Active clinical trials for "Dyslipidemias"

High-intensity statins are recommended for secondary prevention of stroke in patients with atherosclerotic ischemic stroke. According to the guidelines of the American Heart Association and the American Stroke Society, high-intensity or high-dose statins are recommended for high-risk groups of atherosclerotic cardiovascular disease (ASCVD). Statin therapy is recommended even if it is less than 100 mg/dL. The 2016 ESC/EAS and 2017 AACE guidelines include ischemic stroke and transient cerebral ischemic attacks caused by atherosclerosis in ASCVD, classifying them as ultra-high-risk groups, and recommending LDL cholesterol of less than 70 mg/dL as a treatment goal. The recently published guidelines for dyslipidemia in Korea also recommend that the target level of LDL cholesterol in patients with atherosclerotic ischemic stroke and transient ischemic attack be reduced to less than 70 mg/dL or 50% or more from the baseline. According to a previous study on the efficacy and safety of high-intensity rosuvastatin in patients with ischemic stroke, it is not clear whether the use of rosuvastatin 20 mg prevents recurrence of cerebral infarction in the acute stage, but it is safe and effective for hemorrhagic conversion of cerebral infarction. In addition, the results were shown when rosuvastatin and ezetimibe were combined in patients with high cardiovascular risk, LDL cholesterol and total cholesterol decreased more in the combined group than in the single agent group. In a study comparing the group whose LDL cholesterol target was reduced to 70 mg/dL or less after stroke and the group maintained at 90-110 mg/dL, the group whose LDL cholesterol was controlled to 70 mg/dL or less It was confirmed that the incidence of cardiovascular disease was reduced. Existing studies aimed at general high-risk groups, not specific disease groups, and as in this study, studies were not conducted on a single disease group called acute stroke. In addition, there are only limited studies on the effectiveness and safety of diseases that occur mainly in the elderly, such as acute stroke. Therefore, there are currently no studies on the clinical efficacy and safety of high-intensity rosuvastatin and ezetimibe combination therapy for patients with acute cerebral infarction.

The purpose of this study is to evaluate the efficacy and safety of AD-218

Atherosclerosis in the setting of HIV infection is distinct and includes increased vascular inflammation, worsened endothelial function, and a predominance of non-calcified plaque. These outcomes can be assessed using specialized noninvasive imaging which strongly predict future CV events in the general population. PCSK9 has emerged as an important pharmacologic target for cholesterol lowering in the general population and recent studies among individuals without HIV have shown that PCSK9 inhibitor therapy is safely tolerated and significantly reduces major CV events in the general population. The investigators will perform a clinical trial of PCSK9 inhibition in the setting of HIV infection. This will be a randomized, placebo-controlled study to evaluate the effects of PCSK9 inhibition on vascular inflammation, endothelial function, and non-calcified plaque using a PCSK9 inhibitor called alirocumab. This study will recruit 140 treated individuals with HIV who are aged 40 and older, with known CVD or risk factors for CVD and who have evidence of vascular inflammation at baseline. The primary and secondary objective of this study is to determine whether PCSK9 inhibition can improve arterial inflammation as assessed by FDG-PET/CT and endothelial function as assessed by flow mediated vasodilation. The investigators will correlate changes in arterial inflammation and endothelial function with lipids and markers of inflammation and immune activation. The tertiary objective is to perform a pilot evaluation of the impact of PCSK9 inhibition on non-calcified plaque as measured by coronary CT angiography. Non-calcified plaque measurements will be correlated with changes in lipid parameters and markers of inflammation and immune activation.

Hardening of the blood vessels, called arterial stiffness, is a risk factor for future heart disease and its causes are unclear. The proposed study will 1) randomly assign adolescents at high risk of stiffening blood vessels to take a protein supplement called carnitine and study its effects on arterial stiffening and 2) study carnitine related genes for their effect on arterial stiffening. The study will definitively establish a role for carnitine action as a cause of stiffening blood vessels and signal a way to treat or prevent stiffening.

Rationale: Patients with acute coronary syndromes are at an increased risk for recurrent adverse coronary events, particularly during the early period following their initial presentation. Early (in-hospital) initiation of high-intensity statins reduces the risk of recurrent events and is therefore recommended by the best current practice guidelines.(1,2) However, the delayed onset of action of statin therapy and given the frequent failure of patients to achieve the recommended LDL-C targets using statins alone (as per the current practice guidelines recommendations), might be placing large number of patients at increased risk during such a vulnerable period early after an ACS.(3) More rapid and effective reduction of LDL-C levels using combination therapy from the outset may therefore be beneficial in these patients. This hypothesis has been tested with combining Evolocumab and a statin in the recent EVOPACS study, in which this combination after ACS has shown to be safe and more effective in achieving LDL-C targets at 6 weeks compared to statin monotherapy.(4) However, Evolocumab (a PCSK9i) is an expensive drug which is not affordable by many healthcare systems in low- and middle-income countries. Ezetemibe, on the other hand, is a safe and a cheap drug that can prove to be extremely cost-effective if a meaningful and timely reduction in LDL-C levels can be achieved when combined with a statin early after an ACS. Study population Patients presenting with acute myocardial infarction, with baseline LDL-C levels not likely to achieve recommended targets on statin monotherapy. This is assumed to be with LDL-C level > 125 mg/dl for those not on lipid lowering therapy; or with LDL-C > 100 mg/dl on moderate intensity statin therapy at the time of presentation. Study design Prospective randomized controlled single-blinded trial. A sample size of 500 patients, 250 in each arm, was calculated to provide a power of 0.9 and an adjusted type 1 error as 0.05. Primary outcomes Percentage of patients achieving target LDL-C levels (<70 mg/dl) at 6 weeks interval. (Efficacy endpoint) Freedom from alanine transaminase elevation (ALT) more than 3 folds upper reference limit "URL" or statin associated muscle symptoms associated with CK elevation more than 4 folds URL. (Safety endpoint) Secondary outcomes Percentage of patients achieving > 50% reduction of LDL-C and to levels below 70mg/dl at 6 weeks interval. Percentage of LDL-C reduction at 6 weeks interval. Reduction of high-sensitive C-reactive protein (hs-CRP) from baseline to 6 weeks interval. Correlating statins efficacy to reduce LDL-C and likelihood to cause statins related adverse effects to genetic alleles of ABC [ATP Binding Cassette] types A1, G5 and G8, and of CYP450 isoenzymes. MACE free survival at 1 year, (CV death; non fatal-MI; hospitalization for ACS, urgent unplanned revascularization and stroke).

Almost all antipsychotics can induce dyslipidemia, but no treatment has been established. Vildagliptin can improve lipid levels in obese patients. The investigators conducted a randomized, placebo-controlled study to test the efficacy of vildagliptin for antipsychotic-induced dyslipidemia.

Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.

To study the efficacy and safety of pitavastatin and PCSK9 inhibitors in liver transplant patients on ongoing immunosuppressive therapy.

In this project, the investigators will perform a multicenter randomised controlled trial to determine whether advice to consume a moderate, whole food-based low-carbohydrate high-fat (LCHF) ad libitum diet (CarbCount program) can produce and maintain equal remission rates of type 2 diabetes (T2D) as a nutritionally complete very-low-calorie formula diet followed by a energy-restrictive (i.e., calorie counting) diet (DiRECT principles). Within the principles of each approach, the dietary goals and change will be adjusted according to individual needs/capabilities conducive to long-term adherence. Furthermore, the investigators aim to determine whether the rate of diet-induced remission is reflected in/can be predicted by baseline or diet-induced changes in glucose variability (e.g., time-in-range measured by continuous glucose monitoring) and other factors such as anthropometric changes and genetic susceptibility. Each center will also conduct locally-lead standalone mechanistic research, including analyses of intra-abdominal/hepatic fat accumulation, adipose tissue biopsies and/or measurements of energy metabolism. Additionally, changes in medication use, nutritional status, cardiovascular disease risk, as well as adverse events, will be monitored.

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.