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

LOWering the INtensity of oral anticoaGulant Therapy in patients with mechanical aortic valve replacement: the ?LOWING-IT? Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34082835

Enrollment

420

Registered

2008-06-19

Start date

2001-01-01

Completion date

Unknown

Last updated

2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant therapy Haematological Disorders Other coagulation defects

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 r

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026