The benefit of EXtending oral antiCOAgulation treatment (EXCOA) after acute cerebral vein thrombosis (CVT): EXCOA-CVT cluster randomized trial protocol

International Journal of Stroke : Official Journal of the International Stroke Society
Bruno MirandaJosé M Ferro

Abstract

Rationale After a cerebral vein thrombosis, there is an increased risk of further venous thromboembolic events. The optimal duration of anticoagulation after cerebral vein thrombosis is unknown. Aim To compare efficacy and safety of a policy of short- (3-6 months) versus long-term (12 months) anticoagulation (any type venous thromboembolic events) after cerebral vein thrombosis for the prevention of venous thromboembolic events. Sample size estimates A sample of 1428 patients (749 per arm) allows detecting a reduction from 10 to 5% in the risk of venous thromboembolic event recurrence with 80% power at 5% significance, with 3% dropout rate. Methods and design An international multicenter, prospective cluster-randomized trial with equal allocation between both interventions (ISRCTN25644448). Each cluster is a participating center, which accepted to be randomly allocated to one of the anticoagulation policies. Eligible patients are adults with radiologically confirmed cerebral vein thrombosis within 30 days, and stable to initiate post-acute anticoagulation. Patients judged by the investigator to be an absolute indication for permanent anticoagulation are excluded. Follow-up is at 6, 12 and 24 months. Study outcomes Primary effic...Continue Reading

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Citations

Jun 21, 2018·Journal of Thrombosis and Haemostasis : JTH·M CapecchiI Martinelli
May 17, 2019·Stroke; a Journal of Cerebral Circulation·Thalia S Field, Michael D Hill
Mar 20, 2020·JAMA Ophthalmology·Christopher P LongCatherine Y Liu
Mar 14, 2020·Journal of Clinical Medicine·Nicoletta Riva, Walter Ageno
Jul 17, 2020·Journal of Family Medicine and Primary Care·Subhankar ChatterjeeCarl J Lavie
Jan 10, 2020·Blood·Maria AbbattistaIda Martinelli
Sep 23, 2020·Practical Neurology·Leonardo UliviDavid J Werring
Sep 24, 2019·Saudi Journal of Medicine & Medical Sciences·Abdulla Al-Sulaiman
Feb 16, 2021·Hämostaseologie·Diana Aguiar de Sousa
Mar 23, 2021·Therapeutic Advances in Neurological Disorders·Büșra DurmușSusanna M Zuurbier
Mar 17, 2021·International Journal of Stroke : Official Journal of the International Stroke Society·José M FerroUNKNOWN RE-SPECT CVT Study Group
Apr 10, 2021·Curēus·Amandeep RakhraRammohan Sankaraneni
Dec 11, 2021·Hematology·Carol Mathew, Marc Zumberg
Jan 15, 2022·Current Cardiology Reports·Arshia AlimohammadiThalia S Field

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ISRCTN25644448

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