View clinical trials related to Angina, Stable.
Filter by:The register study CGM@CAD will examine whether cardiogoniometry can provide additional information concerning the indication for a diagnostic coronary angiography and if so, which additional value it has. Therefore, an additional cardiogoniometry will be carried out in consecutive patients who have been diagnosed with myocardial ischemia by means of established methods (exercise ECG, stress echocardiography, myocardial scintigraphy, or stress-MRT) and for whom an intracardiac catheter examination is regarded as indicated. The results of the different methods - particularly the results of the exercise ECG and the cardiogoniometry - will be checked against the results of the invasive examination as gold standard and the discharge diagnosis with regards to any correlation.
The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI).
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients. Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).
Instead of treating in-stent restenosis, the best strategy for patients is preventing in-stent restenosis. Recent advances in the understanding of the cellular mechanism responsible for smooth muscle cell proliferation (neointimal hyperplasia), together with improvement in stent coating and eluting technology have provided the scientific background to develop drug eluting stents. Drug eluting stents (DES) are now the most promising development in interventional cardiology. Different classes of drugs mounted in a polymer layer on the surface of the stent have shown to be very effective in preventing neointimal hyperplasia. Currently there are 7 DES stents CE marked and commercially available on the market. Two stents, respectively the sirolimus eluting Cypher™ stent and the paclitaxel eluting Taxus™ stent, are in clinical use since 2002. The Cypher™ stent consists of the Bx sonic stent/balloon platform. The stent is coated with a non-degradable biocompatible PBMA/PEVA polymer which elutes sirolimius. The Taxus™ stent consists of the Express2 balloon/stent platform coated with non-degradable biocompatible Translute™ polymer which elutes paclitaxel. Recent large randomized trials like RAVEL, SIRIUS, E-SIRIUS C-SIRIUS (Cypher™ versus bare metal BX sonic™ stent), TAXUS II, IV, V, VI (Taxus versus bare metal Express™ stent) have shown that DES dramatically reduce the incidence of in-stent restenosis and subsequently the need for target lesion revascularization in patients with non complex and moderate long de-novo coronary lesions in vessels with a diameter between 2.5 -3.5 mm.1-11 Considering the very encouraging results of these early clinical trials with so far mid long term follow-up, there is the need to explore the utilization of DES in the other subsets of coronary lesions like: long lesions, chronic total occlusions, venous graft lesions, thrombotic lesions, restenosis lesions, ostial and bifurcation lesions and lesions in large vessels. As the result from the previous reported randomized trials, FDA and other regulatory institutes require that new DES are now being evaluated against one of the former DES (Cypher or Taxus). The XIENCE-V stent is a second generation DES, with thinner and more flexible Cobalt-Chromium stent struts, compared to the first generation Stainless Steel stent struts of Cypher and Taxus. This study addresses the questions whether the XIENCE-V™ stent has superior clinical results as the Taxus™ stent in the general population that is being referred for percutaneous coronary intervention (PCI). Objective of the study: The main objective of the study is a head tot head comparison of the everolimus coated XIENCE-V™ stent with the paclitaxel coated TAXUS™ stent in order to observe whether there is a difference in clinical outcome between both stents. Efficacy of both stents will be assessed by the composite end point of: all death, non fatal myocardial infarction and target vessel revascularization. Study design: Single center, randomised, open label study in all-comers referred for PCI. Study population: Approximately 1600 consecutive patients with coronary artery disease who are eligible according to the in- and exclusion criteria will be enrolled and randomized on a 1:1 basis. Primary study parameters/outcome of the study: The primary end point of the study is the composite end point of: all death, non fatal myocardial infarction, target vessel revascularization at 1 year. Secondary study parameters/outcome of the study: The secondary end points of the study are: A) The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 1, 6 and 12 months follow-up. B) The combined endpoint of all death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 2, 3, 4 and 5 years. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for the patient consists of filling in 8 questionnaires (1 A4 per questionnaire) in 5 years time. The first 3 questionnaires in the first year are also requested for monitoring purposes by the Ministry of Health and the Dutch Cardiology Society (Nederlandse Vereniging Voor Cardiologie; NVVC). There is no risk for the patient related to participation in this study. The patient will receive a Taxus or Xience-V stent anyhow, if the indication for a DES stent exists.
The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe
MRI has the ability to visualize the arterial vessel wall. Wall thickening and atherosclerotic plaque components can be visualized in the carotid arteries and the aorta. Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall. The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial infarction. The goal of this study was to validate MRI of the coronary vessel wall by comparing it to intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall and to look at the uptake of the albumin-binding contrast agent gadofosveset in atherosclerotic plaques. The main hypothesis is that due to the albumin binding characteristics, uptake of the contrast agent will take place in the more vulnerable plaques compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and intravascular ultrasound, two techniques currently considered as the standard of reference for imaging of the coronary arteries and vessel wall.
Dual antiplatelet therapy with aspirin and thienopyridines decreases the rate of stent thrombosis in patients undergoing percutaneous coronary intervention (PCI). However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance. The present study is designed in order to clarify the influence of CYP2C19 genetic polymorphism on the several biomarkers for platelet activation in Japanese patients treated with thienopyridines undergoing elective PCI.
The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: 1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement). 2. Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.
Primary objective: - To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned. Secondary objectives: - To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine. - To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine. - To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks; - To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.
The purpose of this study is to determine the anti-angina effect and dose response of T89, a 2-herb botanical drug product, in patients with chronic stable angina pectoris in the United States.