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ISRCTN25644448

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

Datenbasis: WHO (Import vom 23.06.2019)
Geändert: 26.05.2019
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Cerebral vein thrombosis
Circulatory System

Interventions (Datenquelle: 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 (Datenquelle: 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)

Weitere Angaben zur Studie im WHO-Primärregister

http://isrctn.com/ISRCTN25644448

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN25644448

Weitere Informationen zur Studie

Registrationsdatum der Studie

10.04.2014

Einschluss der ersten teilnehmenden Person

01.03.2014

Rekrutierungsstatus

Completed

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)

Interventional

Design der Studie (Datenquelle: WHO)

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

Phase (Datenquelle: WHO)

Not Applicable

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)

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

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

Kontakt für weitere Auskünfte zur Studie

Kontakt für wissenschaftliche Auskünfte (Datenquelle: 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

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Institute of Molecular Medicine (Instituto de Medicina Molecular) (Portugal)

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

N/A