Clinical trials: ASCVD
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
Coronary Artery Disease Progression
Intensive Lipid-lowering for Plaque and Major Adverse Cardiovascular Events in Low to Intermediate 10-year ASCVD Risk Population
Current guidelines recommend moderate-intensity lipid-lowering therapy (goal for LDL-C <2.6 mmol/L or 30%-50% reduction from baseline) for patients with intermediate 10-year ASCVD risk.
- Trial name
- ILLUMINATION (NCT05462262)
- Testing
- Intensive lipid-lowering control, Moderate-intensity lipid-lowering control
- Where
- China
- Volunteers
- 2,900 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
Heart Failure, ASCVD
Serial Biomarker Testing and Cardiovascular Risk Stratification (ACHILLES)
The goal of this observational study is to learn how blood levels of biomarkers, e.g. hsCRP and Lp(a) - two markers linked to heart disease risk - change over time in patients who have had these levels tested more than once.
- Conditions
- Heart Failure, ASCVD, CKD
- Trial name
- ACHILLES (NCT07817576)
- Where
- Germany
- Volunteers
- 110,000 people
- Sponsor
- University Hospital Freiburg
Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD)
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function.
- Trial name
- NCT06383390
- Testing
- Retatrutide
- Where
- 742 sites in United States, Argentina and 25 more
- Volunteers
- 10,000 people
- Sponsor
- Eli Lilly and Company
Cardiovascular Risk Factor, Cardiovascular Diseases
The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects.
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Adverse Effect
- Trial name
- DESIFOR (NCT03889314)
- Testing
- Rosuvastatin 20mg
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Minneapolis Heart Institute Foundation
ASCVD, LDL-C
Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?
The goal of this implementation trial is to learn if providing education to doctors and patients who have had a heart event works to prevent future heart problems. The main questions it aims to answer are: 1.
- Trial name
- T2T (NCT06471036)
- Testing
- Care Champion Intervention
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Duke University
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
VictORION-INCLUSION: Evaluating Inclisiran for Cholesterol Managment in Heart Disease
VictORION-INCLUSION (V-INCLUSION) seeks to evaluate the effectiveness of inclisiran as an innovative therapy with the potential to help bridge care gaps in historically understudied and undertreated populations by leveraging…
- Trial name
- V-INCLUSION (NCT06249165)
- Testing
- Inclisiran
- Where
- 23 sites in United States
- Volunteers
- 130 people
- Sponsor
- Duke University
Dyslipidemias, Atherosclerotic Cardiovascular Disease
Tracking of Lipid Lowering Therapy in Jordan
The present study aims to examine the clinical practice of modifying the dose of lipid-lowering therapy in patients with atherosclerotic cardiovascular disease (ASCVD), who have LDL-C > 70 mg/dl despite statin treatment.
- Trial name
- JoLLA (NCT05629767)
- Where
- 2 sites in Jordan
- Volunteers
- 1,000 people
- Sponsor
- Jordan Collaborating Cardiology Group
Dyslipidemia, Subclinical hypothyroïdism
Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)
In ASCVD patients complicated with subclinical hypothyroidism, the percentage of those who did not reach the target of lipid-lowering therapy (LDL-C>1.8mmol/L) is usually higher than that in population with normal thyroid…
- Conditions
- Dyslipidemia, Subclinical hypothyroïdism, Statin, ASCVD
- Trial name
- NCT03606824
- Testing
- Pitavastatin and levothyroxine
- Where
- China
- Volunteers
- 248 people
- Sponsor
- Shaochun.Li
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
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
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.
Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)
The objective of this study is to evaluate ischemic event rates among individuals with established atherosclerotic cardiovascular disease without prior acute ischemic events, comparing those treated with alirocumab versus those…
- Trial name
- OPTIMUS-IMPACT (NCT07615179)
- Testing
- Alirocumab, Comparator: No PCSK9i Therapy (either mAb or siRNA)
- Where
- United States
- Volunteers
- 4,545 people
- Sponsor
- Sanofi
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease (ASCVD)
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.
- Trial name
- PCSK9-DUO (NCT07581808)
- Testing
- Inclisiran, Alirocumab
- Where
- Slovenia
- Volunteers
- 60 people
- Sponsor
- University Medical Centre Ljubljana
Type 2 Diabetes Mellitus, Endothelial Dysfunction
Huangqi Gegen Decoction for Endothelial Function in Type 2 Diabetes at Very High ASCVD Risk
This clinical trial evaluates whether Huangqi Gegen Decoction can improve blood vessel function in adults with type 2 diabetes mellitus who are at very high risk of atherosclerotic cardiovascular disease and meet the traditional…
- Conditions
- Type 2 Diabetes Mellitus, Endothelial Dysfunction, Cardiovascular Risk
- Trial name
- NCT07775664
- Testing
- Huangqi Gegen Decoction Granules, Conventional Treatment
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Putuo Hospital, Shanghai University of Traditional Chinese Medicine
Type 2 Diabetes Mellitus, Arteriosclerotic Cardiovascular Disease
Observational Study of ASCVD Risks of Type 2 Diabetes in East China
The aim of this study is to screen patients with type 2 diabetes with high risk of cardiovascular disease, and intervene with or without Glucagon like peptide-1 receptor agonists.
- Conditions
- Type 2 Diabetes Mellitus, Arteriosclerotic Cardiovascular Disease, Liraglutide
- Trial name
- NCT04866667
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Zhejiang Provincial People's Hospital
Diabetes Mellitus, Type 2, Cardiovascular Diseases
Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes
This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended…
- Trial name
- NCT04862858
- Testing
- Educational Intervention
- Where
- United States
- Volunteers
- 4,197 people
- Sponsor
- Humana Inc.
ASCVD, Hyperlipidemia
Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors
This project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol.
- Conditions
- ASCVD, Hyperlipidemia, Hypertension
- Trial name
- DUKE PREVENT (NCT07117695)
- Testing
- Referral to the Duke Cardiometabolic Prevention Clinic
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Duke University
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