Clinical trials: High Cardiovascular Risk Patients
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
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
- Trial name
- NCT04195984
- Testing
- Mi-thos® valve and transapical delivery system
- Where
- 3 sites in China
- Volunteers
- 122 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
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
Atherosclerotic Cardiovascular Disease, Type 2 Diabetes
High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 Diabetes
To assess the efficacy and safety of moderate-intensity rosuvastatin/ezetimibe compared to high-intensity rosuvastatin in high atherosclerotic cardiovascular disease risk patients with type 2 diabetes
- Trial name
- NCT03403556
- Testing
- Rosuvamibe, Monorova
- Where
- 6 sites in South Korea
- Volunteers
- 140 people
- Sponsor
- Yuhan Corporation
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
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Lipoprotein Disorder
A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
The main purpose of this study is to evaluate the efficacy and safety of HRS-5632 in adult participants with elevated Lipoprotein(a) (Lp(a)) at high risk for cardiovascular events.
- Trial name
- NCT07185776
- Testing
- HRS-5632 Injection
- Where
- 2 sites in China
- Volunteers
- 203 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
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
Haematological Malignancy, Acute Myeloid Leukemia
Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies
A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.
- Conditions
- Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
- Trial name
- NCT04068597
- Testing
- CCS1477, Pomalidomide, Dexamethasone
- Where
- 39 sites in United States, France and 3 more
- Volunteers
- 250 people
- Sponsor
- CellCentric Ltd.
Hidradenitis Suppurativa
A Real-world Study of Patients With Hidradenitis Suppurativa and High Cardiovascular Risk or Established Coronary Plaque Treated With Secukinumab
The aim of this study is to assess the real-world effects of secukinumab in adult participants with moderate-to-severe Hidradenitis Suppurativa (HS), particularly focusing on its potential impact on coronary atherosclerotic…
- Trial name
- HOPE (NCT07454889)
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Cardiomyopathies, Cardiac Arrest
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal…
- Conditions
- Cardiomyopathies, Cardiac Arrest, Cardiac Arrhythmias, Sudden Cardiac Death
- Trial name
- WILLEM (NCT05890716)
- Testing
- AI-powered ECG analysis to detect cardiac arrhythmic episodes
- Where
- 13 sites in Netherlands, Spain
- Volunteers
- 5,342 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Plasma Cell Myeloma
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Primary Objectives: Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3 Part: To…
- Trial name
- NCT04270409
- Testing
- Isatuximab SAR650984, Lenalidomide, Dexamethasone
- Where
- 105 sites in United States, Australia and 22 more
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- Sanofi
Coronary Arteriosclerosis, Diabetes Mellitus, Type 2
Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol.
- Conditions
- Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Cerebrovascular Accident, Dyslipidemia
- Trial name
- ACTFAST 2 (NCT00442325)
- Testing
- Atorvastatin (Lipitor)
- Where
- 32 sites in Greece, Hungary and 6 more
- Volunteers
- 595 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.