Retavase® (Reteplase) is a non-glycosylated deletion mutein of tissue plasminogen activator (tPA), containing the kringle 2 and the protease domains of human tPA. Retavase® contains 355 of the 527 amino acids of native tPA (amino acids 1-3 and 176-527). Retavase® is produced by recombinant DNA technology in E. coli. The protein is isolated as inactive inclusion bodies from E. coli, converted into its active form by an in vitro folding process and purified by chromatographic separation.
Retavase® (Reteplase) is indicated for use in the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms (see CLINICAL PHARMACOLOGY).
Published Studies Related to Retavase (Reteplase)
Abciximab combined with half-dose reteplase has beneficial effects on inflammatory myocardial response in patients with myocardial infarction. [2009.03]
In patients with ST-segment elevation myocardial infarction (STEMI), myocardial reperfusion is associated with an inflammatory response leading to adverse effects on further myocardial damage. Therefore, we investigated the effects of the thrombolytic regimen with half-dose reteplase (r-PA) combined with abciximab on different cytokines involved in the local and systemic inflammatory scenario in STEMI patients...
Immediate angioplasty versus standard therapy with rescue angioplasty after thrombolysis in the Combined Abciximab REteplase Stent Study in Acute Myocardial Infarction (CARESS-in-AMI): an open, prospective, randomised, multicentre trial. [2008.02.16]
BACKGROUND: Thrombolysis remains the treatment of choice in ST-segment elevation myocardial infarction (STEMI) when primary percutaneous coronary intervention (PCI) cannot be done within 90 min. However, the best subsequent management of patients after thrombolytic therapy remains unclear. To assess the best management, we randomised patients with STEMI treated by thrombolysis and abciximab at a non-interventional hospital to immediate transfer for PCI, or to standard medical therapy with transfer for rescue angioplasty... INTERPRETATION: Immediate transfer for PCI improves outcome in high-risk patients with STEMI treated at a non-interventional centre with half-dose reteplase and abciximab.
Primary percutaneous coronary intervention of an unprotected left main using mini-crush drug-eluting stents facilitated by intracoronary reteplase. [2011.03.01]
Patients suffering from acute myocardial infarction with involvement of unprotected left main (LM) coronary artery disease represent a very high-risk subgroup. A 37-year-old male patient was admitted with posterolateral acute myocardial infarction and in borderline hemodynamic condition... The patient recovered without complications and had a favorable outcome at mid-term.
Thrombolysis with reteplase for recurrent mechanical heartvalve thrombosis. [2011.02]
Thrombotic occlusion of a prosthetic valve continues to be an uncommon but life threatening complication of mechanical valves. However, recurrent prosthetic valve thrombosis is yet a rare complication... We report the first three cases of recurrent prosthetic mitral valve thrombosis in Pakistan which were treated with Reteplase that resulted in re-establishment of adequate blood flow across the valve with reduction of mean gradient to normal.
Effect of Reteplase and PAI-1 antibodies on postoperative adhesion formation in a laparoscopic mouse model. [2009.05]
BACKGROUND: Postoperative adhesions remain an important clinical problem, accounting for infertility, chronic pain and bowel obstruction. Its prevention is still inadequate and overall poorly understood. The aim of this study was to investigate the effect of Reteplase (a recombinant plasminogen activator, r-PA) and of PAI-1 antibodies upon adhesion formation in a laparoscopic model... CONCLUSIONS: Low-dose i.p. administration of rPA is effective in the prevention of adhesions in a laparoscopic mouse model.
Clinical Trials Related to Retavase (Reteplase)
ReoPro and Retavase to Restore Brain Blood Flow After Stroke [Completed]
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.
ReoPro and Retavase to Treat Acute Stroke [Completed]
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
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.
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
Pre-hospital Administration of Thrombolytic Therapy With Urgent Culprit Artery Revascularization [Completed]
The PATCAR study has been designed to test the hypothesis that the strategy of pre-hospital
use of a "clot busting" (thrombolytic) drug followed with emergent heart catheterization
including stenting of the problematic coronary artery, will result in a lower mortality and
reduced repeat heart attack rates.
Early identifying and treating heart attacks patients prior to the arriving at the hospital,
in those patients who qualify for the "clot busting" drugs will lower the size of the heart
attack damage. This smaller heart attack will lead to fewer problems with less repeat heart
attacks and death in the future.
CARESS in Acute Myocardial Infarction [Completed]
The aim of this study conducted in patients with high risk ST-segment elevation AMI
admitted to hospitals with no PTCA facilities is to compare the effects on clinical outcome
and cost-effectiveness of two reperfusion strategies:
- Fibrinolytic therapy with Abciximab and half-dose Reteplase, with rescue PTCA in case
of lack of reperfusion
- Elective referral for “facilitated” PTCA after early administration of Abciximab and
half dose of Reteplase
Page last updated: 2011-12-09