Lowering the intensity of anticoagulation is safe and effective for patients with mechanical cardiac valve prosthesis
ISRCTN | ISRCTN34082835 |
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DOI | https://doi.org/10.1186/ISRCTN34082835 |
Secondary identifying numbers | N/A |
- Submission date
- 23/05/2008
- Registration date
- 19/06/2008
- Last edited
- 14/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michele Torella
Scientific
Scientific
Department of Cardio-Thoracic and Respiratory Sciences
Second University of Naples
Monaldi Hospital
Via Leonardo Bianchi, 41
Naples
80060
Italy
Phone | +39 (0)81 706 25 20 |
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michele.torella@unina2.it |
Study information
Study design | Single-centre, randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | LOWering the INtensity of oral anticoaGulant Therapy in patients with mechanical aortic valve replacement: the LOWING-IT Trial |
Study acronym | LOWING-IT |
Study objectives | 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. |
Ethics approval(s) | 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) |
Health condition(s) or problem(s) studied | Anticoagulant therapy |
Intervention | 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. |
Intervention type | Other |
Primary outcome measure | 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 measures | No secondary outcome measures |
Overall study start date | 01/01/2001 |
Completion date | 01/01/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 420 |
Total final enrolment | 292 |
Key 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 |
Key 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) |
Date of first enrolment | 01/01/2001 |
Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Cardio-Thoracic and Respiratory Sciences
Naples
80060
Italy
80060
Italy
Sponsor information
Second University of Naples (Seconda Università degli studi di Napoli) (Italy)
University/education
University/education
Department of Cardio-Thoracic and Respiratory Sciences
Monaldi Hospital
Via Leonardo Bianchi, 41
Naples
80060
Italy
Phone | +39 (0)81 7701593 |
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Maurizio.COTRUFO@unina2.it | |
Website | http://web.unina2.it |
https://ror.org/05290cv24 |
Funders
Funder type
University/education
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)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/07/2010 | Yes | No | |
Results article | results | 30/05/2018 | 14/10/2019 | Yes | No |
Editorial Notes
14/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.