Clinical trials: High Cardiovascular Risk Patients
- Condition High Cardiovascular Risk Patients
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Hypercholesterolemia
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
- Trial name
- NCT01644188
- Testing
- Alirocumab, Ezetimibe, Lipid Modifying Therapy (LMT)
- Where
- 126 sites in United States, Canada and 8 more
- Volunteers
- 720 people
- Sponsor
- Sanofi
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Dyslipidemia, Cardiovascular Diseases
Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events
High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete.
- Conditions
- Dyslipidemia, Cardiovascular Diseases, Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Trial name
- SANTORINI (NCT04271280)
- Testing
- Non-interventional
- Where
- 540 sites in Austria, Belgium and 12 more
- Volunteers
- 9,559 people
- Sponsor
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Hypercholesterolaemia
Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Primary Objective: To collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as SYDNEY), in unsupervised settings.
- Trial name
- NCT03415178
- Testing
- Alirocumab SAR236553, Current auto-injector device (AI), New auto-injector device (SYDNEY)
- Where
- 13 sites in United States
- Volunteers
- 69 people
- Sponsor
- Sanofi
Cardiovascular Diseases, Coronary Artery Disease
Study On Liprimar (Atorvastatin) In Patients With Coronary Heart Disease (CHD) And High Risk Of Cardiovascular Complications
In which CHD patients with high risk of CV complications are different doses of LIPRIMAR used? For this purpose, data on hyperlipidemia will be elicited over and above the basic nosographic and demographic data, concomitant…
- Trial name
- LIGHT (NCT00993915)
- Testing
- Atorvastatin
- Volunteers
- 687 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Atherosclerotic Cardiovascular Disease
Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients.
- Trial name
- BETTER (NCT05761444)
- Testing
- Atozet 10/40 mg or 10/80 mg, Lipitor 40 mg or 80 mg
- Where
- 7 sites in South Korea
- Volunteers
- 137 people
- Sponsor
- Organon and Co
Diabetes
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
The study aims to investigate the clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease (CVD), chronic kidney disease (CKD)…
- Trial name
- NCT04903496
- Where
- China
- Volunteers
- 1,233,162 people
- Sponsor
- Boehringer Ingelheim
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to…
- Trial name
- STRENGTH (NCT02104817)
- Testing
- Epanova® (omega-3 carboxylic acids), corn oil control
- Where
- 684 sites in United States, Australia and 20 more
- Volunteers
- 13,078 people
- Sponsor
- AstraZeneca
Hypercholesterolemia
Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with…
- Trial name
- NCT02107898
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT)
- Where
- 32 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Sanofi
Coronary Artery Disease
SHIELD II Clinical Investigation
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with…
- Trial name
- SHIELD II (NCT02468778)
- Testing
- HeartMate PHP, Any Abiomed Impella® device approved for use in high-risk PCI
- Where
- 58 sites in United States
- Volunteers
- 54 people
- Sponsor
- Abbott Medical Devices
High-risk Smoldering Multiple Myeloma
A Study of Siltuximab (Anti- IL 6 Monoclonal Antibody) in Patients With High-risk Smoldering Multiple Myeloma
The purpose of this study is to evaluate the safety and efficacy of siltuximab compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) in patients…
- Trial name
- NCT01484275
- Testing
- Siltuximab
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 85 people
- Sponsor
- Janssen Research & Development, LLC
Dyslipidemia
Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.
- Trial name
- EBBINGHAUS (NCT02207634)
- Testing
- Evolocumab, Background Statin Therapy
- Where
- 416 sites in United States, Australia and 28 more
- Volunteers
- 1,974 people
- Sponsor
- Amgen
Coronary Artery Disease
A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
The purpose of this trial is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving…
- Trial name
- Onyx ONE Clear (NCT03647475)
- Testing
- Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
- Where
- 4 sites in United States
- Volunteers
- 752 people
- Sponsor
- Medtronic Vascular
Hypercholesterolemia
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia…
- Trial name
- NCT01709513
- Testing
- Atorvastatin, Ezetimibe, Alirocumab
- Where
- 70 sites in United States, Austria and 6 more
- Volunteers
- 314 people
- Sponsor
- Regeneron Pharmaceuticals
Hypertension
Effectiveness and Tolerability of Tarka® in the Treatment of Hypertensive Patients With High Risk of Developing Diabetes Mellitus
The aim of this post-marketing observational study (PMOS) is to provide data on the effectiveness and tolerability of Tarka in patients with a high risk of developing diabetes mellitus, as prescribed by the physicians in a…
- Trial name
- TARDIA (NCT01079195)
- Where
- 898 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 15,436 people
- Sponsor
- Abbott
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII S3HR/NR7 (NCT03222141)
- Testing
- TAVR Implantation of the THV Prosthesis
- Where
- 40 sites in United States, Canada
- Volunteers
- 583 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
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
Hypertension, Cardiovascular Diseases
Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients
The study is designed to evaluate the effect of treatment with Micardis/MicardisPlus on blood pressure and its ability to reduce different indicated cardiovascular risks.
- Trial name
- NCT00904371
- Where
- 36 sites in Slovenia
- Volunteers
- 211 people
- Sponsor
- Boehringer Ingelheim