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Angina, Unstable clinical trials

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NCT ID: NCT02618837 Active, not recruiting - Clinical trials for Unstable Angina or Non ST Elevated Myocardial Infarction

Downstream Versus Upstream Strategy for the Administration of P2Y12 Receptor Blockers

DUBIUS
Start date: December 14, 2015
Phase: Phase 4
Study type: Interventional

To evaluate the impact on outcomes of the currently accepted antithrombotic strategies based on the administration of newer P2Y12 receptor blockers (prasugrel and ticagrelor) in a population of non ST elevated ACS (NSTEACS) patients with an initial invasive indication. Furthermore, to evaluate the effects of bivalirudin administration in comparison to standard therapy with unfractioned heparin (plus provisional anti-GPIIbIIIa) in NSTEACSpatients who undergo PCI and will thus receive these potent antiplatelet agents which may theoretically favor the occurrence of bleedings. A combined measure of efficacy and safety endpoints, the so-called net clinical benefit (NACE), will be considered at early (30 days) and mid term (12 months) follow-up.

NCT ID: NCT02594501 Active, not recruiting - Angina, Unstable Clinical Trials

Randomized Trial of COBRA PzF Stenting to Reduce Duration of Triple Therapy

COBRA-REDUCE
Start date: February 5, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

NCT ID: NCT02508714 Active, not recruiting - Clinical trials for Coronary Artery Disease

Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

BIONYX
Start date: October 7, 2016
Phase: N/A
Study type: Interventional

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

NCT ID: NCT02468960 Active, not recruiting - Clinical trials for Coronary Artery Disease

Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)

Start date: March 2015
Phase: N/A
Study type: Interventional

Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold). Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.

NCT ID: NCT02317198 Active, not recruiting - Unstable Angina Clinical Trials

Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly

POPular AGE
Start date: June 2013
Phase: Phase 4
Study type: Interventional

A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will be followed for one year for outcomes such as bleeding episode requiring medical intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding).

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: NCT02131142 Active, not recruiting - Clinical trials for Ischemic Heart Disease

BioFreedom US IDE Feasibility Trial

Start date: August 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and effectiveness data for on the Biosensors BioFreedomâ„¢ BA9 Drug Coated Coronary Stent in patients with native, de novo coronary artery disease.

NCT ID: NCT02062021 Active, not recruiting - Stroke Clinical Trials

Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease

Start date: January 2014
Phase: N/A
Study type: Observational

Autoimmune diseases are diseases in which inappropriate immune responses that have the capability of harming host cells play an important role. Evidence suggests that the presence of certain autoimmune diseases such as rheumatoid arthritis or systematic lupus erythematosus increase the risk of cardiovascular disease (CVD). However, this evidence is inconsistent for autoimmune disorders and no systematic approach has been previously used to study the relationship between a range of common autoimmune disorders and specific forms of cardiovascular diseases such as myocardial infarction, intracerebral and subarachnoid haemorrhage, or venous thrombosis. The investigators will use linked electronic health records to investigate whether commonly diagnosed autoimmune disorders are associated with increased risk of CVD development and whether effects differ in men and women and change with age.

NCT ID: NCT01947361 Active, not recruiting - Stroke Clinical Trials

Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

Start date: January 2012
Phase: N/A
Study type: Observational

Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.

NCT ID: NCT01937065 Active, not recruiting - Stroke Clinical Trials

Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study

IP4
Start date: January 2012
Phase: N/A
Study type: Observational

Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.