The MATCH Steering Committee - ACETYLSALICYLIC ACID (ASA) PROVIDES NO ADDITIONAL CLINICAL BENEFIT IN HIGH RISK PATIENTS

The MATCH Steering Committee - ACETYLSALICYLIC ACID (ASA) PROVIDES NO ADDITIONAL CLINICAL BENEFIT IN HIGH RISK PATIENTS WITH STROKE OR TIA WHEN ADDED TO CLOPIDOGREL AND OTHER STANDARD THERAPIES Mannheim, Germany May 13, 2004 - Results of the MATCH trial (Management of ATherothrombosis with Clopidogrel in High Risk Patients with recent transient ischemic attack (TIA) or ischemic stroke (IS)) announced today at the 13th European Stroke conference in Mannheim-Heidelberg, Germany, show that acetylsalicylic acid (ASA) when added to clopidogrel and other standard prevention therapies in high-risk cerebrovascular patients does not result in an improved benefit-to-risk ratio compared to placebo. "The MATCH trial shows that in a high risk population of cerebrovascular patients with several additional risk factors, adding ASA to clopidogrel background therapy shows a non-significant trend versus adding placebo in reducing further ischaemic events but leads to more life-threatening bleedings," said Prof. Dr. Hans-Christoph Diener MD, PhD, FAHA, Department of Neurology, Universität Essen, Germany and principal investigator of the MATCH trial. The MATCH trial compared ASA to placebo on top of clopidogrel background therapy in both arms, in the prevention of further ischaemic events (ischaemic stroke, myocardial infarction [MI], vascular death, or rehospitalisation for ischaemic events) in high-risk patients with a recent TIA or IS and previous ischaemic events or diabetes. With 7,599 patients enrolled across 507 centres in 28 countries, MATCH is the largest study conducted to date in such a high-risk population of cerebrovascular patients. The mean age at randomisation was 66 years and 63% of the study population was male. In addition to having experienced a previous ischaemic stroke (78.9% of patients) or transient ischaemic attack (21.1%), patients suffered from multiple additional vascular risk factors: e.g. 78.2% were hypertensive, 68.4% had diabetes mellitus and 56.4% had hypercholesterolaemia. The study results showed that the addition of ASA had only a limited, statistically non-significant effect on ischemic events in this patient population. 596 (15.70%) on ASA had a further ischaemic event versus 636 patients (16.73%) on placebo (relative risk reduction = 6.4%; p=0.244). This trend was consistent among all components of the primary efficacy endpoint. In addition, the study findings showed that ASA leads to more significant, life-threatening bleedings compared to placebo in patients receiving clopidogrel and other standard therapies (96 patients (2.6%) on ASA versus 49 patients (1.3%) on placebo). "The landmark CAPRIE study showed clopidogrel to be superior to and better tolerated than ASA in preventing recurrent stroke, MI, and vascular death in a broad atherothrombotic population, including cerebrovascular patients. In CAPRIE, this superiority was amplified in patients at higher risk of such events, such as those who had had a previous ischaemic stroke or TIA, the population studied in the MATCH trial." said Lawrence M. Brass M.D., Professor of Neurology, Yale University School of Medicine, New Haven Connecticut and a member of the steering committee of the MATCH trial. "If we consider all the clinical data we now have available on the use of clopidogrel in a high-risk cerebrovascular population, we can conclude that clopidogrel appears to be the appropriate standard therapy for secondary prevention of stroke, MI and vascular death in stroke patients" said Donald Easton, M.D., Professor and Chairman, Department of Neurology, Rhode Island Hospital - Brown Medical School and member of the Data Safety Monitoring Board (DSMB) of the MATCH trial. "This is of primary importance for clinicians treating patients who fall into this category," he added. Despite medical progress in recent years, stroke remains the third leading cause of mortality (after MI and cancer), the second leading cause of vascular dementia, and the major cause of permanent disability in the western world today. Ischemic stroke and transient ischemic attacks are cerebrovascular manifestations of atherothrombosis. Professor Hans-Christoph Diener is the Chair of the MATCH Steering Committee, and also the International Coordinating Investigator. The MATCH trial was sponsored by Sanofi-Synthelabo Research and co-funded in the United States by Sanofi-Synthelabo and Bristol-Myers Squibb. Contact information: Nicci Parry: + 44 7961 187 699 In the U.S.: Tom Vickery: + 1 212 593 6307 ------------------------------------------------------------ Ytterligere informasjon kan hentes på følgende hjemmeside: http://www.waymaker.no Nedenstående filer kan lastes ned: http://www.waymaker.net/bitonline/2004/05/13/20040513BIT20240/wkr0008.doc Pressemeldingen på fransk