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European Collaboration on Low-Dose Aspirin in the Treatment of Polycythemia Vera : A Randomised Placebo-Controlled Trial

Objective

To assess the long-term antithrombotic effect of low-dose aspirin (ASA) on the risk of thrombotic events in Polycythemia Vera (PV);
To assess the benefit/risk profile of low-dose aspirin in PV;
To update the natural history of PV.

Polycythemia Vera (PV) is a rare hematological myeloproliferative disorder. Notwithstanding cytoreductive treatments, thrombosis remains a major cause of morbidity and mortality in PV. Antiplatelet agents have long been considered unsafe in PV patients because of reports of gastrointestinal haemorrhage in patients receiving high aspirin (ASA) doses. ASA, on the other hand, is selectively effective in the treatment of PV vascular disturbances such as erythro-melalgia, transient neurological and ocular disturbances. In addition, asymptomatic PV patients have an enhanced in vivo production of ThromboxaneA2 that can be largely suppressed by chronic administration of low-dose ASA (50 mg daily).
Population: Women and men aged > 50 years with PV whose benefit/risk ratio of ASA therapy is considered uncertain by clinicians in charge of their care.
Experimental design: Eligible patients will be randomized to ASA (40 mg once daily) versus placebo. The randomization will be double blind, centrally co-ordinated, and stratified for each centre according to thrombotic history and duration of the disease. Patients will be followed-up over 3 years.
Observational design: A register of non-randomized patients will be developed and information will be required annually on major vascular and neoplastic events.
Sample size: 2,500 patients followed over 3 years are needed to demonstrate a 30% reduction of thrombotic events.
Organization: In each participating country, a local structure develops and co-ordinates the network of clinical centres which will adhere to the study; the International Co-ordinating Centre in Italy co-ordinates the whole study, receives data forms, and develops a centralised data-base.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Consorzio Mario Negri Sud
Address
Via Nazionale
66030 Santa Maria Imbaro Chieti
Italy

Participants (8)

Hôpital Saint-Louis
France
Address
1,Avenue Claude Vellefaux
75475 Paris
Medizinische Hochschule Hannover
Germany
Address
1,Carl-neuberg-strasse
30625 Hannover
Ospedale Ruiniti Bergamo
Italy
Address
Largo Barozzi 1
24128 Bergamo
Royal Bournemouth Hospital
United Kingdom
Address
Castle Lane East
BH7 7DW Bournemouth
Sahlgren's Hospital
Sweden
Address

413 45 Göteborg
Università Cattolica del Sacro Cuore
Italy
Address
Largo Agostino Gemelli 8
00168 Roma
Università degli Studi Gabriele d'Annunzio
Italy
Address
Via Dei Vestini 31
66013 Chieti
Universität Wien
Austria
Address
18-20,Währinger Gürtel
1090 Wien