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Stable Angina clinical trials

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NCT ID: NCT01016041 Completed - Clinical trials for Acute Coronary Syndrome

A Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial

COMPARE 1
Start date: February 2007
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00984776 Completed - Clinical trials for Coronary Artery Disease

Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging

T9M
Start date: March 2007
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00876512 Completed - Stable Angina Clinical Trials

CYP2C19 Gene Alteration and Thienopyridine Resistance in Percutaneous Coronary Intervention Study

CALDERA-PCI
Start date: December 2008
Phase: N/A
Study type: Observational

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.

NCT ID: NCT00857441 Completed - Clinical trials for Coronary Artery Disease

Drug-eluting Balloon in Bifurcations Trial

DEBIUT
Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT00821834 Completed - Clinical trials for Myocardial Infarction

Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned

CLEAN
Start date: December 2008
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00719992 Completed - Stable Angina Clinical Trials

Diagnostic Value of HS-CRP in Stable Angina.

Start date: April 2006
Phase: N/A
Study type: Interventional

The aim of this study was to assess the amount of additive value of HS-CRP levels to a positive exercise tolerance test (ETT) in predicting coronary artery disease (CAD) using coronary angiography as the gold standard. The investigators concluded that HS-CRP can be used as a single predictor of coronary vessel involvement in patients with stable angina and positive ETT.

NCT ID: NCT00607217 Completed - Clinical trials for Myocardial Infarction

The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases

Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

This study wishes to understand: 1. whether vaccination against influenza in coronary artery disease (myocardial infarction and stable angina) patients is as effective as it is in healthy subjects; 2. whether vaccination really decreases the episodes of influenza infection in those coronary artery disease patients who receive the vaccine than those who do not.

NCT ID: NCT00607178 Completed - Clinical trials for Myocardial Infarction

The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases

IVCAD
Start date: January 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).

NCT ID: NCT00474123 Completed - Stable Angina Clinical Trials

Antiplatelet and Anti-inflammatory Effects of Statins and Ezetimibe

Start date: January 2006
Phase: N/A
Study type: Interventional

Among patients with stable coronary artery disease (CAD), it is not clear if the pleiotropic effects of cholesterol reduction differ between high-dose simvastatin alone and combined ezetimibe/simvastatin. The investigators sought to compare the anti-inflammatory and anti-platelet effects of ezetimibe 10 mg / simvastatin 20 mg (E10/S20) to simvastatin 80 mg (S80).

NCT ID: NCT00263263 Completed - Clinical trials for Coronary Artery Disease

RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.

Start date: September 2003
Phase: Phase 2
Study type: Interventional

Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in native coronary arteries reducing the occurrence of restenosis and repeated revascularization, however saphenous vein grafts have been always excluded form randomized trials. Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with respect to bare-metal-stents in degenerated vein grafts. Design: Double-blind randomized controlled non-industry-sponsored trial. Setting: A single-center tertiary-care referral hospital. Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the corresponding bare-metal-stent. All patients are followed clinically and repeated angiographic follow-up is performed in all at 6-months. Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss. Secondary end-points include: binary angiographic in-stent and in-segment restenosis, intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events (death, myocardial infarction, target-lesion and target-vessel revascularization).