Active clinical trials for "Hypercholesterolemia"

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

JS002 is a recombinant human anti-PCSK9 monoclonal antibody.The study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study in Chinese patients with heterozygous familial hypercholesterolemia (HeFH). Objective To evaluate the efficacy and safety of JS002 150 mg (Q2W) and 450 mg (Q4W) subcutaneous injection (SC).

The primary objective of the study is to compare the plasma pharmacokinetics (PK) of MK-0616 following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease [ESRD]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.

Hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (CVD). Treatment with lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors or LDL-apheresis) reduces the risk of major cardiovascular events in proportion to the absolute reduction of LDL-cholesterol (LDL-C). Nevertheless, a better understanding of the effects of hypercholesterolemia on the cardiovascular and immune systems could help identify all the mechanisms responsible for the excess risk of CVD in hypercholesterolemic patients and develop better prevention and treatment strategies. Adenosine via A2A receptors (A2AR) plays a crucial role in the regulation of the cardiovascular and immune systems. In this project, the investigators wish : To study whether the expression and function of A2AR in PBMCs are altered in human hypercholesterolemia, using as a study model a larger cohort of patients with hypercholesterolemia of increasing level and severity: polygenic form, heterozygous genetic form and homozygous genetic form in comparison with healthy subjects with normal cholesterol levels. To study whether A2AR expression and function in PBMCs are associated with blood levels of LDL-C and homocysteine and with the inflammatory status of patients. To assess whether the cholesterol-lowering therapies currently used to reduce LDL-C levels and thus the risk of CVD in hypercholesterolemic patients have an impact on possible alterations of A2AR expression and function in PBMCs.

ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact patient care and outcomes. The study will recruit patients admitted to hospital with an acute coronary syndrome, and research-based genetic testing will be conducted for known FH-causing genetic variants. The results will be returned to the patients' treating physicians. The primary endpoint will be the number of patients with a new diagnosis of FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL cholesterol level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 12 months after the index acute coronary syndrome.

The main objective of this clinical trial is to evaluate whether the antiplatelet efficacy of the Dengzhanxixin capsule is better than that of placebo in individuals at high-risk for atherosclerotic cardiovascular disease (ASCVD).

The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W [<31 days]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with >1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be ~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

Comparison of LDL-C reductions of lerodalcibep (LIB003) 300 mg to inclisiran (Leqvio®) 284 in patients at very-high risk or high-risk for CVD on stable diet and oral LDL-C-lowering drug therapy

An important aspect of successful genomic medicine implementation is developing effective approaches for screening at-risk family members after probands are identified, also known as cascade screening. Most cascade screening studies conducted to date have been conducted outside the US, and very few studies have used a rigorous approach involving a comparator group or randomized controlled design. A major question in the field is how to most effectively implement cascade screening, given commonly cited communication barriers, while respecting privacy among probands and family members. This study will conduct a randomized controlled trial to assess direct contact of relatives by study team members vs indirect, or proband-initiated, contact. We will assess efficacy of the cascade screening intervention, patient-centered outcomes regarding mental, physical, and psychosocial outcomes in probands and family members, and implementation evaluation outcomes. Individuals who are known to carry the KCNQ1 Met224Thr or APOB Arg3527Gln variant will be eligible to participate. After providing consent and being deemed eligible, individuals will be randomized in a 1:1 manner into the direct or indirect contact of family members arm of the study. The randomization will be stratified by variant to ensure equal representation of each variant in the study arms. Individuals in the indirect arm will be instructed to contact their first-degree family members about the opportunity to be screened. They will be provided with a disease-specific pamphlet and a family letter explaining the cascade screening. In the direct arm, probands will be advised that the study staff will be contacting their family members. They will be instructed to also contact their family members prior to the study team contacting them. Approximately two weeks after this meeting with the proband, the study staff will mail letters to eligible first-degree family members of the probands. If we do not hear back from individual family members, we will follow-up with another letter, telephone call, or home visit. The information contained in the letters will be the same information for both the direct and indirect arms of the study. All interested family members will receive pre-test counseling and free, in-home, saliva-based genetic testing, and post-test counseling.