In ischaemic stroke, thrombolytic drugs speed the recanalisation of intracerebral arteries. The effects of aspirin are not known. A trial was conducted to determine whether, separately or together, streptokinase and aspirin have clinical benefits in acute ischaemic stroke similar to those in acute myocardial infarction. 622 patients with acute ischaemic stroke within 6 hours of symptom onset were randomised with a 2x2 factorial design to (i) a 1-hour intravenous infusion of 1 . 5 MU streptokinase, (ii) 300 mg/day buffered aspirin for 10 days, (iii) both active treatments, or (iv) neither. Early results raised a question whether the trial should be continued. Streptokinase (alone or with aspirin) was associated with an excess of 10-day case fatality (odds ratio 2 . 7; 95% confidence interval 1 . 7-4 . 3; 2p<0.00001). Of the four groups randomised, only patients allocated to streptokinase plus aspirin had a significantly higher risk of early death than those given neither streptokinase nor aspirin (odds ratio 3 . 5; 95% CI 1 . 9-6 . 5; 2p<0.00001). Streptokinase (alone or with aspirin) and aspirin (alone or with streptokinase) reduced, albeit not significantly, the incidence of combined six-month case fatality and severe disability: odds ratio for streptokinase 0 . 9 (95% CI 0 . 7-1 . 3) and odds ratio for aspirin 0 . 9 (95% CI 0 . 6-1 . 3). The risk of early death with thrombolytic treatments should be weighed against the potential benefit of a marginal reduction of severe disability after the first six months.

RANDOMIZED CONTROLLED TRIAL OF STREPTOKINASE, ASPIRIN, AND COMBINATION OF BOTH IN TREATMENT OF ACUTE ISCHEMIC STROKE

NEGRI E;
1995

Abstract

In ischaemic stroke, thrombolytic drugs speed the recanalisation of intracerebral arteries. The effects of aspirin are not known. A trial was conducted to determine whether, separately or together, streptokinase and aspirin have clinical benefits in acute ischaemic stroke similar to those in acute myocardial infarction. 622 patients with acute ischaemic stroke within 6 hours of symptom onset were randomised with a 2x2 factorial design to (i) a 1-hour intravenous infusion of 1 . 5 MU streptokinase, (ii) 300 mg/day buffered aspirin for 10 days, (iii) both active treatments, or (iv) neither. Early results raised a question whether the trial should be continued. Streptokinase (alone or with aspirin) was associated with an excess of 10-day case fatality (odds ratio 2 . 7; 95% confidence interval 1 . 7-4 . 3; 2p<0.00001). Of the four groups randomised, only patients allocated to streptokinase plus aspirin had a significantly higher risk of early death than those given neither streptokinase nor aspirin (odds ratio 3 . 5; 95% CI 1 . 9-6 . 5; 2p<0.00001). Streptokinase (alone or with aspirin) and aspirin (alone or with streptokinase) reduced, albeit not significantly, the incidence of combined six-month case fatality and severe disability: odds ratio for streptokinase 0 . 9 (95% CI 0 . 7-1 . 3) and odds ratio for aspirin 0 . 9 (95% CI 0 . 6-1 . 3). The risk of early death with thrombolytic treatments should be weighed against the potential benefit of a marginal reduction of severe disability after the first six months.
1995
CANDELISE L; ARITZU E; CICCONE A; RICCI S; WARDLAW J; TOGNONI G; RONCAGLIONI MC; NEGRI E; COLOMBO F; BOCCARDI E; DEGRANDI C; SCIALFA G; ARGENTINO C; BERTELE V; MAGGIONI AP; PERRONE P; BARNETT HJM; BOGOUSSLAVSKY J; DELFAVERO A; LOI U; PETO R; WARLOW C; CANZI S; COMPARETTI S; CLERICI F; PALUMBO A; SGARONI G; POLONARA S; REGINELLI R; CERAVOLO MG; PROVINCIALI L; DELGOBBO M; SCARPINO O; BOTTACCHI E; DALESSANDRO G; DIGIOVANNI M; BLANC S; ROVEYAZ L; RALLI L; VANNI D; REFI C; FEDERICO F; CONTE C; INCHINGOLO V; INSABATO R; SALSA F; LORIZIO A; ROTTOLI MR; BRUNI L; DEFANTI CA; FERA L; CAMERLINGO M; CASTO L; CENSORI B; MAMOLI A; PORAZZI D; GRAMPA G; LASPINA I; GIGLIA L; AVENIA V; GUELI S; LOLLI V; MIELE V; SANTANGELO M; COPPOLA G; TRIANNI G; MARRA M; GRECO E; TONTI D; PRETOLANI E; STELLIO M; ARNABOLDI M; CIOLA R; DANIELI G; REZZONICO M; GUIDOTTI M; PELLEGRINI G; RAUDINO F; DELFAVERO C; FRATTINI T; RICCARDI T; LEVIMINZI C; LOCATELLI F; PASSERI F; LOMBARDO G; COCCO F; PRATESI M; SANTINI S; CARDOPATRI F; TAFANI O; LANDINI GC; PIERAGNOLI E; BELLESI R; BAGNOLI L; GHETTI A; MARRAZZA OB; MENEGAZZO P; SPOLVERI S; CAPPELLETTI C; CANDELIERE G; COSTANTINO G; DACUNO F; LOMUZIO T; RIZZITELLI FP; BOVIO G; GRILLI GP; ZOCCHI M; MAZZANTI I; PISAPIA G; NUZZI R; RUSSO G; LAMA G; BALDASSARRI G; BETTINI R; CANI E; CERIOLI E; DEGIORGI M; GARAGNANI A; PASQUALI S; CHIOMA V; FINI C; MARZARA G; BALOTTA A; BERTUZZI D; MASINA M; MATACENA C; MICHELINI M; PIRAZZOLI G; SACCHET C; MAROTTA P; CALVI L; SCACCABAROZZI C; MENOZZI C; SASANELLI F; BASCELLI C; PONTRELLI V; SCHIERONI F; BELVEDERE D; DECAPITANI E; DICOSTANZO M; RASCAROLI M; CITTERIO O; MILANI R; CAPIALBI R; ARENA G; MUSOLINO R; DIPERRI R; BONAVENTI C; FINZI F; MESSINA A; ROMANAZZI V; STERZI R; BOTTINI G; SANTILLI I; BRUCATO A; DEJULI E; PALMIERI G; RAGAINI S; THIELLA G; ALLI C; CAROSELLA L; RIZZATO G; CANDELISE L; ARITZU E; BIANCHI M; CICCONE A; MOTTO C; PINARDI G; SCARLATO G; BETTINELLI A; PORRO F; RANDAZZO A; MARINI U; LATTUADA P; PIETRA A; FRANCESCHI M; VOLOUTE MA; MALFERRARI G; BONDI M; GARUTI W; MELINI L; COLOMBO A; ALBORINI G; PANZETTI P; SCARPA M; SORGATO P; CRISI G; BONASERA N; BASSO F; NATALI E; MONACO P; GASPARRO AM; TRIOLO F; LECHI A; COLONNA F; DASCOLA I; GIORGI C; SCODITTI U; BASSI P; MENOZZI R; PIAZZA P; DEGLIANTONI G; DESIMONI M; GIANNINI A; MICILI G; BOSONE D; CAVALLINI A; MARTELLI A; BARZIZZA F; POLI M; RICCI S; BIAGINI S; CAPOCCHI G; CELANI MG; PICCHIARELLI A; RIGHETTI E; ZAMPOLINI M; CAPUTO N; BARTOLINI S; SANTONI M; SITA D; TAGLIOLI M; VOLPI G; ROSSI F; ALOY F; CASTELLANO AE; MINOTTA F; GATTA A; VINATTIERI A; CANTINI A; REBUCCI GG; BISSI G; DEBLASI F; PASCARELLI E; TURIAMO F; GUIDETTI D; BARATTI M; FERRARINI G; GHIDONI E; GRECO G; MARCELLO N; MOTTI L; SOLIME F; TERENZIANI S; ZUCCO R; TROISO A; VENEZIANI M; IORI I; CURATOLA L; BOLLETTINI G; CARBONI T; GOBBATO R; INFRICCIOLO P; SABATINI D; SFRAPPINI M; FANCELLU A; CASU G; DELEDDA MG; SPANU MA; PIRISI A; MARRAS FA; ROSATI G; BRAMBILLA A; ERLI GC; FELICE B; GRANDI R; MIRABILE D; ZADRA M; CAVESTRI R; GORI D; LONGHINI E; MIELE N; DIVIZIA G; GRASSELLI S; PEZZELLA F; ZUCCARI F; SALLUSTO L; LINCESSO F; SCARPATI C; IANNONE G; BARTOCCI A; COSTANTINI F; DESANTIS L; LANCIA G; MOSCHINI E; PACI A; SENSIDONI A; TRENTA A; BARTOLINI N; OTTAVIANO P; BISCOTTINI B; ALUNNI G; BARTOLINI I; BELLADONNA D; BOCCALI A; CRUCIANI M; IBBA R; LUCCIOLI R; MARCECA A; PACINI M; PALLONE M; GIRARDI P; ORRICO D; LANZA E; BALLINI A; GRANDI FC; MUSCO G; STEIDL L; SANTORO G; VEMCO A; DUDINE P; MILONE FF; MUNARI L; PERRETI A; PORTA M; LONGONI C; FERANI R; WATT M; SANDERCOCK P; FENNETRY A; BANNISTER P; CLARKE CE; BAMFORD J; VENABLES G; CORREIA M
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/866752
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? 493
social impact