Clinical trials: High Risk Cardiovascular Disease
Hypercholesterolemia
A Study of PCSK9 Inhibitor AK102 in Patients With Hypercholesterolemia
This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the safety and efficacy of AK102 in patients with Hypercholesterolemia Patients at Very High or High Risk of Cardiovascular Disease .
- Trial name
- NCT04358432
- Testing
- AK102, Statins and/or Ezetimibe
- Where
- 2 sites in China
- Volunteers
- 262 people
- Sponsor
- Akeso
Hyperlipidemia
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.
- Trial name
- SPIRE-LL (NCT02100514)
- Testing
- Bococizumab (PF-04950615; RN316)
- Where
- 223 sites in United States, Canada and 10 more
- Volunteers
- 746 people
- Sponsor
- Pfizer
Angina, Unstable, Angioplasty, Transluminal, Percutaneous Coronary
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.
- Trial name
- NCT00269893
- Testing
- Abciximab
- Volunteers
- 2,038 people
- Sponsor
- Centocor, Inc.
Chronic Kidney Disease, Diabetic Kidney Disease
A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.
In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys.
- Trial name
- ASSESS-CKD (NCT04661917)
- Testing
- BAY2327949
- Where
- 36 sites in Austria, Denmark and 5 more
- Sponsor
- Bayer
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Mitral Regurgitation
Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery.
- Trial name
- NCT03714412
- Testing
- Implantation
- Where
- 2 sites in Greece, Poland
- Sponsor
- Cardiovalve Ltd.
Cardiovascular Diseases
Evaluating the Effectiveness of a Computerized Medication Adherence System at Reducing Cardiovascular Disease Risk Factors
High blood pressure and high cholesterol are both causes of cardiovascular disease (CVD), and it is important for people with these conditions to adhere to their medication regimens.
- Trial name
- NCT00796172
- Testing
- Medication Adherence System (MAS), Usual Care
- Where
- United States
- Volunteers
- 308 people
- Sponsor
- PHCC LP
Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lp(a)
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
- Trial name
- NCT06292013
- Testing
- Lepodisiran Sodium
- Where
- 928 sites in United States, Argentina and 26 more
- Volunteers
- 17,300 people
- Sponsor
- Eli Lilly and Company
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
Hypercholesterolemia
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT)…
- Trial name
- NCT02289963
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 27 sites in South Korea, Taiwan
- Volunteers
- 199 people
- Sponsor
- Sanofi
Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current…
- Trial name
- NCT02666664
- Testing
- ETC-1002
- Where
- 104 sites in United States, Canada and 4 more
- Volunteers
- 2,230 people
- Sponsor
- Esperion Therapeutics, Inc.
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
Tachycardia, Ventricular
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory…
- Trial name
- RADIATE-VT (NCT05765175)
- Testing
- Varian Cardiac Radioablation (CRA), Catheter Ablation (CA)
- Where
- 11 sites in United States
- Volunteers
- 380 people
- Sponsor
- Varian, a Siemens Healthineers Company
Coronary Heart Disease (CHD)
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a…
- Trial name
- VESALIUS-CV (NCT03872401)
- Testing
- Evolocumab
- Where
- 852 sites in United States, Argentina and 31 more
- Volunteers
- 12,301 people
- Sponsor
- Amgen
Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated…
- Conditions
- Atherosclerotic Cardiovascular Disease, Symptomatic Atherosclerosis, Type2 Diabetes, Familial Hypercholesterolemia
- Trial name
- ORION-3 (NCT03060577)
- Testing
- Inclisiran, Evolocumab
- Where
- 52 sites in United States, Canada and 3 more
- Volunteers
- 382 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Stenosis
Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study
The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are…
- Trial name
- NCT05864456
- Testing
- Prizvalve Pro™ transcatheter aortic valve system
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Heart Failure, Hyperkalemia
Cardiovascular and Renal Treatment in Heart Failure Patients With Hyperkalaemia or at High Risk of Hyperkalaemia
The CARE-HK in HF is a registry study based on the hypothesis that adherence to guidelines is associated with improved real-world outcomes for heart failure (HF) patients.
- Trial name
- CARE-HK (NCT04864795)
- Where
- 116 sites in United States, Austria and 5 more
- Volunteers
- 2,636 people
- Sponsor
- Vifor (International) Inc.
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices