submitted and then re-approved by the Ethics Committee of the Monaldi Hospital, Naples on 23/06/2008 (ref: #15) |
| Study design | Single-centre, randomised controlled trial |
| Countries of recruitment | Italy |
| Disease/condition/study domain | Anticoagulant therapy |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/01/2001 |
| Anticipated end date | 01/01/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 420 |
| Interventions |
The participants were enrolled from January 2001 to January 2005. They were allocated to the following two arms:
Intervention arm: Low intensity oral anticoagulant regime with an INR range between 1.5 to 2.5 Control arm: Higher level of anticoagulant therapy with a recommended INR range of 2.0 to 3.0 The follow-up of the interventions was 4.3 ± 0.9 years. |
| Primary outcome measure(s) |
Thromboembolic and haemorrhagic events, followed-up for 4.3 ± 0.9 years:
1. Cerebral infarction 2. Coronary and/or peripheral embolism 3. Valve thrombosis 4. Intracranial and spinal bleeding 5. Major extra-cranial bleeding 6. Endocarditis 7. Withdrawal from the oral anticoagulant therapy 8. Death Cerebral thromboembolic events included the onset of a transient or definitive symptomatic neurological stroke and/or evidence of an ischaemic vascular brain sequela on a computerised tomography (CT) brain scan. Coronary or peripheral embolic events were documented by echo Doppler, angiography, or surgery. Prosthesis thrombosis was defined as impairment of the valve by the deposition of thrombus, demonstrated by echo Doppler or surgery. Haemorrhagic events were considered to be major when blood transfusion, hospitalisation, or a surgical procedure was required. Other haemorrhages were considered to be non-major but were recorded. |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Funded by the PhD Programme in Cardiologic Sciences, Postgraduate School of Medical Surgical Pathophysiology of the Cardiorespiratory System and Associated Biotechnologies, Second University of Naples, Naples (Italy) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20598989 |
| Contact name | Dr Michele Torella |
| Address |
Department of Cardio-Thoracic and Respiratory Sciences
Second University of Naples Monaldi Hospital Via Leonardo Bianchi, 41 |
| City/town | Naples |
| Zip/Postcode | 80060 |
| Country | Italy |
| Tel | +39 (0)81 706 25 20 |
| Fax | +39 (0)81 546 45 94 |
| michele.torella@unina2.it | |
| Sponsor | Second University of Naples (Seconda Università degli studi di Napoli) (Italy) |
| Address |
Department of Cardio-Thoracic and Respiratory Sciences
Monaldi Hospital Via Leonardo Bianchi, 41 |
| City/town | Naples |
| Zip/Postcode | 80060 |
| Country | Italy |
| Tel | +39 (0)81 7701593 |
| Fax | +39 (0)81 5464594 |
| Maurizio.COTRUFO@unina2.it | |
| Sponsor website: | http://web.unina2.it |
| Date applied | 23/05/2008 |
| Last edited | 18/08/2010 |
| Date ISRCTN assigned | 19/06/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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