Clinical trials: High Cardiovascular Risk
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
Telmisartan Tab Hypertension
To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk
- Trial name
- NCT00890084
- Testing
- Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
- Volunteers
- 2,913 people
- Sponsor
- Boehringer Ingelheim
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Cardiovascular Disease
A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event
The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established…
- Trial name
- AZURE-Outcomes (NCT07000357)
- Testing
- AZD0780
- Where
- 1,452 sites in United States, Argentina and 34 more
- Volunteers
- 15,100 people
- Sponsor
- AstraZeneca
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-LDL (NCT01968967)
- Testing
- Bococizumab (PF-04950615; RN316)
- Where
- 249 sites in United States, Canada and 10 more
- Volunteers
- 2,139 people
- Sponsor
- Pfizer
Dyslipidemia
Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand
The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The required sample size is 1,260 patients from 50 hospitals across Thailand.
- Trial name
- NCT00684151
- Where
- 49 sites in Thailand
- Volunteers
- 1,240 people
- Sponsor
- AstraZeneca
Leukemia, Myelodysplastic Syndromes
Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT
This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease…
- Conditions
- Leukemia, Myelodysplastic Syndromes, Lymphomas, Multiple Myeloma
- Trial name
- NCT02786485
- Testing
- rivogenlecleucel, Rimiducid
- Sponsor
- Bellicum Pharmaceuticals
Hypercholesterolemia, Myocardial Infarction
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40…
- Trial name
- NCT00202878
- Testing
- ezetimibe/simvastatin, simvastatin
- Volunteers
- 18,144 people
- Sponsor
- Organon and Co
Stroke, PFO - Patent Foramen Ovale
The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
- Trial name
- PROOF (NCT04029233)
- Testing
- Occlutech PFO Occluder
- Where
- 17 sites in Canada, France and 2 more
- Volunteers
- 582 people
- Sponsor
- Occlutech International AB
Carotid Artery Stenosis
ViVEXX Carotid Revascularization Trial (VIVA)
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid…
- Trial name
- NCT00417963
- Testing
- Carotid Artery Stenting
- Volunteers
- 407 people
- Sponsor
- C. R. Bard
Lipid Metabolism Disorders
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This study is to demonstrate therapeutic comparability of Fluvastatin sodium Extended Release Tablets 80 mg QD and Fluvastatin sodium Immediate Release Capsules 40 mg BID in LDL-C lowering from baseline to week 12 (endpoint) in…
- Trial name
- NCT01551173
- Testing
- Fluvastatin sodium
- Where
- China
- Volunteers
- 436 people
- Sponsor
- Novartis Pharmaceuticals
Ischemic Stroke; Ischemic Attack, Transient
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE
The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
- Trial name
- LIBREXIA-STROK (NCT05702034)
- Testing
- Milvexian
- Where
- 880 sites in United States, Argentina and 45 more
- Volunteers
- 12,523 people
- Sponsor
- Janssen Research & Development, LLC
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
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
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.
Acute Leukemia, Multiple Myeloma
Study of 3D189 in Patients With Hematologic Malignancies
To assess the safety, immunogenicity and preliminary efficacy of 3D189 in patients with hematological malignancies.
- Conditions
- Acute Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma, Higher-risk Myelodysplastic Syndrome
- Trial name
- NCT05320809
- Testing
- 3D189
- Where
- 4 sites in China
- Volunteers
- 16 people
- Sponsor
- 3D Medicines
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.
Myocardial Infarction
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).
- Trial name
- NCT00414609
- Testing
- Aliskiren
- Where
- 23 sites in United States, Argentina and 21 more
- Volunteers
- 820 people
- Sponsor
- Novartis
Hypercholesterolemia
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
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 in comparison to ezetimibe 10 mg daily after 24…
- Trial name
- ODYSSEY EAST (NCT02715726)
- Testing
- Alirocumab, ezetimibe, atorvastatin
- Where
- 62 sites in China, India and 1 more
- Volunteers
- 615 people
- Sponsor
- Sanofi
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