Clinical trials: PCSK9 Inhibitor
Atherosclerotic Cardiovascular Disease
Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity
Clopidogrel is the most widely used P2Y12 receptor inhibitor and is the only agent of this class currently recommended in patients with stable coronary artery disease (CAD) undergoing PCI, and for the treatment of stroke or PAD.
- Trial name
- NCT03096288
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 259 people
- Sponsor
- University of Florida
Hypercholesterolemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment…
- Trial name
- NCT03510715
- Testing
- Alirocumab SAR236553 (REGN727), Atorvastatin, Simvastatin
- Where
- 10 sites in Brazil, Canada and 8 more
- Volunteers
- 18 people
- Sponsor
- Sanofi
Acute Coronary Syndrome
PCSK9 Inhibitor on ACS Patients With Multivessel Disease and Relatively Low LDL-C Level in Chinese Population
The study is an open-label, multicenter, and randomized study. The objective of this study is to demonstrate the effect of PCSK9 inhibitor on ACS patients with multivessel disease and relatively low LDL-C levels or LDL-C levels…
- Trial name
- NCT05043740
- Testing
- Repatha or Praluent
- Volunteers
- 1,360 people
- Sponsor
- Second Xiangya Hospital of Central South University
Symptomatic Intracranial Atherosclerotic Stenosis
PCSK9 Inhibitor for Intracranial Atherosclerotic Symptomatic Stenosis
An investigator-initiated, prospective, multicenter, randomized, double-blind, placebo-controlled trial comparing the 1-year incidence of stroke in patients with AIS or TIA within 7 days who are treated with either placebo or…
- Trial name
- PICASSO (NCT07119918)
- Testing
- Recaticimab
- Where
- China
- Volunteers
- 5,276 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Coronary Artery Disease
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's…
- Trial name
- V-PLAQUE (NCT05360446)
- Testing
- Inclisiran sodium 300 mg
- Where
- 89 sites in United States, Argentina and 16 more
- Volunteers
- 610 people
- Sponsor
- Novartis Pharmaceuticals
Intracranial Atherosclerosis, Acute Ischemic Stroke
Trial of PCSK9 Inhibition in Patients with Acute Stroke and Symptomatic Intracranial Atherosclerosis
This study will evaluate whether low-density lipoprotein (LDL-C) lowering with alirocumab results in greater change from baseline in intracranial atherosclerotic plaque at week 26 than control in adults with acute ischemic stroke…
- Conditions
- Intracranial Atherosclerosis, Acute Ischemic Stroke, ICAS - Intracranial Atherosclerosis
- Trial name
- TOPICAL-MRI (NCT05001984)
- Testing
- Alirocumab
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Chang Gung Memorial Hospital
Acute Coronary Syndromes
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors With Statin for ACS Patients
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD).
- Trial name
- NCT07736313
- Testing
- PCSK9 inhibitor plus rosuvastatin 20 mg tab, Rosuvastatin 20 Mg Oral Tablet
- Volunteers
- 120 people
- Sponsor
- Assiut University
Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
Cardiovascular diseases and cancers, the two leading causes of death in Canada, require cholesterol to sustain their progression.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreas Cancer, Metastatic Cancer
- Trial name
- NCT04862260
- Testing
- Cholesterol metabolism disruption
- Where
- 2 sites in Canada
- Volunteers
- 3 people
- Sponsor
- CHU de Quebec-Universite Laval
Heterozygous Familial Hypercholesterolemia (HeFH)
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol…
- Trial name
- NCT07058077
- Testing
- Enlicitide Decanoate
- Where
- 47 sites in United States, Australia and 17 more
- Volunteers
- 153 people
- Sponsor
- Merck Sharp & Dohme LLC
Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI
Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI
- Trial name
- C-STAR (NCT05661552)
- Testing
- Evolocumab 140 MG/ML, Rosuvastatin 5mg, Ezetimibe 10mg
- Where
- South Korea
- Volunteers
- 108 people
- Sponsor
- Yonsei University
Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer
Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients…
- Conditions
- Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer, Extensive-Stage Small-Cell Lung Cancer, Extensive Disease Small Cell Lung Cancer
- Trial name
- STAR-SCLC (NCT07061535)
- Testing
- Tafolecimab, Sintilimab (approved), Etoposide
- Where
- 5 sites in China
- Volunteers
- 40 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Acute Coronary Syndromes
Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)
The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of…
- Trial name
- ELITE-ACS (NCT06738758)
- Testing
- PCSK9 inhibitor, Statin+Ezetimibe/Hybutimibe compound, Statin
- Where
- China
- Volunteers
- 6,000 people
- Sponsor
- Yun Dai Chen
Hypercholesterolemia
A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health Subjects
JS002 is a recombinant humanized Anti- PCSK9 monoclonal antibody; This is a phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single…
- Trial name
- NCT04197817
- Testing
- JS002
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Acute Ischemic Stroke AIS, Intracranial Atherosclerosis ICAS
PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke
This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in…
- Conditions
- Acute Ischemic Stroke AIS, Intracranial Atherosclerosis ICAS, Atherosclerotic Plaque
- Trial name
- PISTIAS-3 (NCT07466251)
- Testing
- Recaticimab plus standard therapy
- Where
- 19 sites in China
- Volunteers
- 1,212 people
- Sponsor
- Peking Union Medical College Hospital
Heterozygous Familial Hypercholesterolemia
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with…
- Trial name
- LIBerate-FH (NCT04797104)
- Testing
- lerodalcibep
- Where
- 7 sites in United States, Israel and 3 more
- Volunteers
- 478 people
- Sponsor
- LIB Therapeutics LLC
Dyslipidemia, Cardiovascular Disease
Bococizumab HIV Evaluation (B-HIVE) Study
B-HIVE is a Phase 3, double blind, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of bococizumab 150 mg subcutaneously every 2 weeks to bococizumab placebo subcutaneously every 2…
- Trial name
- B-HIVE (NCT02524106)
- Testing
- Bococizumab
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of California, San Francisco
Homozygous Familial Hypercholesterolemia
A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH
AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double…
- Trial name
- NCT03933293
- Testing
- AK102, Statins, Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Akeso
STEMI
Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates…
- Trial name
- NCT06364124
- Testing
- evolocumab, standard post-treatment for STEMI
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Beijing Luhe Hospital