A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese...
Healthy VolunteersAtherosclerotic Cardiovascular DiseaseThe aim of this study is to look at how the study medicine works in the body and how it is removed from the body. We are testing the study medicine to make a medicine that can help people lower their cholesterol level. Participants will either get NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg. placebo (a dummy medicine which looks like the study medicine but without any medicine). Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation). Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days. Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7). At all visits, except the information visit, participants will have blood drawn along with other clinical checks. Participants will be asked about their health, medical history and habits including mental health.
Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac...
AngioplastyPeripheral Arterial Disease3 moreThe objective of this prospective, multicenter, non-randomized, single-arm observational study is to evaluate the efficacy and the safety of the iCover covered stent for the treatment of de novo aorto-iliac atherosclerotic lesions in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).
Cardio-Metabolic Risk Evaluation in Overweight and Obese Children
Pediatric ObesityMetabolic Syndrome4 moreMetabolic and cardio-vascular complications can often appear in overweight and obese children from an early age. Currently, there are few studies in the specialized literature that correlate clinical, biological and ultrasound parameters in order to stratify cardio-metabolic risk in obese children. Also, the specialized literature is poor regarding longitudinal follow-up and the importance of diet for reducing metabolic and cardiovascular complications in these children. This study is designed to assess the hypothesis that the sustained improvement of lifestyle with regard to nutrition and exercise can reverse cardiometabolic multimorbidities in obese children as assessed by clinical, biological and ultrasound evaluation.
Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis
Ischemic StrokeCurrently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and preliminary clinical experiments show that head-down position may significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke
Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the...
AtherosclerosisThis is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Doses of Darapladib...
AtherosclerosisIn accordance with the recently revised FDA draft renal impairment guidance (March 2010) which advises the conduct of renal impairment study in drugs that are not predominately eliminated through the renal route, the proposed study will be conducted to formally assess the pharmacokinetics (PK) of darapladib in severely renally impaired subjects. In this is an open-label, non-randomized study eight subjects with severe renal impairment will be recruited along with 8 healthy control subjects matched to the severe renal impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or minus 10 years). All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10 consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and tolerability will be evaluated. All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check out of the clinic on Day 2 after all assessments are complete, but must return to the clinic each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic again on the evening of Day 9. After the last dose of the study drug, there will be a follow-up period which will include 2 visits (Day 20-24 and Day 38-52). The total study duration for each subject including the screening, treatment and follow-up periods will be approximately 11 weeks.
The XLIMUS-DES in Very Complex Lesions
Coronary Atherosclerosis Due to Calcified Coronary LesionChronic Total Occlusion of Coronary ArteryStent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and >90% of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses characterised by better mechanical properties than traditional DES. This is a prospective, non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS DES in severely complex coronary lesions in real-world clinical practice.
Pharmacokinetics & Safety Study of Clopidogrel 75mg and Aspirin 100mg Coadministration
AtherosclerosisThe purpose of this study is to compare characteristics and safety after oral administration of G0041(75/100mg) 2 tablets with those of Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules coadministration in healthy male volunteers.
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
AtherosclerosisAtherosclerotic disease, or hardening of the arteries, is characterized by the thickening of the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries. High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role in developing clinical symptoms of atherosclerosis disease. The complications of advanced atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack, stroke and/or death and blockage of arteries. This study is being done to assess the effectiveness of Spironolactone therapy to slow down the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of your aortic wall. Spironolactone is an FDA approved drug used to treat heart failure and in the management of hypertension (high blood pressure), but in this study it is used for another unapproved reason. In this study, we would like to evaluate the effects of Spironolactone in people with diabetes and atherosclerotic disease.
Everolimus Stent in Patients With Coronary Artery Disease (CAD)
Coronary Artery DiseaseCoronary AtherosclerosisAim of the study is to compare the everolimus eluting stent and sirolimus eluting stent in all comers PCI eligible patients