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
"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.
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).
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.
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
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
In 2006, Boehringer Ingelheim posted net sales of 10.5 billion
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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
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