In this pilot study, aimed at exploring the feasibility of a large-scale trial of low-dose aspirin in polycythaemia vera (PV), 112 PV patients (42 females, 70 males, aged 17–80 years) were selected for not having a clear indication for, or contraindication to, aspirin treatment and randomized to receive oral aspirin (40 mg/d) or placebo. Follow-up duration was 16 ± 6 months. Measurements of thromboxane A2 production during whole blood clotting demonstrated complete inhibition of platelet cyclooxygenase activity in patients receiving aspirin. Aspirin administration was not associated with any bleeding complication. Within the limitations of the small sample size, this study indicates that a biochemically effective regimen of antiplatelet therapy is well tolerated in patients with polycythaemia vera and that a large-scale placebo-controlled trial is feasible.
Steering and Writing Committee: T. Barbui, G. de Gaetano, G. Finazzi, R. Landolfi, R. Marchioli, C. Patrono, G. Tognoni. Safety and Monitoring Board: F. Capani, A. De Carli, D. Gambi, G. G. Nenci. Advisory Board: S. Tura, F. Mandelli, P. Rossi-Ferrini. Principal Investigators: T. Barbui, S. Cortelazzo, G. Finazzi, O. Vestri (Ospedali Riuniti Bergamo, Italy); S. Tura, C. Finelli, F. Nocentini (Università di Bologna, Italy); E. M. Pogliani, I. R. Miccolis (Ospedale S. Gerardo, Monza, Italy); B. Bizzi, R. Landolfi, B. Rocca, R. Tartagilione (Università Cattolica dei Sacro Cuore, Roma, Italy); G. Angeli, A. Di Blasio, A. Di Pasquale, V. Kramer, R. M. Marfisi, M. Olivieri, L. Sciulli, R. Spoltore (Istituto di Ricerche Farmacologiche Mario Negri, Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy); F. Mandelli, E. Montefusco, A. Spadea (Università La Sapienza, Roma, Italy); M. Carotenuto, M. Nobile, A. Morelli (Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Italy); L. Resegotti, M. A. Ciocca Vasino (Ospedale Molinette, Torino, Italy); F. Rodeghiero, M. Ruggeri (Ospedale S. Bartolo, Vicenza, Italy).