Clinical trials: ASCVD
Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents
Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support
The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol…
- Conditions
- Atherosclerotic Cardiovascular Disease, Atherosclerotic Cardiovascular Disease Risk Equivelents, Elevated Low Density Lipoprotein Cholesterol
- Trial name
- SPIRIT (NCT04807400)
- Testing
- Inclisiran, Behavioural Support, Background lipid lowering therapy
- Where
- 17 sites in United Kingdom
- Volunteers
- 892 people
- Sponsor
- Novartis Pharmaceuticals
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.
Cardiovascular Disease
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event
This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C.
- Trial name
- AZURE-LDL (NCT07000123)
- Testing
- AZD0780
- Where
- 404 sites in United States, Argentina and 20 more
- Volunteers
- 3,103 people
- Sponsor
- AstraZeneca
Atherosclerotic Cardiovascular Disease
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease.
- Trial name
- NCT07551492
- Testing
- HRS9531
- Where
- China
- Volunteers
- 9,262 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Primary Hypercholesterolemia, Mixed Dyslipidemia
A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed…
- Trial name
- NCT06386419
- Testing
- inclisiran
- Where
- 9 sites in India
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
Pelacarsen Roll-over Extension Program
This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).
- Trial name
- NCT06875973
- Testing
- Pelacarsen (TQJ230)
- Where
- 89 sites in United States, Puerto Rico
- Volunteers
- 599 people
- Sponsor
- Novartis Pharmaceuticals
ASCVD, Impaired Fasting Glucose
High-Dose Statin Combined With Telmisartan vs Amlodipine on Glucose Metabolism in ASCVD Patients With IFG and Hypertension
This study will evaluate the effect of high-dose rosuvastatin combined with telmisartan or amlodipine on glucose metabolism in ASCVD patients with impaired fasting glucose and hypertension.
- Conditions
- ASCVD, Impaired Fasting Glucose, Hypertension
- Trial name
- NCT03474562
- Testing
- Duowell®, Monorova® + Amlopin®
- Where
- 4 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Yuhan Corporation
Lipoprotein Disorder
A Study of DII235 in Adults With Elevated Lipoprotein(a)
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
- Trial name
- NCT07235046
- Testing
- DII235, Saline
- Where
- 63 sites in United States, China and 2 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
ASCVD
The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
cvMOBIUS is a North American registry of patients with ASCVD aimed at understanding patterns of care in ASCVD while evaluating the real world effectiveness of PCSK9 inhibitors.
- Trial name
- cvMOBIUS (NCT04197453)
- Where
- 164 sites in United States, Canada
- Volunteers
- 752 people
- Sponsor
- Amgen
ASCVD, Elevated Cholesterol
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
- Conditions
- ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia
- Trial name
- ORION-8 (NCT03814187)
- Testing
- Inclisiran Sodium
- Where
- 238 sites in United States, Canada and 11 more
- Volunteers
- 3,275 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia
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…
- Trial name
- STaRT (NCT06858332)
- Testing
- Atorvastatin, Simvastatin, Rozuvastatin
- Where
- 20 sites in Russia
- Volunteers
- 2,382 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease (ASCVD), Erectile Dysfunction
Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile Dysfunction
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
- Trial name
- NCT07311330
- Testing
- YN001 20mg Dose + 5% glucose injection, 5% glucose injection
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Beijing Inno Medicine Co., Ltd.
Medical Conditions to be Studied, Dyslipidemia
Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) a Registry of High Cardiovascular Risk Subjects in the United States
This is a multicenter observational cohort study with both retrospective and prospective data collection components in subjects with ASCVD.
- Conditions
- Medical Conditions to be Studied, Dyslipidemia, ASCVD Management
- Trial name
- NCT02993120
- Where
- 118 sites in United States
- Volunteers
- 5,006 people
- Sponsor
- Amgen
Acute Coronary Syndrome (ACS)
Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL
CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in…
- Trial name
- NCT07625306
- Testing
- Pelacarsen
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease
The Belgian REAL (BE.REAL) Registry
This is an observational non-interventional study. The visit schedule is according to the routine clinical practice. Only data corresponding to study variables within the specified study period will be collected.
- Trial name
- BE REAL (NCT05726838)
- Testing
- Inclisiran
- Volunteers
- 600 people
- Sponsor
- Novartis Pharmaceuticals
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
A Disease Area Study on the Awareness and Perceptions of Systemic Inflammation and hsCRP as a biomARKer in Patients With ASCVD and CKD in China Among Cardiologists and Nephrologists
This is a survey-based study with the objective to understand the awareness, perceptions and potential clinical management patterns among Chinese cardiologists and nephrologists towards the role of systemic inflammation in…
- Trial name
- SPARK-CVD (NCT06589791)
- Testing
- No treatment given
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Novo Nordisk A/S
ASCVD, Elevated Cholesterol
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability…
- Trial name
- ORION-10 (NCT03399370)
- Testing
- Inclisiran Sodium
- Where
- 145 sites in United States
- Volunteers
- 1,561 people
- Sponsor
- The Medicines Company
No Condition
CLAiR Pivotal Study
This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two…
- Trial name
- NCT06808334
- Testing
- CLAIR
- Where
- United States
- Volunteers
- 942 people, healthy volunteers welcome
- Sponsor
- Toku Eyes 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
Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease
Lp(a) Lowering Study of Pelacarsen (TQJ230) in US Black/African American and Hispanic Participants With Elevated Lp(a) and Established ASCVD
Study CTQJ230A12303 is a randomized, double-blind placebo-controlled, Phase IIIb study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) 80 mg s.c. QM compared with placebo s.c.
- Trial name
- NCT06267560
- Testing
- TQJ230
- Where
- 96 sites in United States, Puerto Rico
- Volunteers
- 422 people
- Sponsor
- Novartis Pharmaceuticals