Clinical trials: PCSK9 Inhibitor
Acute Myocardial Infarction (AMI)
Very Early PCSK9 Inhibition for Acute Myocardial Infarction
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease.
- Trial name
- NCT07208006
- Testing
- Standard Lipid-Lowering Therapy, Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)
- Where
- China
- Volunteers
- 1,518 people
- Sponsor
- Shanghai Zhongshan Hospital
Acute Ischemic Stroke
Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China.
- Trial name
- NCT06134635
- Testing
- Statins, Evolocumab
- Volunteers
- 80 people
- Sponsor
- Xuanwu Hospital, Beijing
Coronary Artery Disease
Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study
This pilot study aims to evaluate whether a single dose of PCSK9 inhibitor administered after percutaneous coronary intervention (PCI) can improve long-term cardiovascular outcomes in patients with high post-PCI lipid core…
- Trial name
- HANYANG-PICK (NCT07084259)
- Testing
- PCSK9 inhibitor, Standard Lipid-Lowering Therapy
- Volunteers
- 352 people
- Sponsor
- Hanyang University Seoul Hospital
Hypercholesterolemia, Dyslipidemias
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W [≤31 days]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic…
- Conditions
- Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
- Trial name
- NCT06568471
- Testing
- Lerodalcibep
- Where
- 18 sites in China
- Volunteers
- 210 people
- Sponsor
- Hasten Biopharmaceutical Co., Ltd.
Local Advanced Rectal Cancer, PD-1 Inhibitor
Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial
This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab…
- Conditions
- Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor, RCT
- Trial name
- NCT07686796
- Testing
- Short-course radiotherapy, CAPOX (oxaliplatin/capecitabine), Sintilimab
- Where
- China
- Volunteers
- 148 people
- Sponsor
- Guangdong Provincial People's Hospital
Atherosclerotic Cardiovascular Disease
Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardial Ischemia and Needing Coronarography
Proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibodies (anti-PCSK9) significantly reduce the serum LDL-C level, leading to a regression of the coronary epicardial plaque demonstrated by intracoronary…
- Trial name
- MICROPROTECT (NCT04338165)
- Testing
- Evolocumab 140 MG/ML [Repatha]
- Where
- France
- Volunteers
- 66 people
- Sponsor
- University Hospital, Grenoble
ASCVD, Atherosclerotic Cardiovascular Disease
Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer
This study is a prospective, randomized, open-label, and single center trial. To evaluate the effect of treatment with PCSK9 inhibitor on the risk for cardiovascular death, recurrent unstable angina, myocardial infarction…
- Conditions
- ASCVD, Atherosclerotic Cardiovascular Disease, Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor, Cancer
- Trial name
- NCT05976893
- Testing
- Evolocumab, Statin
- Volunteers
- 620 people
- Sponsor
- Xiang Xie
Biliary Tract Carcinoma
A Trial of Recaticimab and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable BTC
The study aims to evaluate the efficacy and safety of Recaticimab and Adebrelimab in Combination With chemotherapy in patients with metastatic biliary tract carcinoma (BTC).
- Trial name
- HP-BTC-002 (NCT07062328)
- Testing
- Recaticimab and Adebrelimab, GP chemotherapy
- Volunteers
- 39 people
- Sponsor
- Sun Yat-sen University
Atherosclerosis Cerebral, Carotid Plaque
RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque Remodeling
Carotid artery stenosis is a major cause of ischemic stroke. However, many strokes occur in patients with only mild-to-moderate stenosis.
- Conditions
- Atherosclerosis Cerebral, Carotid Plaque, Vulnerable Plaque, Carotid Stenosis
- Trial name
- RESCUE (NCT07819643)
- Testing
- Intervention 1, Intervention 3, Intervention 2
- Volunteers
- 120 people
- Sponsor
- Keqiang Zhao
Atherosclerosis, Cardiovascular Diseases
Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease
The INTENSITY-HIGH study aims to answer if there are any limits to LDL reduction in relation to benefiting vascular health, exploring the mechanisms by which secondary prevention in patients with established heart disease may…
- Trial name
- INTENSITY-HIGH (NCT03355027)
- Testing
- Alirocumab 150 MG/ML, Ezetimibe 10Mg Tablet, Atorvastatin 40Mg Tablet
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Carotid Stenosis
Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid Plaque
CAROTID-STABILISE is a phase III, multicentre, randomised, double-blind, placebo-controlled trial evaluating whether alirocumab 150 mg subcutaneously every 2 weeks, added to high-intensity statin therapy, produces greater…
- Trial name
- CAROTID-STABIL (NCT07586540)
- Testing
- Alirocumab, Atorvastatin
- Where
- 14 sites in Egypt, Jordan and 6 more
- Volunteers
- 280 people
- Sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies Organization
Acute Myocardial Infarction
Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction
This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web…
- Trial name
- NCT05292404
- Testing
- alirocumab, conventional treatment
- Where
- 5 sites in China
- Volunteers
- 160 people
- Sponsor
- Shanghai Tong Ren Hospital
Hypercholesterolemia, Chronic Kidney Disease Requiring Chronic Dialysis
Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients
Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol, reducing in turn the risk of cardiovascular events.
- Trial name
- NCT04397653
- Testing
- Evolocumab, Ezetimibe
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Policlinico Casilino ASL RMB
Aortic Valve Stenosis
PCSK9 Inhibitors in the Progression of Aortic Stenosis
Investigators plan evaluate whether PCSK9 inhibitors, a medication that can lower lipoprotein(a) and control dyslipidemia, can inhibit the progression of aortic stenosis, through a randomized controlled trial.
- Trial name
- NCT03051360
- Testing
- PCSK9 Inhibitor [EPC]
- Where
- South Korea
- Volunteers
- 140 people
- Sponsor
- Seoul National University Hospital
Hypercholesterolaemia
Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment…
- Trial name
- NCT05934292
- Testing
- Enlicitide Decanoate
- Where
- 5 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Intracranial Atherosclerosis, Intracranial Artery Stenosis
PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in…
- Conditions
- Intracranial Atherosclerosis, Intracranial Artery Stenosis, Atherosclerotic Plaque
- Trial name
- PISTIAS-2 (NCT06902740)
- Testing
- Recaticimab and Statin, Statin
- Where
- 19 sites in China
- Volunteers
- 300 people
- Sponsor
- Peking Union Medical College Hospital
Locally Advanced Rectal Cancer (LARC)
PCSK9 Inhibitor and PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy for pMMR/MSS Locally Advanced Rectal Cancer
This is a single-center, open-label, single-arm clinical study aimed at conducting a preliminary evaluation of the efficacy and safety of combining PCSK9 inhibitors and PD-1 inhibitors (dual inhibitors) with neoadjuvant…
- Trial name
- NCT06933251
- Testing
- Neoadjuvant Chemoradiotherapy Combined with PD-1 inhibitor Immunotherapy and PCSK9 Inhibitor Therapy
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Guangdong Provincial People's Hospital
Gastric Adenocarcinoma, Esophagogastric Juction Cancer
Tafolecimab Combined With Sintilimab and SOX in the Treatment of pMMR/MSS Gastric Cancer
Background: Gastric cancer remains a significant health burden globally, particularly in China, where the majority of patients present with advanced disease at diagnosis.
- Conditions
- Gastric Adenocarcinoma, Esophagogastric Juction Cancer, Proficient Mismatch Repair
- Trial name
- NCT07621562
- Testing
- Tafolecimab plus Sintilimab combined with SOX
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Hypercholesterolemia and Mixed Dyslipidemia
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable…
- Trial name
- NCT07278830
- Testing
- SAL003 140mg+Atorvastatin, SAL003 420mg+Atorvastatin
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Primary Hypercholesterolemia or Mixed Dyslipidemia
Efficacy and Safety of Inclisiran as Monotherapy in Chinese Adults With Low or Moderate ASCVD Risk and Elevated Low-density Lipoprotein Cholesterol.
The purpose of this study was to evaluate the efficacy and safety of inclisiran as a monotherapy in Chinese adults with low or moderate atherosclerotic cardiovascular disease (ASCVD) risk and elevated low-density lipoprotein…
- Trial name
- V-Mono China (NCT05888103)
- Testing
- Inclisiran
- Where
- 28 sites in China
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals