Prevention of cardiovascular events in Asian patients with ischaemic stroke at high risk of cerebral haemorrhage (PICASSO): a multicentre, randomised controlled trial

Lancet Neurology
Bum Joon KimPICASSO Investigators

Abstract

The optimal treatment for patients with ischaemic stroke with a high risk of cerebral haemorrhage is unclear. We assessed the efficacy and safety of cilostazol versus aspirin, with and without probucol, in these patients. In this randomised, controlled, 2 × 2 factorial trial, we enrolled patients with ischaemic stroke with a history of or imaging findings of intracerebral haemorrhage or two or more microbleeds from 67 centres in three Asian countries. Patients were randomly assigned (1:1:1:1) to receive oral cilostazol (100 mg twice a day), aspirin (100 mg once a day), cilostazol plus probucol (250 mg twice a day), or aspirin plus probucol with centralised blocks stratified by centre. Cilostazol versus aspirin was investigated double-blinded; probucol treatment was open-label, but the outcome assessor was masked to assignment. The co-primary outcomes were incidence of the composite of stroke, myocardial infarction, or vascular death (efficacy) and incidence of haemorrhagic stroke (safety), which were assessed in intention-to-treat and modified intention-to-treat populations. Efficacy was analysed with a non-inferiority test and a superiority test if non-inferiority was satisfied. Safety was assessed with a superiority test only...Continue Reading

Citations

Jan 24, 2019·Journal of Neurology·Hyuk Sung KwonUNKNOWN PICASSO investigators
Jan 15, 2019·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·J-H ParkUNKNOWN PICASSO investigators
May 8, 2019·European Journal of Preventive Cardiology·Cesare R SirtoriMassimiliano Ruscica
Dec 17, 2018·Journal of Neurology, Neurosurgery, and Psychiatry·Yannie SooUNKNOWN IPAAC study group
Dec 24, 2019·Hypertension·Matthew TraylorHugh S Markus
Apr 1, 2020·Expert Opinion on Drug Metabolism & Toxicology·Brian TomlinsonChristopher Wai Kei Lam
Jul 11, 2020·Stroke; a Journal of Cerebral Circulation·Caroline McHutchisonJoanna M Wardlaw
Jul 16, 2020·International Journal of Stroke : Official Journal of the International Stroke Society·Hong-Kyun ParkUNKNOWN PICASSO investigators
Nov 14, 2019·Journal of Neurology·Hyuk Sung KwonUNKNOWN PICASSO investigators
Nov 23, 2019·Stroke; a Journal of Cerebral Circulation·Eric E Smith, Hugh S Markus
Dec 21, 2019·Stroke; a Journal of Cerebral Circulation·Bum Joon KimUNKNOWN PICASSO Investigators
Jun 12, 2018·Journal of Stroke·Georgios TsivgoulisAndrei V Alexandrov
Nov 23, 2019·Stroke; a Journal of Cerebral Circulation·Marco Pasi, Charlotte Cordonnier
Jun 12, 2018·Journal of Stroke·Hsin-Hsi TsaiM Edip Gurol
Oct 15, 2019·Stroke; a Journal of Cerebral Circulation·Seung Min KimSun U Kwon
Aug 11, 2020·Expert Opinion on Pharmacotherapy·Brian TomlinsonChristopher Wai Kei Lam
Oct 9, 2020·Journal of Atherosclerosis and Thrombosis·Takeshi OkadaShizuya Yamashita
Jan 4, 2021·Journal of Stroke and Cerebrovascular Diseases : the Official Journal of National Stroke Association·Michelle P LinThomas G Brott
Feb 6, 2021·Stroke and Vascular Neurology·Choon Han TanBenjamin Yq Tan
Apr 17, 2021·Cardiovascular Drugs and Therapy·Riyad Y KherallahYochai Birnbaum
Jul 23, 2021·Stroke and Vascular Neurology·Shina KimHee-Joon Bae
Sep 15, 2021·Stroke; a Journal of Cerebral Circulation·Adam de HavenonMaarten G Lansberg
Nov 17, 2021·Stroke; a Journal of Cerebral Circulation·Byeong C KimSeong Hye Choi
Dec 10, 2021·International Journal of Stroke : Official Journal of the International Stroke Society·Hugh S Markus

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