NEWS HIGHLIGHTS
Published Studies Related to Reopro (Abciximab)
Effects of intracoronary compared to intravenous abciximab administration in patients undergoing transradial percutaneous coronary intervention: A sub-analysis of the EASY trial. [2009.08.14]
BACKGROUND: In the EASY trial, we have shown the clinical equivalence between abciximab bolus-only and abciximab bolus followed by 12-h infusion in a wide spectrum of patients after percutaneous coronary intervention (PCI). Some reports have suggested better outcomes following intracoronary (IC) abciximab administration compared to intravenous (IV) delivery. We sought to compare cardiac biomarkers release and early and late clinical outcomes after IC or IV abciximab bolus delivery... CONCLUSION: Compared to IV abciximab administration, IC abciximab was not associated with less cardiac biomarkers release or better clinical outcomes after uncomplicated transradial PCI. Further studies are required in clinical scenarios including patients with higher thrombotic burden and/or occluded vessels as in primary and rescue PCI.
Prognostic impact of blood transfusion after primary angioplasty for acute myocardial infarction: analysis from the CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) Trial. [2009.07]
OBJECTIVES: We sought to determine the relationship between red blood cell (RBC) transfusion and clinical outcomes in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND: The implications of RBC transfusion in patients undergoing primary PCI for AMI have not been evaluated... CONCLUSIONS: An RBC transfusion after primary PCI in AMI may be harmful, which is consistent with the findings from other studies after PCI in the noninfarct setting. Alternatively, RBC transfusion may be a marker of markedly increased risk. Randomized studies are warranted to determine the optimal threshold for RBC transfusion in patients with AMI undergoing mechanical reperfusion therapy.
Abciximab in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention after clopidogrel loading: a randomized double-blind trial. [2009.04.14]
CONCLUSIONS: Upstream administration of abciximab is not associated with a reduction in infarct size in patients presenting with acute myocardial infarction within 24 hours of symptom onset and receiving 600 mg clopidogrel.
Left ventricular function after ST-elevation myocardial infarction in patients treated with primary percutaneous coronary intervention and abciximab or tirofiban (from the Facilitated Angioplasty with Tirofiban or Abciximab [FATA] Trial). [2009.03.15]
Abciximab therapy during primary percutaneous coronary intervention (PCI) has shown to ameliorate left ventricular (LV) function recovery in patients with ST elevated myocardial infarction... Preprocedure Thrombolysis In Myocardial Infarction flow grade >0 seems to be the most important predictor of favorable LVEF and LV function recovery at 30 days.
Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial. [2008.12]
CONCLUSION: This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.
Clinical Trials Related to Reopro (Abciximab)
A Study of Abciximab and Reteplase When Administered Prior to Catherization After a Myocardial Infarction (Finesse) [Completed]
The purpose of this study is to determine whether abciximab given in combination with
reteplase, before patients have a coronary intervention (a standard treatment where a
catheter is inserted into the heart artery to get blood flowing past the clot), is safe and
effective in the treatment of heart attacks compared to only abciximab given during coronary
intervention.
ReoPro and Retavase to Treat Acute Stroke [Active, not recruiting]
This study will determine the dose of Retavase that can safely be combined with ReoPro in
treating acute ischemic stroke (stroke resulting from a blood clot in the brain). ReoPro and
Retavase are currently approved by the Food and Drug Administration to treat heart problems
caused by blockage of heart arteries. The only therapy approved by the Food and Drug
Administration to treat ischemic stroke is the clot buster drug rt-PA. This treatment is
effective only if begun within 3 hours of onset of the stroke, however, and most patients do
not get to the hospital early enough to benefit from it.
Patients between 18 and 80 years of age who have had a mild or moderate acute stroke between
3 and 24 hours before starting study drugs may be eligible for this study. Candidates will be
screened with a medical history and physical examination, blood tests, rating of neurological
deficits such as cognition deficits or problems walking that resulted from the stroke, and a
computed tomography (CT) scan of the head. CT involves the use of specialized X-rays to
obtain images of the brain. The patient lies on a table that is moved into a cylindrical
machine (the scanner) for the imaging study, which usually takes about 5 to 10 minutes.
All participants will receive 0. 25 mg/kg of ReoPro (maximum dose of 30 mg). The drug is
infused into the vein over 12 hours. Some patients will also receive one of four doses of
Retavase, which may boost the effectiveness of ReoPro in opening the blocked blood vessel.
Retavase is given through a needle in the vein over 2 minutes. Patients will be monitored
daily until discharge from the hospital, or until day 5, whichever is earlier. Assessments
will include physical examinations, blood tests to examine factors involved in blood
clotting, and CT scans to evaluate both the response to treatment and drug side effects. They
will return for a follow-up examination and CT scan 30 days after treatment.
ReoPro and Retavase to Restore Brain Blood Flow After Stroke [Active, not recruiting]
This study will evaluate the safety and effectiveness of two types of blood thinners,
abciximab (ReoPro) and reteplase (Retavase) for restoring normal brain blood flow after
ischemic stroke (stroke resulting from a blood clot in the brain).
The only therapy approved by the Food and Drug Administration to treat ischemic stroke is the
clot buster drug rt-PA. This treatment, however, is effective only if begun within 3 hours of
onset of the stroke and most patients do not get to the hospital early enough to benefit from
it. There is thus a pressing need to develop effective stroke treatments that can be
initiated more than 3 hours after onset.
Patients between 18 and 80 years of age who have experienced a mild or moderate acute stroke
between 3 and 24 hours before starting study drugs may be eligible for this study. Candidates
will be screened with a physical examination, blood tests and a magnetic resonance imaging
(MRI) scan (if an MRI was not done during the stroke evaluation).
All participants will receive ReoPro. Some will also receive Retavase, which may boost the
effectiveness of ReoPro. Retavase is administered in a single dose through a needle in the
vein over 2 minutes. ReoPro is infused into the vein over 12 hours. Patients will be
monitored with physical examinations, blood tests, computed tomography (CT) scans, and three
or four MRI scans of the brain to evaluate both the response to treatment and side effects of
the drugs. An MRI scan will be done 24 hours, 5 days and 30 days after starting the study
medication, and possibly during screening for this study.
CT involves the use of specialized x-rays to obtain images of the brain. The patient lies
still in the scanner for a short time while the X-ray images are formed. MRI uses a strong
magnetic field and radio waves to demonstrate structural and chemical changes in tissue. MRI
is more sensitive than x-ray in evaluating acute stroke. The patient lies on a table in a
metal cylinder (the scanner) while the pictures are being taken. During part of the MRI, a
medicine called gadolinium contrast is injected in a vein. This medicine brightens the
images, creating better pictures of the blood flow.
FATA: Randomized Study on Facilitated Angioplasty With Tirofiban or Abciximab [Completed]
The elective("standard of care") treatment of ST - elevation acute myocardial infarction
(STEMI) currently consists of primary angioplasty with stent implantation during
administration of Abciximab, a inhibitor of GP IIb/IIIa platelet receptor.
Tirofiban is another potent inhibitor of GP IIb/IIIa platelet receptor with an efficacy on
platelet aggregation inhibition equal to or greater than Abciximab if a high dose bolus is
used, i. e. 25 microg/kg, (platelet aggregation inhibition > 90% 15 minutes after infusion).
It can therefore be hypothesized that this drug can improve the results of primary
angioplasty to the same extent as Abciximab.
The aim of this study is to compare the efficacy, in terms of myocardial reperfusion indices,
of Abciximab and high dose of Tirofiban in primary angioplasty for STEMI, both in the case of
treatment before transfer and of treatment in the catheterization laboratory during the
procedure.
The reference hypothesis for the study objective is the equivalence or the non-inferiority of
Tirofiban with respect to Abciximab.
A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab [Completed]
The purpose of this study is to compare the effectiveness and safety of intracoronary
stenting with or without abciximab, an anti-platelet therapy, and conventional coronary
angioplasty with abciximab in patients undergoing percutaneous coronary intervention.
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