Clinical trials: PCSK9 Inhibitor
Locally Advanced Rectal Cancer
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer
This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS…
- Trial name
- NCT06304987
- Testing
- Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor, Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Beijing Friendship Hospital
Stroke, Acute Ischemic, PCSK9 Inhibitor
The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile
The goal of this clinical trial is to test the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors) in acute ischemic stroke patients associated with atherosclerosis by investigating 1.
- Trial name
- NCT06083961
- Testing
- Alirocumab
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Sun U. Kwon
Hypercholesterolemia
A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn)
The main purpose of this study is to assess whether enlicitide is superior to ezetimibe or bempedoic acid or ezetimibe + bempedoic acid in reducing low-density lipoprotein cholesterol (LDL-C) in participants with…
- Trial name
- NCT06450366
- Testing
- Enlicitide, Ezetimibe, Bempedoic Acid
- Where
- 35 sites in United States, Argentina and 6 more
- Volunteers
- 301 people
- Sponsor
- Merck Sharp & Dohme LLC
Hyperlipidemia
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol…
- Trial name
- GAUSS-2 (NCT01763905)
- Testing
- Evolocumab, Ezetimibe
- Where
- 58 sites in United States, Australia and 12 more
- Volunteers
- 307 people
- Sponsor
- Amgen
Hyperlipidemias
Lipid Management in Renal Transplant Recipients Using Evolocumab.
Cardiovascular disease is the leading cause of mortality after renal transplantation, accounting for more than 30% of deaths. Elevated lipid levels (hyperlipidemia) are a frequent finding following transplantation and the…
- Trial name
- NCT04608474
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Brigham and Women's Hospital
NSCLC (Advanced Non-small Cell Lung Cancer), Resistance to Immunotherapy
PD-1 Combined With Bevacizumab and PCSK-9 Inhibitor in Patients With Advanced NSCLC Who Have Progressed After Anti- PD- 1/L1 Therapy
This study evaluated the sintilimab combination of bevacizumab and tafolecimab in NSCLC patients who have previously been treated with anti- PD- 1/ligand (L)1 and acquired resistance.
- Trial name
- NCT07014215
- Testing
- Sintilimab combined with Bevacizumab and tafolecimab
- Volunteers
- 52 people
- Sponsor
- Anhui Provincial Cancer Hospital
Non-Small Cell Lung Cancer (NSCLC), Hyperlipidemia
Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC
For Patients and Families Brief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC What is this study about? This study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Hyperlipidemia, ALK Gene Mutation, ALK-positive
- Trial name
- NCT07674524
- Testing
- For Part A - Observational Cohort:, Part B: Intensive Lipid-Lowering Group, For Part B - Intensive Group
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-sen University
Carotid Artery Stenosis
A Cohort Study Comparing PCSK9 Inhibitor Plus Statin With Statin Monotherapy for Carotid Artery Stenosis
A multicenter cohort study
- Trial name
- TRIP-CAS (NCT07036991)
- Testing
- PCSK9 inhibitor (biweekly injections) + Rosuvastatin/Atorvastatin ± Ezetimibe, Rosuvastatin/Atorvastatin ± Ezetimibe
- Where
- China
- Volunteers
- 406 people
- Sponsor
- Changhai Hospital
Acute Stroke
Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke
This study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design).
- Trial name
- EPOCH-LYSIS (NCT07301372)
- Testing
- Ivolumab 420mg (three vials)
- Where
- China
- Volunteers
- 132 people
- Sponsor
- The Affiliated Hospital of Xuzhou Medical University
HIV Seropositivity, Dyslipidemias
COPANA - A09 PCSK 9 Substudy: Impact of Protease Inhibitors on PCSK9 Levels in Naive HIV-Infected Patients
Evaluation of the impact of initiation of protease inhibitor/ritonavir on PCSK9 levels in HIV-infected antiretroviral-naïve patients from the ANRS C09 COPANA cohort.
- Conditions
- HIV Seropositivity, Dyslipidemias, PCSK9
- Trial name
- COPANA (NCT03139630)
- Where
- France
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Franck Boccara
Hyperlipidemia
Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals
This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization.
- Trial name
- NCT07712042
- Testing
- Tafolecimab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Mei Gao
Atherosclerotic Cardiovascular Disease, Older Patients
LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)
To determine whether treating to an LDL-C target of 25 to <70 mg/dL is superior to an LDL-C target of 70 to <100 mg/dL with respect to major cardiovascular events (cardiovascular death, myocardial infarction, stroke…
- Conditions
- Atherosclerotic Cardiovascular Disease, Older Patients, LDL Cholesterol
- Trial name
- NCT05765370
- Testing
- Achieving a Target LDL-C level of 25mg/dL≤ LDL-C<70mg/dL, Achieving a Target LDL-C level of 70mg/dL≤ LDL-C<100mg/dL
- Where
- China
- Volunteers
- 4,200 people
- Sponsor
- China National Center for Cardiovascular Diseases
Non-small Cell Lung Cancer (NSCLC)
PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung
PCSK9 mediates immune checkpoint blockade resistance by downregulating tumor cell surface MHC class 1 molecules. This study will evaluate if combining the anti-PCSK9 antibody alirocumab with the anti-PD-1 antibody cemiplimab can…
- Trial name
- NCT05553834
- Testing
- Alirocumab and Cemiplimab
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Cardiovascular Diseases, Hyper-LDL-cholesterolemia
Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable…
- Trial name
- LIBerate-CVD (NCT04797247)
- Testing
- lerodalcibep
- Where
- 3 sites in United States
- Volunteers
- 900 people
- Sponsor
- LIB Therapeutics LLC
Adverse Effect of Cardiovascular Medications (Diagnosis)
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography…
- Trial name
- NCT05802108
- Testing
- Evolocumab combined with statins, Statin
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Zibo Central Hospital
Hereditary Spastic Paraplegia Type 5
PCSK9 Inhibitor Treatment for Patients With SPG5
Spastic paraplegia type 5 (SPG5) is a rare subtype of hereditary spastic paraplegia, a highly heterogeneous group of neurodegenerative disorders defined by progressive neurodegeneration of the corticospinal tract motor neurons.
- Trial name
- NCT04101643
- Testing
- evolocumab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Fujian Medical University
Hemodialysis Access Failure
Exploratory Research of PCSK9 Inhibitor on Patency of aAVF After PTA With PCB
Autologous arteriovenous fistula (AVF) is the preferred vascular pathway type for maintenance hemodialysis (MHD) patients. The K/DOQI guidelines suggest that the use of percutaneous transluminal angioplasty (PTA) as the primary…
- Trial name
- NCT06034691
- Testing
- pcsk9 inhibitor
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RenJi Hospital
Sepsis, Septic Shock
Treatment of Severe Infection With Antihyperlipidemia Drug
Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors increase LDL receptors by decreasing its degradation. In sepsis the pathogenic substances, endotoxin, lipoteichoic acid, phospholipomannan are the main cause of the…
- Trial name
- NCT03634293
- Testing
- Alirocumab Injectable Product, Saline Solution
- Where
- Israel
- Volunteers
- 712 people
- Sponsor
- Wolfson Medical Center
Hypercholesterolemia
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or…
- Trial name
- NCT06492291
- Testing
- Enlicitide Decanoate
- Where
- 222 sites in United States, Argentina and 26 more
- Volunteers
- 3,000 people
- Sponsor
- Merck Sharp & Dohme LLC
STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period
This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included <24h STEMI and…
- Trial name
- INCLINE-AMI (NCT07290699)
- Testing
- Recaticimab
- Volunteers
- 2,442 people
- Sponsor
- Second Affiliated Hospital of Nanchang University