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Showing 1-20 of 55 trials
NCT07654231
The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care. Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.
NCT05485961
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study. Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
NCT07615296
The goal of this clinical trial is to learn whether an ultra-low LDL-C target (\<1.0 mmol/L) can improve clinical outcomes compared with a moderately low LDL-C target (1.0-1.39 mmol/L) in Chinese patients with extreme-high-risk atherosclerotic cardiovascular disease (ASCVD). It also aims to evaluate long-term safety and cost-effectiveness, and explore potential benefit subgroups and underlying mechanisms. The main questions it aims to answer are: Does an LDL-C target \<1.0 mmol/L reduce major adverse cardiovascular events (MACE-4: cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, urgent coronary revascularization) compared with a target of 1.0-1.39 mmol/L?What are the long-term safety risks including cognitive decline, hemorrhagic stroke, new-onset diabetes, new malignancies and severe adverse drug reactions under different LDL-C targets?Researchers will compare participants receiving an LDL-C target \<1.0 mmol/L with those receiving a target of 1.0-1.39 mmol/L to see if the ultra-low LDL-C strategy provides better clinical benefit with acceptable safety and economic value. Participants will: Receive lipid-lowering therapy following a mandatory titration-maintenance-off-target correction algorithm according to their assigned LDL-C target Undergo routine follow-up every 3 months, cognitive assessment every 6 months, and comprehensive annual re-examinations for a median of 2 years and up to 5 years Have centralized blinded lipid testing and endpoint adjudication by an independent Clinical Event Committee
NCT07543731
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
NCT07355894
This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults. The study uses artificial intelligence to detect calcium buildup in heart arteries (coronary artery calcium or CAC) on chest CT scans that patients have already had for other reasons. The study will focus on adults who either have known atherosclerotic cardiovascular disease (ASCVD) or have significant calcium buildup (a CAC score of 100 or higher), and whose cholesterol is not well controlled. It will also evaluate how well this approach can be implemented at scale across multiple health systems. The main questions it aims to answer are: Does notifying patients and their clinicians about incidental CAC increase lipid-lowering therapy(LLT) initiation or intensification? Does the intervention improve Low-Density Lipoprotein(LDL)-cholesterol control and related lipid testing? How does the intervention affect downstream care (e.g., clinic visits, cardiology referrals, and cardiac testing)? Researchers will use an FDA-cleared AI algorithm to quantify CAC on previously performed non-gated chest CT scans and identify eligible participants through the electronic health record. Participants will be randomized to receive CAC notification either right away or after a 6-month delay.
NCT06292013
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.
NCT05739383
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
NCT07487363
This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1/2 trial evaluating the safety and tolerability of TB-500 (a 17-23 fragment of thymosin beta 4) versus placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Exploratory endpoints assess vascular function and inflammation biomarkers
NCT06813911
The purpose of the study CTQJ230A12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo in participants with ASCVD who have elevated lipoprotein(a) (Lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (LDL-C).
NCT06295679
The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.
NCT06930885
The EPOCA study (Evaluation of a POlypill and Colchicine for risk reduction in patients with established Atherosclerotic cardiovascular disease) will be a randomized, superiority, parallel, 2x2 factorial, multicenter clinical trial which will include at least 7713 and up to a maximum of 10797 participants with established atherosclerotic cardiovascular disease.
NCT07311330
This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction
NCT07309042
The primary objective of this study is to investigate the safety and tolerability of YN001 in combination with rosuvastatin, so as to provide evidence for the feasibility of YN001 combined with statins in subsequent clinical trials.
NCT06424860
Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.
NCT03705234
ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU\_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.
NCT04626973
Although the clinical efficacy of LDL-cholesterol lowering therapy has been proven with strong evidences and emphasized, there are also growing concerns that intensive lipid-lowering therapy would be related to increased risk of adverse effects. In addition, statin potency from recent guidelines was set from the studies composed of mainly Caucasian population, although there is an inconsistency of statin effect according to ethnicity. Asian population showed more profound LDL reduction not only from high potent statin but also from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate LDL-cholesterol levels. Adding ezetimibe will be an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to achieve sufficient LDL-cholesterol lowering effect. However, studies regarding the effect of intensive-targeting of lipid-lowering therapy and therapy regimens are lacking. Thus, on these basis, we sought to evaluate whether intensive-targeting of lipid-lowering therapy will have more prominent beneficial effect compared to conventional-targeting in patients with documented ASCVD with either an ezetimibe/statin combination therapy or a statin monotherapy.
NCT07203677
Investigators are building an empirical evidence base for real world data through large-scale emulation of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
NCT05720156
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also have pleiotropic effects on inflammation. The immunomodulatory effects of these medications are relevant to ASCVD risk reduction given that inflammation plays a central role in atherosclerotic plaque formation (atherogenesis) and influences the development of vulnerable plaque morphology. Patients on statins, however, may have residual inflammation contributing to incident ASCVD despite the potent LDL-lowering effects of statins. While new therapies, such as proprotein convertase subtilisin/kexin type 9 (PSCK9) inhibitors, further reduce incident ASCVD and drastically reduce LDL-C below that achieved by statin therapy alone, PCSK9 inhibitors may also have pleiotropic effects on inflammation. Thus, PCSK9 inhibitors may help reduce arterial inflammation to a level closer to that of patients without ASCVD. This study will apply a novel targeted molecular imaging approach, technetium 99m (99mTc)-tilmanocept SPECT/CT, to determine if residual macrophage-specific arterial inflammation is present with statin therapy and the immunomodulatory effects of PSCK9 inhibition. Given the continued high mortality and morbidity attributable to ASCVD, strong imperatives exist to better understand the immunomodulatory effects of lipid lowering therapies and residual inflammatory risk. This understanding, in turn, will inform the development of new ASCVD preventative and treatment strategies as well as elucidate other indications for established therapies.
NCT06962488
In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention.
NCT06858332
This study has the purpose to answer how the Lipoprotein(a) (Lp(a)) level is distributed among Atherosclerotic cardiovascular disease (ASCVD) patients in Russia, and what is the connection between elevated levels of this parameter and the cardiovascular disease (CVD) risk.