Boehringer Ingelheim

Prehospital Thrombolysis for AMI to be Studied in New Clinical Trial
Study will investigate concept that prehospital lysis can be at least as good as primary PCI

Ingelheim, Germany (ots) - For scientific media outside the USA, Canada and Japan Boehringer Ingelheim announced today that it is undertaking a new initiative in the treatment of heart attack (ST-segment elevation myocardial infarction or STEMI). The company will sponsor a new clinical trial known as STREAM (STrategic Reperfusion Early After Myocardial Infarction). In STREAM, the bolus thrombolytic agent tenecteplase (Metalyse®) will be administered prehospitally to patients presenting early (within 3 hours) after symptom onset. "There are now several published reports suggesting that patients receiving lysis within two to three hours of symptom onset could have a lower mortality rate than patients undergoing a delayed primary percutaneous intervention (PCI),"1,2,3 said Professor Frans Van de Werf, chairman of the department of cardiology, University Hospital Gasthuisberg, Leuven, Belgium, and principal investigator of the STREAM trial. "The STREAM trial will provide prospective randomized data that could support the concept of at least parity between prehospital lysis and primary PCI in early-presenting patients. And, because STREAM uses the most up-to-date regimen of adjunctive agents (clopidogrel and enoxaparin), we might also gain information that could be invaluable for future treatment algorithms," Professor Van de Werf added. The announcement of the trial was made today during a satellite symposium held at the European Society of Cardiology congress in Vienna, Austria. "Thrombolysis continues to be the most rapidly and most widely available form of treatment for many, if not most, of those who suffer a heart attack. STREAM is intended to consolidate existing data showing that prehospital thrombolysis is not 'second-best' medicine but, rather, can yield patient outcomes as good as - or even better than - those obtained with primary percutaneous intervention (PCI)," explained Dr. Manfred Haehl, Corporate Senior Vice President Medicine, Boehringer Ingelheim. About STREAM STREAM (STrategic Reperfusion Early After Myocardial Infarction) is an open, parallel, randomized, exploratory multinational trial to evaluate the outcome of prehospital patients presenting with a large ST-elevation myocardial infarction within 3 hours of symptom onset. In this 2,000-patient trial, to be carried out at about 200 international sites, patients who cannot undergo PCI within an hour will be randomized to prehospital lysis or primary percutaneous intervention. It is important to note that STREAM is not a trial of lytic-facilitated PCI, in which all patients undergo immediate PCI. In STREAM, only lytic-treated patients who do not achieve 50 percent ST resolution after lysis will undergo immediate intervention; the others will have angiography (and any required follow-up) at 6 to 24 hours. STREAM is planned to begin in early 2008. About Metalyse® (tenecteplase) Tenecteplase is a single-bolus thrombolytic agent approved in the U.S.A. in 2000 and by the European Commission in 2001 for the treatment of acute myocardial infarction (AMI). Tenecteplase is the first "clot-buster" that can be administered over five seconds in a single bolus dose in the treatment of a heart attack. Tenecteplase is a bioengineered variant of Actilyse® (alteplase, recombinant), which is a recombinant DNA-derived version of naturally occurring tissue plasminogen activator (t-PA). It is constructed with amino acid substitutions at three sites (the letters T, N and K represent the three regions changed from the natural t-PA protein). These mutations enhance the agent's fibrin specificity, prolong the agent's half life, allowing bolus administration, and increase resistance to plasminogen activator inhibitor-1 (PAI-1). Safety Information All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, in elderly patients. About AMI Heart attack, or AMI, is caused when a blood clot obstructs a coronary artery supplying blood to the heart. This causes an inadequate flow of oxygenated and nutrient-enriched blood and results in the death of a portion of the heart muscle. Symptoms of a heart attack may include: uncomfortable pressure, fullness, squeezing or pain in the center of the chest that lasts for more than a few minutes; pain spreading to the shoulders, neck or arms; and chest discomfort with lightheadedness, fainting, sweating, nausea or shortness of breath. As many as 1.1 million Americans suffer heart attacks each year. Of these, about one-third will die, making heart attack the number one killer of men and women in the United States. About 650,000 of these cases are first attacks while 450,000 are recurrent attacks. Boehringer Ingelheim The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 144 affiliates in 47 countries and more than 38,000 employees. Since it was founded in 1885, the privately-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2006, Boehringer Ingelheim posted net sales of 10.5 billion euro while spending nearly one fifth of net sales in its largest business segment, Prescription Medicines, on research and development. For more information please visit www.boehringer-ingelheim.com Please be advised This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material. - ends - References: 1. Steg PG, et al: Impact of time to treatment on mortality after prehospital fibrinolysis or primary angioplasty: Data from theCAPTIM randomized trial. Circulation 2003:108;2851-2856 2. Danchin N, et al: Impact of prehospital thrombolysis for acute myocardial infarction on 1-year outcome results from the French USIC 2000 registry. Circulation 2004;110:1909-1915. 3. Kalla K, et al: Implementation of guidelines improves the standard of care: the Viennese registry on reperfusion strategies in ST-elevation myocardial infarction (Vienna STEMI registry). Circulation 2006;113:2398-2405. ots Originaltext: Boehringer Ingelheim Im Internet recherchierbar: http://www.presseportal.ch Contact: Contact: Ursula Bardon Corporate Division Communications Boehringer Ingelheim GmbH 55216 Ingelheim/Germany Phone: + 49 - 6132 - 77 26 22 Fax: + 49 - 6132 - 72 2622 E-mail: press@boehringer-ingelheim.com

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