NEWS HIGHLIGHTS
Published Studies Related to Reopro (Abciximab)
A randomized two-by-two comparison of high-dose bolus tirofiban versus abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary revascularization and stent placement: the tirofiban evaluation of novel dosing versus abciximab with clopidogrel and inhibition of thrombin (TENACITY) study trial. [2011.06.01]
CONCLUSION: With limited assessment, this direct comparison of high-dose bolus tirofiban versus abciximab produced encouraging results and suggests that further study of this tirofiban dose regimen is warranted. The limited assessments comparing heparin and bivalirudin are consistent with prior observations. Copyright (c) 2010 Wiley-Liss, Inc.
Intracoronary versus intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: 6-month effects on infarct size and left ventricular function. The randomised Leipzig Immediate PercutaneouS Coronary Intervention Abciximab i.v. versus i.c. in ST-Elevation Myocardial Infarction Trial (LIPSIAbciximab-STEMI). [2011.05]
BACKGROUND: Administration of abciximab during primary percutaneous coronary intervention (PCI) reduces major adverse cardiac events (MACE) in patients with ST-elevation myocardial infarction (STEMI). Intracoronary (IC) abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction early after infarction. Aim of this study was to investigate whether the early benefits of an IC abciximab administration in STEMI patients undergoing PCI are sustained at 6 months... CONCLUSIONS: Intracoronary abciximab application in STEMI patients undergoing PCI is superior to standard IV treatment with respect to infarct size, recovery of LV function and reverse remodelling 6 months after infarction.
Intracoronary compared to intravenous bolus abciximab during primary percutaneous coronary intervention in ST-segment Elevation Myocardial Infarction (STEMI) patients reduces 30-day mortality and target vessel revascularization: a randomized trial. [2011.04]
BACKGROUND: Abciximab is beneficial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI). However, the optimal administration route of the initial bolus of abciximab, that is, intravenous (IV) versus intracoronary (IC), has been questioned. Preliminary studies suggest that IC-bolus is superior, probably due to high local concentration. In this study, we assess the short-term efficacy and safety of IC compared to IV bolus of abciximab in patients with STEMI during pPCI... CONCLUSION: IC administration of bolus abciximab in STEMI patients undergoing pPCI reduces 30-day mortality and TVR and tends to reduce MI, compared to IV-bolus. (c)2010, Wiley Periodicals, Inc.
Rationale and design of the INFUSE-AMI study: A 2 x 2 factorial, randomized, multicenter, single-blind evaluation of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST-segment elevation myocardial infarction. [2011.03]
BACKGROUND: Whether thrombus aspiration and local glycoprotein IIb/IIIa administration reduce infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not been established in multicenter studies.SUMMARY: INFUSE-AMI is testing the hypothesis that the intracoronary administration of an abciximab bolus with or without thrombus aspiration before stent implantation compared to no infusion with or without thrombus aspiration reduces infarct size among patients undergoing primary PCI for anterior STEMI who are treated with bivalirudin.
Abciximab does not prevent ischemic lesions related to cerebral angiography: a randomized placebo-controlled trial. [2011]
BACKGROUND: To assess the efficiency of IIb/IIIa platelet receptor inhibition by abciximab in the prevention of silent embolism during digital subtraction angiography... CONCLUSIONS: IIb/IIIa receptor inhibition by abciximab does not diminish the occurrence of silent embolism during digital subtraction angiography. Our findings indicate that solid blood clots are not the origin of hyperintense lesions observed on DWI and enhance the role of alternative mechanisms. Copyright (c) 2011 S. Karger AG, Basel.
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.
Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI [Recruiting]
The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended
by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to
potential increase of bleeding. Compared bolus injection followed by continuous infusion of
Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding
complication while maintaining decrease ischemic events. It was also reported that direct
intracoronary injection of abciximab might be superior to intravenous injection regarding
myocardial perfusion.
Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of
acute ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that
combination of intracoronary abciximab bolus injection and aspiration thrombectomy might
enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial
infarction. We will determine whether combination of intracoronary abciximab injection and
aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion
through index of microcirculatory resistance and cardiac magnetic resonance imaging.
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.
Reports of Suspected Reopro (Abciximab) Side Effects
Death (15),
Haemorrhage (7),
Thrombosis in Device (7),
Incorrect Route of Drug Administration (6),
Myocardial Infarction (6),
Thrombocytopenia (6),
Pulmonary Haemorrhage (6),
Cerebral Haemorrhage (5),
Haemorrhage Intracranial (5),
Renal Failure (5), more >>
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