Clinical trials: High Cardiovascular Risk
Cardiovascular Disease, High Cardiovascular Risk
A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with cardiovascular (CV) disease and/or multiple CV risk factors.
- Conditions
- Cardiovascular Disease, High Cardiovascular Risk, Obesity, Overweight
- Trial name
- CAMELLIA-TIMI (NCT02019264)
- Testing
- Lorcaserin hydrochloride
- Where
- 499 sites in United States, Australia and 6 more
- Volunteers
- 14,673 people
- Sponsor
- Eisai Inc.
Hypercholesterolemia
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40).
- Trial name
- NCT00782184
- Testing
- ezetimibe/simvastatin 10/40, atorvastatin 40 mg, atorvastatin 20 mg
- Volunteers
- 250 people
- Sponsor
- Organon and Co
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Cardiovascular Disease
The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and…
- Trial name
- SPIRE-1 (NCT01975376)
- Testing
- bococizumab (PF-04950615)
- Where
- 1,745 sites in United States, Argentina and 34 more
- Volunteers
- 16,784 people
- Sponsor
- Pfizer
Cardiovascular Disease
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and…
- Trial name
- SPIRE-2 (NCT01975389)
- Testing
- bococizumab (PF-04950615)
- Where
- 1,595 sites in United States, Argentina and 33 more
- Volunteers
- 10,564 people
- Sponsor
- Pfizer
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
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
- Trial name
- FLAME (NCT04795167)
- Where
- 11 sites in United States
- Volunteers
- 115 people
- Sponsor
- Inari Medical
Respiratory Syncytial Virus Infections
Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
The SYNAGIS Registry was carried out in order to gather comprehensive real-world data on the use of palivizumab in children at high risk for serious respiratory syncytial virus (RSV) disease.
- Trial name
- NCT01155193
- Volunteers
- 30,804 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
This phase II trial studies the effect of selinexor when combined with carfilzomib, daratumumab, and dexamethasone in treating patients with high-risk multiple myeloma that has come back (recurrent) or has not responded to…
- Trial name
- NCT04756401
- Testing
- Carfilzomib, Daratumumab, Dexamethasone
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Academic and Community Cancer Research United
Hyperlipidemia
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
- Trial name
- SPIRE-HR (NCT01968954)
- Testing
- Bococizumab (PF-04950615;RN316)
- Where
- 103 sites in United States, Australia and 7 more
- Volunteers
- 711 people
- Sponsor
- Pfizer
Dyslipidemia
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
- Trial name
- FOURIER OLE (NCT02867813)
- Testing
- Evolocumab
- Where
- 198 sites in United States, Czechia and 5 more
- Volunteers
- 5,035 people
- Sponsor
- Amgen
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Endocarditis
Early Surgery Versus Conventional Treatment in Infective Endocarditis
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines.
- Trial name
- EASE (NCT00750373)
- Testing
- Valve surgery with removal of vegetations
- Where
- 2 sites in South Korea
- Volunteers
- 76 people
- Sponsor
- Asan Medical Center
Preeclampsia, Obstetric Labor Complications
Pravastatin to Prevent Preeclampsia
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia…
- Conditions
- Preeclampsia, Obstetric Labor Complications, Hypertension in Pregnancy
- Trial name
- Pravastatin (NCT03944512)
- Testing
- Pravastatin
- Where
- 12 sites in United States
- Volunteers
- 102 people
- Sponsor
- The George Washington University Biostatistics Center
Traumatic Injury, Venous Thromboembolism
Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients
This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed on enoxaparin 30 mg twice daily for VTE…
- Trial name
- NCT02412982
- Testing
- Enoxaparin 40 mg q12h, Enoxaparin 30 mg q8h
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- University of Cincinnati
Hypercholesterolemia and High Risk for Cardiovascular Events
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when…
- Trial name
- AMG145 (NCT01652703)
- Testing
- Evolocumab
- Where
- 42 sites in Japan
- Volunteers
- 310 people
- Sponsor
- Amgen
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
Carotid Artery Stenosis
GORE Embolic Protection With Reverse Flow
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
- Trial name
- EMPiRE (NCT00594100)
- Testing
- GORE Flow Reversal System (GFRS)
- Where
- 2 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and 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 very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular
Heart Failure
The CASCADE HF Soft Launch and Calibration Phase I and II
Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring.
- Trial name
- NCT04738279
- Testing
- Non-Invasive Continuous Remote Patient Monitoring, Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Health