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STENT/CORONARY
INTERVENTION TRIALS
The ACS Catheterization
Laboratory runs a busy, top quality Coronary Intervention program. This
makes it an ideal site for select, cutting-edge research trials in the setting of Coronary
Heart Disease, Unstable Coronary Syndromes, including Acute Myocardial Infarction
(heart attack"), and Stenting of Coronary Arteries (a stent is a metallic
device introduced into an artery to keep it open and decrease the chances of re-closure
after an angioplasty).
List Of Hospital-Based Trials Currently
Enrolling Patients
CADILLAC:
ACS treats all eligible patients with an acute or evolving heart attack with
primary or direct angioplasty (mechanically opening up the occluded coronary artery by
angioplasty or stent). This trial involves a randomized comparison of the new Rx
Multi-Link Coronary Stent System versus direct balloon angioplasty in the treatment
of patients presenting with Acute Myocardial Infarction. Patients are followed up in the
office at two weeks and four weeks after the procedure. Some patients return at six months
for a repeat diagnostic coronary angiogram. Sponsor: Advanced Cardiovascular Systems, Inc.
/ Lilly Research Laboratories, 1998 to present.
ADMIRE:
In acute myocardial
infarction, cell death is due to both prolonged ischemia (from a blocked artery) and
reperfusion injury (on re-establishing flow to the myocardium). AMP579 is an adenosine
agonist that attempts to combat reperfusion injury. The objective of this trial is to
increase salvage of jeopardized heart muscle, following direct angioplasty in acute
infarction. Since AMP579 is an A1 and A2 adenosine receptor agonist, it has a superior
cardioprotective profile over currently available selective A1 receptor agonists. In this
randomized, placebo-controlled trial, the drug is administered intravenously over six
hours at presentation to the cath lab/Coronary Care Unit. Patients are followed up at four
-to-six weeks and at six months, to assess the volume of myocardial salvage and the
improvement in global heart contractility. Sponsor: Rhone-Poulenc Rorer / Mayo
Physicians (M-PACT), 1997 to present.
SYMPHONY:
This is a multicenter,
international randomized, double-blind trial to evaluate the safety and efficacy of a oral
Sibrafiban in the prevention of secondary vascular events in patients after an
acute coronary syndrome. The initial event in an acute coronary syndrome is the
aggregation of platelets (a specialized line of blood cells); the final event is usually
the formation of an intracoronary thrombus, which occludes coronary blood flow. Sibrafiban
is a new and advanced potent and selective antagonist of a specific platelet surface
receptor, that inhibits platelet aggregation. The objective of the trial is to
prevent/minimize repeat coronary vascular events in these patients. It is administered
orally for a period of 90 days, and patients are followed up with regular office visits at
two weeks, one, three, six, and twelve months. Sponsor: G.D. Searle & Co.,
1998 to present.
WINS:
This trial evaluates a new stent in the
treatment of graft closure. It enrolls post-coronary bypass surgery patients presenting
with stenosis (closure) or restenosis (re-closure) in one or more coronary grafts.
Eligible patients receive the Schneider Wall Stent and are followed regularly in the
office for about one year. Patients also fill out a QOL (quality of life) questionnaire at
six months and then every year. Sponsor: Schneider (USA) Inc., 1997 to present.
GUARDIAN:
This trial evaluates a new and adjuvant
approach to prevent myocardial cell necrosis in severe myocardial ischemia, by inhibiting
(sodium -hydrogen) ionic exchange at the plasma membrane level. The drug Cariporide
is used to prevent actual cell destruction, rather than just limiting the size of
myocardial infarction (cell death). It involves a randomized, double-blind,
placebo-controlled trial where the drug is administered as an intravenous infusion thrice
daily, for two to seven days. Patients are followed up for six months following the
procedure, for all-cause mortality and repeat infarction related to the disease process or
to an interventional procedure. Sponsor: Hoechst Marion Roussel / Quintiles, 1997
to present.
AIR PAMI:
This trial compares the
effectiveness of thrombolytic therapy ("clot busters") versus direct infarct
intervention (primary angioplasty) as the first line of treatment in high-risk patients
presenting with acute myocardial infarction. Collaboration with: William Beaumont
Hospital, University of Michigan, 1996 to present.

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