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ISRCTN25644448

EXCOA-CVT study: the benefit of EXtending oral antiCOAgulation treatment after acute Cerebral Vein Thrombosis

Base di dati: WHO (Importata da 03.05.2024)
Cambiato: 4 apr 2021, 01:00
Categoria di malattie:

Health conditions (Fonte di dati: WHO)

Cerebral vein thrombosis
Circulatory System

Interventions (Fonte di dati: WHO)

Before the study starts, each of the participating centres will be asked whether they have a preference for any of the policy treatment options. If so, they will follow their preferred policy. Centres with no preference will be given the alternative to adopt one of the policies or to be randomly allocated to one of the policy treatment options. Patients will follow a treatment of short-term (3-6 months) or long-term (12 months) oral anticoagulation according to the approach initially allocated to their centre, as soon as their acute clinical situation is stable and not more than 1 month after the CVT diagnosis. The total follow-up time will be 24 months.

Inclusion/Exclusion Criteria (Fonte di dati: WHO)

Inclusion criteria:
1. Patients with acute symptomatic and radiologically confirmed cerebral vein thrombosis (CVT)
2. Age = 18 years at entry
3. CVT must have been diagnosed in <1 month before inclusion
4. The patient must be clinically stable and able to stop parenteral anticoagulation in order to initiate oral anticoagulation
5. Written informed consent

Exclusion criteria:
1. Systemic life-threatening or major bleeding while on anticoagulants during the acute phase of CVT or during the 6 months prior to randomisation (intracranial bleeding due to inclusion CVT is not an exclusion criteria)
2. General contraindications for anticoagulant therapy
3. Need for prolonged treatment with antiplatelet drugs, non-steroidal anti-inflammatory drugs or other drugs/diseases that interfere significantly with anticoagulant therapy or with INR
4. Life expectancy < 2 years due to a pre-existing condition (including any malignancy)
5. Childbearing potential without adequate contraceptive measures, pregnancy or breastfeeding
6. Known allergy to study medications
7. Other conditions judged by the investigator to be an absolute indication for prolonged oral anticoagulation such as recurrent CVT, venous thromboembolism (VTE) after CVT or first CVT with antiphospholipid syndrome or known severe thrombophilia (antithrombin, protein C or protein S deficiency, homozygous factor V Leiden or prothrombin G20210A mutation or combined abnormalities)

Altri dati sulla sperimentazione nel registro primario dell’OMS

http://isrctn.com/ISRCTN25644448

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN25644448
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

10 apr 2014

Inserimento del primo partecipante

1 mar 2014

Stato di reclutamento

Ongoing

Titolo scientifico (Fonte di dati: 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

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Multicentre multinational prospective study with a cluster allocation design for the therapeutic approach (Treatment)

Fase (Fonte di dati: WHO)

Not Applicable

Punti finali primari (Fonte di dati: 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.

Punti finali secondari (Fonte di dati: 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.

Contatto per informazioni (Fonte di dati: WHO)

AstraZeneca Foundation (USA), Faculty of Medicine, University of Lisbon (Portugal), Hospital de Santa Maria - North of Lisbon Medical Centre (Portugal)

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29771211 (added 24/04/2019)

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

Not provided at time of registration
Not provided at time of registration

Siti di esecuzione della sperimentazione

Paesi di esecuzione (Fonte di dati: WHO)

Austria, Belgium, Brazil, Denmark, Finland, France, Germany, Greece, India, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom

Contatto per maggiori informazioni sulla sperimentazione

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Jose
Ferro
Unidade Neurológica de Investigação Clínica do Instituto de Medicina Molecular Faculdade de Medicina ? Universidade de Lisboa Av. Prof. Egas Moniz
-
jmferro@medicina.ulisboa.pt

Altri numeri di identificazione delle sperimentazioni

Secondary ID (Fonte di dati: WHO)

N/A
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