Clinical trials: High Cardiovascular Risk Patients
Mitral Regurgitation
Valveclip® Transcatheter Mitral Valve Repair Study
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
- Trial name
- NCT05021614
- Testing
- Valveclip® Transcatheter mitral valve repair
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Venous Thromboembolism, Cancer
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and…
- Trial name
- SAVE-ONCO (NCT00694382)
- Testing
- Semuloparin sodium
- Where
- 411 sites in United States, Argentina and 47 more
- Volunteers
- 3,212 people
- Sponsor
- Sanofi
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
Carotid Artery Disease, Carotid Stenosis
Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study
The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that…
- Conditions
- Carotid Artery Disease, Carotid Stenosis, Stroke
- Trial name
- ASTI (NCT01133327)
- Testing
- Carotid Artery Stenting
- Where
- 11 sites in Belgium, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Pulmonary Embolism
Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary…
- Trial name
- NCT06362746
- Testing
- Non-immunogenic recombinant staphylokinase
- Where
- 24 sites in Russia
- Volunteers
- 486 people
- Sponsor
- Supergene, LLC
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Acute Renal Failure, Acute Kidney Injury
A Dose Escalation and Safety Study of I5NP to Prevent Acute Kidney Injury (AKI) in Patients at High Risk of AKI Undergoing Major Cardiovascular Surgery (QRK.004)
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 10 sites in the United States.
- Trial name
- NCT00683553
- Testing
- I5NP
- Where
- 10 sites in United States
- Volunteers
- 3 people
- Sponsor
- Quark Pharmaceuticals
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
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
Blood Loss, Surgical, Coagulation Disorder
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that…
- Trial name
- EQUILIBRIX-S (NCT07288489)
- Testing
- Reltodecacog alfa, Usual Pharmacological Care
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 800 people
- Sponsor
- VarmX B.V.
Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC)
Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications
This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1…
- Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM), Metastatic Colorectal Cancer (mCRC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Higher-Risk Myelodysplastic Syndrome (HR-MDS)
- Trial name
- NCT02649790
- Testing
- KPT-8602, ASTX727, Dexamethasone
- Where
- 46 sites in United States, Canada and 3 more
- Volunteers
- 277 people
- Sponsor
- Karyopharm Therapeutics Inc
Hypercholesterolemia, Cardiovascular Diseases
Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients
Comparison of LDL-C reductions at Week 12 of monthly (Q4W[≤ 31 days]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or…
- Trial name
- LIBerate-H2H (NCT04790513)
- Testing
- lerodalcibep, evolocumab, alirocumab
- Where
- 3 sites in United States
- Volunteers
- 204 people
- Sponsor
- LIB Therapeutics LLC
Aortic Valve Stenosis
PrizValve® Transcatheter Aortic Valve Replacement Study
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not…
- Trial name
- NCT04836897
- Testing
- PrizValve® valve and transapical delivery system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Fabry Disease
Study Based on Electronic Health RecOrds to Identify Patients at High-risk of Fabry DiseasE (HOPE Fabry)
Primary objective: To estimate the prevalence of patients who are at high-risk for Fabry Disease (FD) in the Cleveland Clinic, Abu Dhabi (CCAD) United Arab Emirates (EMR) database from May 2016 to May 2022, according to the…
- Trial name
- NCT05671770
- Where
- United Arab Emirates
- Volunteers
- 15 people
- Sponsor
- Sanofi
High Risk Cardiovascular Disease, Hypertension
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events.
- Conditions
- High Risk Cardiovascular Disease, Hypertension, High Cardiovascular Risk
- Trial name
- ZENITH (NCT07181109)
- Testing
- Zilebesiran
- Where
- 1,190 sites in United States, Argentina and 33 more
- Volunteers
- 11,000 people
- Sponsor
- Alnylam Pharmaceuticals
Multiple Myeloma
A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)
This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma…
- Trial name
- NCT05181501
- Testing
- Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)
- Where
- 4 sites in China
- Volunteers
- 20 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.
Aortic Regurgitation, Aortic Disease
Prospective Multicenter Study Evaluating Myval TAVR Safety and Effectiveness in High-risk Severe AR
Prospective study is designed to evaluate the safety and efficacy of Myval THV series in patients with severe symptomatic non- or mild-calcified aortic regurgitation.
- Conditions
- Aortic Regurgitation, Aortic Disease, Calcified Aortic Valve
- Trial name
- MARVELTAVI (NCT07751965)
- Testing
- Myval THV series
- Volunteers
- 164 people
- Sponsor
- Ceric Sàrl
Coronary Artery Disease, Coronary Syndrome
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With (N)STEMI or Unstable Angina
The POLARSTAR study is an early safety and feasibility study to evaluate the performance and safety of the CryoTherapy System (CTS) for the treatment of coronary plaque lesions that are not obstructing blood flow but are at…
- Conditions
- Coronary Artery Disease, Coronary Syndrome, Cryotherapy Effect, Myocardial Infarction
- Trial name
- POLARSTAR (NCT05600088)
- Testing
- CryoTherapy System (CTS)
- Where
- 5 sites in Georgia, Lithuania
- Volunteers
- 24 people
- Sponsor
- Cryotherapeutics SA
Respiratory Syncytial Virus Infections
A Study of Ziresovir (AK0529) in High-risk Adult With Respiratory Syncytial Virus (RSV) Infection.
Respiratory syncytial virus (RSV) is recognized worldwide as a significant pathogen causing lower respiratory tract infection in infants, the elderly, and immunocompromised patients, which may cause bronchiolitis or pneumonia…
- Trial name
- NCT07658534
- Testing
- Ziresovir (AK0529)
- Where
- 9 sites in China
- Volunteers
- 290 people
- Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.