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Bivalirudin is recomended by guidelines during primary PCI procedure for patients with STEMI. However, there is a large number of STEMI patients who missed the primary PCI. So the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.
Antithrombotic therapy is essential to prevent adverse ischemic events, especially stent thrombosis and reinfarction during and after primary percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI). Bivalirudin is emerging as an alternative for heparin during PCI procedure1.
Bivalirudin (BIV) a synthetic, bivalent, 20-amino acid direct thrombin inhibitor, was found to have the advantages of inhibiting fibrin-bound thrombin, a predictable effect of anticoagulation, and a short half-life of approximately 30 minutes in humans with normal renal function. BIV has been introduced in percutaneous coronary interventions (PCIs) especially for patients with ACS. Compared with heparin, series clinical trials indicated that BIV was not inferior to UFH as a procedural anticoagulant and there was no increased bleeding.
In the real world, there are as many as 47.1% patients with STEMI can not get early reperfusion therapy. Huge number of patients missed the best time window for PCI. For these patients, the usual PCI procedure are usually performed 1-2 weeks after attack, which is called late PCI.
For patients with STEMI, Bivalirudin is recomended by guidelines in ESC during PCI procedure. However, the evidences (ACUITY，HORIZONS-AMI，EUROMAX, EAT-PPCI，BRIGHT, VALIDATE-SWEDEHEART) supporting the guideline nearly all comes from primary PCI for STEMI, which means there has no clinical trials focus on late PCI for patients with STEMI yet.
Clinically, late PCI, defined as the time to open an infarct‐related artery (IRA) from symptoms onset > 7 days (when the myocardial condition is considered stable), is practiced commonly for these late presenters. Whether late PCI is adequately beneficial is controversial. Currently, heparin is applied during late PCI as the anticoagulation therapy, it is still unknown of the efficiency and safety for bivalirudin as the anticoagulation therapy during late PCI.
So in this RCTs, the investigators aim to study the efficiency and safety of bivalirudin as the anticoagulation therapy during late PCI.
we Focuse on the Efficiency and Safety of Bivalirudin During Late PCI
Not yet recruiting
Second Xiangya Hospital of Central South University
Published on BioPortfolio: 2019-12-10T01:21:21-0500
This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coron...
This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.
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The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
This study will evaluate heparin as compared to bivalirudin for systemic anticoagulation in adult patients that require extracorporeal membrane oxygenation (ECMO). Half of the participants...
Bivalirudin, a direct thrombin inhibitor, is a treatment option for the management of heparin-induced thrombocytopenia (HIT) and other coagulation disorders. To date, no published studies have identif...
Bivalirudin, a direct thrombin inhibitor with a fast onset of action and short half-life, is often referred to as an alternative anticoagulant to a heparin/protamine regimen. Bivalirudin demonstrated ...
A pharmacoinvasive strategy for ST-segment elevation myocardial infarction (STEMI) management combines the use of fibrinolysis with the routine transfer to coronary angiography, with percutaneous coro...
Safety and efficacy of bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes with positive biomarkers undergoing percutaneous coronary intervention: a report from the Acute Catheterization and Urgent Intervention Triage Strategy trial.
There are limited data on bivalirudin monotherapy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) with positive biomarkers of myocardial necrosis (troponin and/or creatin...
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Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Coagulant substances inhibiting the anticoagulant action of heparin.
Using certified ELECTRONIC HEALTH RECORDS technology to improve quality, safety, efficiency, and reduce HEALTHCARE DISPARITIES; engage patients and families in their health care; improve care coordination; improve population and public health; while maintaining privacy and security.
A heparin fraction with a mean molecular weight of 4500 daltons. It is isolated from porcine mucosal heparin and used as an antithrombotic agent. (From Merck Index, 11th ed)
Heparin fractions with a molecular weight usually between 4000 and 6000 kD. These low-molecular-weight fractions are effective antithrombotic agents. Their administration reduces the risk of hemorrhage, they have a longer half-life, and their platelet interactions are reduced in comparison to unfractionated heparin. They also provide an effective prophylaxis against postoperative major pulmonary embolism.
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