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Acute Coronary Syndrome clinical trials

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NCT ID: NCT02226523 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Magnetic Nanoparticles System in Acute Coronary Syndrome

Start date: February 2014
Phase:
Study type: Observational [Patient Registry]

To improve the sensitivity and specificity of immunoassay, the developing trends are to lower the detection threshold and to minimize the cross reaction. A new assay technology called immunomagnetic reduction (IMR) has been developed for rapid and on-site assay with small volume of sample. Rapid diagnosis of acute coronary syndrome (ACS) is a clinical and operational priority in busy emergency departments (ED), early and correct diagnosis is important. Cardiac enzymes (including CPK/CK-MB, troponins, myoglobulin) and electrocardiography (ECG) in combination with the medical history and physical examination are at present the diagnostic cornerstones. Novel biomarkers that rise earlier, have good diagnosis accuracy and have additional prognostic information are highly needed. The combination of multiple biomarker assays (markers of myocardial injury, inflammation/plaque ruptures or heart failure with different mechanism) may increase clinical sensitivity and improve early risk stratification. The present study, a rapid IMR assay with multiple biomarkers is proposed and we will examine the performance of this new investigational IMR assays, comparison with current commercial assays.

NCT ID: NCT02200783 Active, not recruiting - Clinical trials for Acute Coronary Syndromes

Randomized Comparison of Radiological Exposure With TRIPTable® in Patients With Acute Coronary Syndromes

TRIPTABLE
Start date: July 2014
Phase: N/A
Study type: Interventional

Excessive radiation received by the operator has been described as a possible drawback of the radial catheterization technique when compared with the femoral access. The study hypothesis is that the use of radial access device dedicated radioprotective TRIPTable ® (Transradial Intervention Table Protection) is not inferior to standard femoral technique and superior to standard radial technique as radioprotection strategy to the operator in patients with acute coronary syndromes acute and submitted to cardiac catheterization.

NCT ID: NCT02193971 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial)

Start date: July 2014
Phase: Phase 4
Study type: Interventional

- Study objectives 1. To compare the safety and long-term efficacy of coronary stenting with biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome 2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention - Study design : Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients 1. Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of patient-oriented composite outcome 2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of major adverse cardiovascular events

NCT ID: NCT02175706 Active, not recruiting - Clinical trials for Coronary Artery Disease

DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity

DUTCHPEERS
Start date: November 2010
Phase: N/A
Study type: Interventional

Rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other. Objective: To investigate whether the clinical outcome is similar after implantation of the Promus Element versus the Resolute Integrity stent (non-inferiority hypothesis). Study design: Multicenter, prospective, randomized single-blinded study. Study population: Patients who require percutaneous coronary interventions (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. Intervention: In patients who are eligible for DES implantation, the type of DES implanted will be randomized (Resolute Integrity stent versus Promus Element stent). At the start of the study, both DES will also be used in routine clinical practice. Main study endpoints: The primary endpoint is the incidence of target vessel failure at one year follow-up. Target vessel failure (TVF) is a composite endpoint consisting of cardiac death, target vessel MI, or clinically driven target vessel revascularization. Further secondary clinical and angiographic endpoints will be investigated, defined in accordance with suggestions of the Academic Research Consortium (ARC). Of note, the angiographic assessment is based on clinically indicated projections only and results in no additional x-ray exposure. There is no routine angiographic follow-up. If angiographic data are available in patients who undergo symptom-driven re-catheterization, we will analyze these data to get insight into the mechanisms of potential DES restenosis. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the routine clinical treatment. As a consequence, the risks of this trial do not exceed the risks of any routine PCI procedure.

NCT ID: NCT02133287 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

To Evaluate The Safety and Efficacy of 'AVI' Stent Comparing With Firebird2® For Treating Coronary Revascularization

Start date: August 2013
Phase: N/A
Study type: Interventional

To evaluate The Safety and Efficacy of 'AVI' Stent Comparing with Firebird2® For Treating Coronary Revascularization.

NCT ID: NCT02061891 Active, not recruiting - Clinical trials for Coronary Artery Disease

Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes

VERDICT-EDI
Start date: November 2010
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate if acute invasive coronary evaluation and treatment conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred, subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an observational design the potential clinical benefit of coronary computed tomography angiography (CCTA) to select patients for invasive investigation and treatment in the two treatment arms (acute vs deferred) is evaluated. The following main hypothesis will be tested: - Very early invasive coronary investigation improves clinical outcome in patients with UAP/NSTEMI-ACS - CCTA performed before invasive coronary investigation will improve clinical management of patients with UAP/NSTEMI-ACS

NCT ID: NCT02015988 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

Start date: January 2014
Phase: Phase 4
Study type: Interventional

To test the hypothesis that early (within 5-21 days after index event) administration of combined lipid-lowering therapy in extremely high risk population of patients with type 2 diabetes mellitus (T2DM) and hypertriglyceridemia (HTG) who experienced acute coronary syndrome (ACS) will be effective and well tolerated in achievement of contemporary strict requirements for triglyceride (TG) levels as an independent risk factor in the case of HTG with diabetes.

NCT ID: NCT01918150 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Comparative Phase IV Study: Efficacy And Safety of TiTAN2 Versus COBALT-CHROME Stents- EVIDENCEII

EVIDENCE II
Start date: March 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effectiveness and safety, at 24 months, of the TITAN2 stent to any bare-metal stent (BMS) in Cobalt-Chromium in a population presenting an indication for these stents among 40% of which present an acute coronary syndrome (ACS).

NCT ID: NCT01838746 Active, not recruiting - Clinical trials for Coronary Artery Disease

CRAGS (Coronary aRtery diseAse in younG adultS)

CRAGS
Start date: April 2013
Phase: N/A
Study type: Observational

Young patients requiring myocardial revascularization are generally considered at low operative risk, but data on their immediate and late outcome are scarce. The decision-making process in these young patients is complicated by the potentially aggressive nature of premature coronary artery disease and their likely long expectancy of life, which expose them to a significantly higher risk of recurrent coronary events as well as the need of repeat revascularization. The lack of data on long-term outcome as well as on operative details (in particular, on the use of arterial grafts) and peri- and postoperative medication prevent any conclusive results on the durability either of coronary artery bypass grafting (CABG) or of percutaneous coronary intervention (PCI) in these young patients. Furthermore, recent advances in stents technology as well in peri- and postoperative medical treatment indicate the need a comparative study to define the baseline characteristics of patients aged < 50 years undergoing either PCI or CABG and to evaluate their current immediate and late outcome.

NCT ID: NCT01701453 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Safety of 6-month Duration of Dual Antiplatelet Therapy After Acute Coronary Syndromes (SMART-DATE)

SMART-DATE
Start date: August 2012
Phase: N/A
Study type: Interventional

1. Objective : To test the safety of 6 month-duration of dual antiplatelet therapy (DAPT) compared to conventional 12-month-or-longer duration after second-generation drug-eluting stent (DES) implantation in patients with acute coronary syndrome (ACS). 2. Hypothesis : A 6-month duration of DAPT is non-inferior to a conventional 12-month-or longer duration of DAPT at preventing the occurrence of major adverse cardiac and cerebrovascular events (MACCE) at 18-month after second-generation DES implantation in patients with ACS.