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Coronary Artery Disease clinical trials

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NCT ID: NCT03737565 Not yet recruiting - Clinical trials for Coronary Artery Disease

Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm)

RETO 320
Start date: January 15, 2019
Phase:
Study type: Observational [Patient Registry]

This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.

NCT ID: NCT03736018 Not yet recruiting - Clinical trials for Contrast-induced Nephropathy

Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients

BYPASS-CTCA
Start date: November 8, 2018
Phase: N/A
Study type: Interventional

A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive coronary angiography. Invasive coronary procedures in patients with bypass grafts can be more complicated due to the variation in bypass graft ostia. This can lead to longer procedure times, with higher doses of contrast and radiation and more discomfort for the patient. The aim of this study is to see if the use of computed tomography cardiac angiography (CTCA) in patients with previous bypass grafts prior to invasive coronary angiography will help make their procedure safer and quicker.

NCT ID: NCT03730116 Not yet recruiting - Clinical trials for Arterial Hypertension

Assessment of the Efficacy and Tolerability of the Fixed-dose Combination of Bisoprolol/Perindopril in Patients With Arterial Hypertension and Stable CAD in Daily Clinical Practice

STYLE
Start date: November 10, 2018
Phase:
Study type: Observational

Study objective - to assess the efficacy, tolerability and adherence of bisoprolol/perindopril FDC in patients with HT and stable CAD in everyday practice. Type of the program: multicenter, observational, uncontrolled, open program. The program will involve 480 general practitioners (GPs) and cardiologists from the primary care facilities.Each doctor includes four patients. It is planned to include not less than 1920 patients in total.

NCT ID: NCT03729739 Not yet recruiting - Clinical trials for Coronary Artery Disease

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study

FAVOR III EJ
Start date: November 2, 2018
Phase: N/A
Study type: Interventional

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

NCT ID: NCT03729401 Not yet recruiting - Clinical trials for Coronary Artery Disease

Personalization of Long-Term Antiplatelet Therapy

RAPID EXTEND 2
Start date: November 2018
Phase: Phase 4
Study type: Interventional

In patients after myocardial infarction (MI) (heart attacks) and treated with percutaneous coronary intervention (PCI), the current standard is dual antiplatelet therapy (DAPT), with aspirin and a P2Y12 receptor inhibitor, for 1 year of treatment. At 1 year, there are several options including: i) Ongoing DAPT (with aspirin and ticagrelor), ii) Selective treatment use of a P2Y12 inhibitor based on risk profiles. This study is a pilot vanguard study to evaluate several strategies for choosing anti-platelet regimen among patients post MI and PCI at 1 year.

NCT ID: NCT03728127 Not yet recruiting - Clinical trials for Coronary Artery Disease

Brazilian Cardioprotective Diet and Nuts in Post-acute Myocardial Infarction

DICA-NUTS
Start date: November 2018
Phase: N/A
Study type: Interventional

Coronary artery disease (CAD) is the leading cause of death worldwide. Dietary patterns and functional foods may play an important role in the management of cardiovascular risk factors such as overweight and dyslipidemia, as well as inflammation and oxidative stress. However, little is known regarding the effect of diets or specific nutrients on these parameters in individuals with acute myocardial infarction (AMI). The Brazilian Cardioprotective Diet (DicaBr) is based on Brazilian nutritional guidelines and also in a unique and ludic nutritional strategy. In a pilot study, this diet was effective in reducing blood pressure (intragroup comparison) and body weight (intergroup comparison) in individuals with established cardiovascular disease (CVD). However, the effectiveness of this dietary pattern supplemented with different kind of nuts is unknown. The aim of this study is to evaluate the effect of the DicaBr supplemented or not with 30g/day of different nuts on cardiometabolic parameters in patients with recent AMI. In this parallel randomized controlled trial, 600 patients ≥40 years with a recent diagnosis of AMI (60 to 180 days) will be allocated to one of two study groups: 1) DicaBr group (DCB, control group); or 2) DicaBr group supplemented with nuts (DCBN, intervention group). All patients will receive the same dietary prescription, the DCBN group also will receive 30g/day of nuts, according to the different regions of the country (South region: peanuts; Central-West and Northeast regions: cashew nut and Brazilian nut). The primary outcome will be LDL-cholesterol (LDL-c) levels after 16 weeks. In the baseline and at the end of the study (16 weeks), lipid and glycemic profile and anthropometric indexes will be evaluated in both groups; inflammatory and oxidative stress markers, and adipokines will be evaluated in a subsample. It is expected that DicaBr supplemented with nuts will be superior to DicaBr alone to benefit patients with AMI regarding cardiometabolic parameters.

NCT ID: NCT03726892 Not yet recruiting - Clinical trials for Coronary Artery Disease

Comparison of MECHANISM of Early and Late Vascular Responses Following Treatment of ST-elevation Acute Myocardial Infarction With Two Different Everolimus-eluting Stents: Randomized Controlled Trial Between Biodegradable Polymer and Durable Polymer Stent (MECHANISM-AMI-RCT)

Start date: November 2018
Phase: N/A
Study type: Interventional

To place two different everolimus-eluting stents (EES), a bioabsorbable polymer EES (Synergy®) and a permanent-type polymer EES (Xience®), randomly to the ST-elevation acute myocardial infarction (AMI) and to observe and compare the early and chronic vascular responses using the frequency domain optical coherence tomography (FD-OCT). The primary endpoint is the 2-week strut coverage rate by FD-OCT.

NCT ID: NCT03721614 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Study Comparing Single Long BioMimeTM Morph Coronary Stent System vs. Two Overlapping Xience Family Coronary Stent Systems in the Treatment of Patients With Long de Novo Lesions.

Morph RCT-1
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

A prospective, active control, open-label, multinational, randomized clinical trial comparing single long BioMime™ Morph Coronary Stent System vs. two overlapping Xience family Coronary Stent Systems to evaluate safety and performance in approximately 200 patients with long de novo lesions will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)]. The study population should include patients with symptomatic ischemic heart disease due to de novo lesions (lengths ≥26 mm and ≤56 mm irrespective of number of lesions) in native coronary arteries with a reference vessel diameter of (proximal to distal) 2.75 - 2.25 mm, 3.00 - 2.50 mm and 3.5 - 3.00 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and stenting procedures. All patients must meet all the study inclusion / exclusion criteria before enrolment in the study. All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 24 months post procedure. 10% of the patients [(2:1) BioMime™ Morph (13) vs. Xience (7)] will be assessed for OCT analysis from pre-designated site(s) and based on availability of OCT console at the site and Patient's consent. [Time Frame: Post-procedure and 6 months (±14 days)]

NCT ID: NCT03718559 Not yet recruiting - Clinical trials for Coronary Artery Disease

Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease

EPIC-CAD
Start date: December 20, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD [≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).

NCT ID: NCT03718429 Not yet recruiting - Clinical trials for Coronary Artery Disease

Pharmacodynamic Effects of Low-dose Rivaroxaban With Antiplatelet Therapies

Start date: December 2018
Phase: Phase 4
Study type: Interventional

Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. To date there is very little data, and not conducted in human subjects, on the interplay between anti-Xa blockade with low-dose rivaroxaban and antiplatelet therapies, and in particular how this affects profiles of platelet reactivity and thrombin generation. Given the potential role for the use of low-dose rivaroxaban for the prevention of ischemic recurrences in patients with atherothrombotic disease manifestations, including coronary artery disease (CAD) and peripheral arterial disease (PAD), the study team proposes a prospective pharmacodynamic (PD) investigation assessing the impact of low-dose rivaroxaban when used in combination with antiplatelet treatment regimens commonly used in clinical practice.