Registrationsdatum der Studie
Einschluss der ersten teilnehmenden Person
Wissenschaftlicher Titel (Datenquelle: WHO)
A multicentre, multinational study with a randomised cluster allocation design comparing the efficacy and safety of short (3-6 months) versus long-term (12 months) oral anticoagulation for the prevention of venous thromboembolic events after an episode of cerebral vein thrombosis
Studientyp (Datenquelle: WHO)
Design der Studie (Datenquelle: WHO)
Multicentre multinational prospective study with a cluster allocation design for the therapeutic approach (Treatment)
Phase (Datenquelle: WHO)
Primäre Endpunkte (Datenquelle: WHO)
Any confirmed fatal or nonfatal venous thromboembolic event. The primary outcomes will be measured at 6, 12 and 24 months.These are the compulsory timepoints. However, we also suggest a phone interview at 18 months.
Sekundäre Endpunkte (Datenquelle: WHO)
1. Recurrent CVT: any new neurological symptom with a new thrombus or occlusion (partial or total) of a cerebral vein or dural sinus and confirmed by repeated conventional CT venography, MRI combined with MR venogram, conventional angiography or surgery, following established diagnostic criteria.
2. Deep vein thrombosis (lower or upper limbs, pelvic or abdominal): acute, symptomatic proximal deep-vein thrombosis of the legs, arms or of any abdominal vein, objectively verified with the use of compression ultrasonography or venography of leg veins or arm veins, CT angiography/venography, MRI combined with angiography/venogram, conventional angiography or at surgery.
3. Pulmonary embolism: acute, symptomatic pulmonary embolism objectively verified with the use of ventilation-perfusion
lung scanning, angiography or spiral computed tomography of pulmonary arteries.
4. Arterial thrombotic event (stroke, acute MI, acute arterial limb ischaemia, death proven to be secondary to an arterial vascular event)
5. All thrombotic events (arterial and venous)
6. Death proven to be secondary to a vascular event (arterial or venous), sudden unexplained death (<24 h), nonvascular and death of unknown aetiology
The secondary outcomes will be measured at 6, 12 and 24 months.These are the compulsory timepoints. However, we also suggest a phone interview at 18 months.
Kontakt für Auskünfte (Datenquelle: WHO)
AstraZeneca Foundation (USA), Faculty of Medicine, University of Lisbon (Portugal), Hospital de Santa Maria - North of Lisbon Medical Centre (Portugal)