Prehospital Thrombolysis for AMI to be Studied in New Clinical Trial
04/09/2007 16:32
PR Newswire
INGELHEIM, Germany, September 4 /PRNewswire/ --
- Study Will Investigate Concept That Prehospital Lysis can be at
Least as Good as Primary PCI
- 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(R)) 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(R) (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(R)
(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 http://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.
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
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