View clinical trials related to Acute Coronary Syndrome.
Filter by:This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).
Acute coronary syndrome is defined as myocardial infarction or ischemia as evidenced by significant coronary artery disease on cardiac catheterization/revascularization or reversible defect seen on stress test. Each year approximately 8-10 million patients undergo an emergency department evaluation for possible acute coronary syndrome (ACS) in the United States Up to 8%of patients who have myocardial infarction (MI) are inadvertently discharged. Unnecessary admissions for presumed myocardial disease result in health care costs that are estimated to exceed 5 billion dollars annually Currently, the cardiac biomarkers troponin and Creatine phosphokinase (CPK-MB), in conjunction with ECG changes are used to evaluate a patient routinely for ACS. However, these tests have limitations for identifying most patients who have ACS in a rapid fashion. Purine molecules such as inosine and hypoxanthine and have been shown to also be biomarkers of acute MI. High pressure liquid chromatography (HPLC) is the traditional method of analysis of these purines. The HPLC method however requires hours to assess biomarkers, as do the more traditionally used troponin and CK-MB methods. Recently, the investigator has developed a rapid chemo luminescence method for detecting purine biomarkers. This modality can provide an expeditious (requires less than 4 minutes to complete analysis), bedside method of analysis for ACS through routinely acquired blood samples. In this study the investigator will compare the results of the chemo luminescence method with the gold standard HPLC method, and results of the traditional cardiac markers troponin and Creatine phosphokinase (CK-MB) in patients undergoing an evaluation for ACS. Details of noninvasive and invasive cardiac assessments performed as part of the routine evaluation by the clinician for myocardial assessment and intervention in conjunction with biomarker assessment will be obtained. The investigator hypothesize that the rapid chemo luminescence biomarker assessment will identify patients with ACS faster than traditional diagnostic methods. The goal of this study is to assess the role of rapid assessment of purine biomarkers in identifying patients who may have ACS.
Study of persistent platelet reactivity during acute coronary syndrome. Patients are included at admission to the hospital. Platelet aggregation is evaluated by platelet function testing after blood sampling during hospitalization. No changes in treatment is planned.
The investigators hypothesized that ticagrelor may enhance endothelial healing after DES implantation by increasing adenosine concentrations by the inhibition of adenosine uptake into erythrocytes, compared to clopidogrel. Thus, the investigators will evaluate the extent of endothelialization (stent strut coverage) and neointimal hyperplasia (neointimal thickness) 3 months after DES implantation by optical coherence tomography (OCT)
Evaluating safety and PK parameter of APD-791 when co-administered with aspirin and clopidogrel.
Study design Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Prasugrel during the Percutaneous Coronary Intervention. Patients with acute coronary syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Prasugrel (60 mg). In patients with non-ST elevation myocardial infarction these drugs will be administered only when the coronary anatomy will be known, to avoid bleeding due to prasugrel, in patients suitable for coronary artery bypass grafting as recommended by European Society of Cardiology guidelines (Class IB) (10). In patients with ST elevation myocardial infarction, instead, prasugrel and ticagrelor will be administrated before the procedure, according to the European Society of Cardiology guidelines (Class IB) (11). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions. Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with acute coronary syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System. Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. . In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
The administration of these drugs is realized according to the European Society of Cardiology guidelines. All patients will be pretreated with aspirin 300 mg orally, heparin iv to maintain an activated clotting time of >250 sec, and a loading dose of ticagrelor (180 mg) or clopidogrel (600 mg) immediately before the revascularization. The list of assignment to ticagrelor or clopidogrel will be generated by a computer according to a 1:1 randomization. Primary Percutaneous Coronary Intervention will be performed according to standard clinical practice using femoral or radial artery Judkins approach via six or seven French heath insertion. After crossing the target occlusive Lesion, coronary stenting will be performed based on standard practice. Patients subsequently will receive heparin for 48 hr, aspirin 100 mg daily, and clopidogrel (75 mg/day) or ticagrelor (90 mg twice daily) for at least 12 months. Other adjunctive pharmacotherapy in Intensive Care Unit will be administered according to operator discretion. All patients will provide written informed consent before entering the study. Before and after the procedure a 12-leads ECG and an echocardiogram will be performed as standard practice. Then, all the pre-, intra-, and post-procedure data patients will be collected in a database. Investigators aim to perform a prospective, single-center, investigator-initiated, randomized study to compare the Adenosine-induced coronary vasodilatation after the loading dose of Ticagrelor either Clopidogrel during the Percutaneous Coronary Intervention. Patients with Acute Coronary Syndrome undergoing Percutaneous Coronary Intervention will be enrolled in the study and will be randomized, in a 1:1 ratio, to receive a loading dose of Ticagrelor (180 mg) or Clopidogrel (600 mg). Coronary Flow Reserve will be recorded by intracoronary Doppler Flow Wire before the stent implantation and after the procedure at baseline and 2-minute later adenosine intravenous administration at incremental doses of 50, 80, 110 and 140 ug/Kg/min with 2 minutes interval between infusions. Coronary Flow Reserve is the ability of the myocardium to increase blood flow in response to maximal exercise. Doppler Flow Wire allows to measure this increase expressing it as a ratio between maximal vasodilation and flow at rest. Coronary Flow Reserve is routinely measured in patients with Acute Coronary Syndrome, without an increased risk of adverse events for patients neither adjunctive costs for the National Health System. Furthermore, Plasma concentrations of Ticagrelor and its main metabolite (AR-C124910XX) will be measured in venous blood collected at the end of the procedure. In patients requiring a second Percutaneous Coronary Intervention, for example for multivessel disease, all these measures will be repeated in the same manner.
The aim of the study is to evaluate surgery-related bleeding and mortality in patients needing acute coronary artery bypass grafting with or without valve replacement during dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker (Clopidogrel, Prasugrel, Ticagrelor)
Clopidogrel and Prasugrel are pro-drug necessitating conversion in active metabolites through CYP 450 system (CYP), particularly CYP3A and CYP2C19 isoforms. These drugs are platelet purinergic receptor antagonists, known as P2Y12. The link between active metabolite of Clopidogrel and Prasugrel to P2Y12 receptor prevents ADP receptor activation and inhibits several events leading to conformational change of platelets, therefore facilitating their activation and aggregation, that is the basis of acute coronary syndromes. Proton pump inhibitors (PPI) are actually considered principal agents reducing gastroenteric bleeding risk associated to antiplatelet therapy. Nevertheless the interaction between PPI and antiplatelet therapy has been object of interest. Several studies demonstrated PPI reduce efficacy of clopidogrel on platelet reactivity. Only few data about Prasugrel are available showing a minor effect of PPI on its antiplatelet activity than clopidogrel. Differing from prasugrel and clopidogrel, ticagrelor is a direct inhibitor of P2Y12, not necessitating biotransformation in the liver; therefore its interaction with PPI remains unclear. Interaction between omeprazole and clopidogrel seems related to high inhibitory activity of PPI on CYP2C19, interfering with the conversion of clopidogrel in its active metabolite.
This VISION study aims to investigate the role of inflammation in atherosclerosis using 68Ga- DOTATATE PET, and to validate 68Ga-DOTATATE PET imaging for the detection and quantification of vascular inflammation in the aorta, coronary and carotid arteries. This study will test the hypothesis that in subjects undergoing carotid endarterectomy for symptomatic plaques, there will be a positive correlation between carotid artery 68Ga-DOTATATE PET signal and the underlying degree of carotid inflammation measured by immunohistochemical analysis.