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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.

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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