Clinical trials: High Cardiovascular Risk Patients
Diabetes Mellitus, Non-Insulin-Dependent, High Risk for Cardiovascular Event
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or…
- Trial name
- DECLARE-TIMI58 (NCT01730534)
- Testing
- Dapagliflozin 10 mg
- Where
- 805 sites in United States, Argentina and 32 more
- Volunteers
- 17,190 people
- Sponsor
- AstraZeneca
Elevated Lipoprotein(a)
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral SAL0137 in Adults With Elevated Lp(a) and Increased Risk of Cardiovascular Events
This is a randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy and safety of oral SAL0137 in adults with elevated Lp(a) and high cardiovascular risk.
- Trial name
- NCT07729475
- Testing
- SAL0137 Dose 1, SAL0137 Dose 2, SAL0137 Dose 3
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Carotid Artery Disease
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of…
- Trial name
- NCT00231270
- Testing
- Cordis Nitinol Stent, PRECISE tapered stent, ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
- Volunteers
- 1,300 people
- Sponsor
- Cordis US Corp.
Acute Myocardial Infarction
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.
- Trial name
- PARADISE-MI (NCT02924727)
- Testing
- LCZ696 (sacubitril/valsartan), Ramipril, Valsartan
- Where
- 486 sites in United States, Argentina and 39 more
- Volunteers
- 5,669 people
- Sponsor
- Novartis Pharmaceuticals
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
Smoldering Multiple Myeloma (SMM)
A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Adult Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
This study is researching an investigational drug called linvoseltamab ("study drug") in participants at high risk of developing Multiple Myeloma (MM), a group commonly labeled as High-Risk Smoldering Multiple Myeloma (HR-SMM).
- Trial name
- NCT05955508
- Testing
- Linvoseltamab
- Where
- 17 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
- Trial name
- NCT00479713
- Testing
- ezetimibe (+) simvastatin, Comparator : rosuvastatin calcium
- Volunteers
- 618 people
- Sponsor
- Organon and Co
Dyslipidemia
Dyslipidemia in Cardiovascular Disease
A multi-center, randomized, double-blinded equivalence clinical trial to evaluate efficacy and safety of LipiLou 20 mg versus Lipitor 20 mg in hypercholesterolemic patients with higher risk cardiovascular disease in Korea.
- Trial name
- KoLipilou (NCT01029522)
- Testing
- Atorvastatin (Lipilou), Atorvastatin (Lipitor)
- Volunteers
- 244 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Atrial Fibrillation
Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation
Atrial fibrillation is associated with increased risk of stroke mostly because of clot formation in the left atrial appendage, a small alcove in the left atrium heart chamber.
- Trial name
- NCT03526471
- Testing
- Omega™ Left Atrial Appendage (LAA) Occluder
- Where
- 2 sites in Denmark, Thailand
- Volunteers
- 20 people
- Sponsor
- Vascular Innovations Co. Ltd.
Cardiovascular Diseases, Statin Adverse Reaction
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo
The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are…
- Trial name
- CLEAR Outcomes (NCT02993406)
- Testing
- Bempedoic acid 180 mg tablet
- Where
- 1,319 sites in United States, Argentina and 30 more
- Volunteers
- 13,970 people
- Sponsor
- Esperion Therapeutics, Inc.
Heart Disease, Coronary Arterial Disease (CAD)
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular…
- Conditions
- Heart Disease, Coronary Arterial Disease (CAD), Heart Failure
- Trial name
- NCT07407816
- Testing
- Supira System
- Where
- 2 sites in Georgia
- Volunteers
- 45 people
- Sponsor
- Supira Medical
Non ST Segment Elevation Myocardial Infarction, Unstable Angina
Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation
This non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®, Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI.
- Trial name
- VECOR (NCT01356992)
- Testing
- Enoxaparin
- Where
- 5 sites in Brazil
- Volunteers
- 62 people
- Sponsor
- Eurofarma Laboratorios S.A.
Cardiovascular Disease
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With Clinical ASCVD or at Risk for a First ASCVD Event
This is a study to evaluate the efficacy and safety of AZD0780 in adults with clinical ASCVD or who are at risk for a first ASCVD event and who have elevated LDL-C.
- Trial name
- AZURE-LDL (NCT07000123)
- Testing
- AZD0780
- Where
- 404 sites in United States, Argentina and 20 more
- Volunteers
- 3,103 people
- Sponsor
- AstraZeneca
Dyslipidemia
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at…
- Trial name
- NCT02642159
- Testing
- Alirocumab, Statins, Ezetimibe
- Where
- 119 sites in United States, Australia and 13 more
- Volunteers
- 413 people
- Sponsor
- Sanofi
Venous Thromboembolism
Prophylactic Use of Sodium Enoxaparin for Venous Thromboembolism in High-Risk Abdominal Surgery
The purpose of this study is to compare the safety and security and efficacy of sodium enoxaparin Cristália Produtos Químicos Farmaceuticos Ltda - Endocris with Clexane (Sanofi-Aventis) to prevent Venous Thromboembolism in…
- Trial name
- NCT01308528
- Testing
- Sodium enoxaparin, Sodium Enoxaparin clexane
- Where
- 9 sites in Brazil
- Volunteers
- 243 people
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Acute Coronary Syndrome
Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)
The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST…
- Trial name
- FUTURA/OASIS 8 (NCT00790907)
- Testing
- fondaparinux background and standard dose UFH, Fondaparinux background and low dose heparin, Open label fondaparinux
- Where
- 203 sites in United States, Argentina and 16 more
- Volunteers
- 3,235 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
Effect of Efpeglenatide on Cardiovascular Outcomes
Primary Objective: To demonstrate that efpeglenatide 4 and 6 mg was noninferior to placebo on 3-point major adverse cardiac events (MACE) in Type 2 diabetes mellitus (T2DM) participants at high cardiovascular (CV) risk.
- Trial name
- AMPLITUDE-O (NCT03496298)
- Testing
- Efpeglenatide (SAR439977)
- Where
- 353 sites in United States, Argentina and 26 more
- Volunteers
- 4,076 people
- Sponsor
- Sanofi
Atrial Fibrillation (AF)
Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in…
- Trial name
- LILAC-TIMI 76 (NCT07739888)
- Testing
- Abelacimab
- Volunteers
- 2,500 people
- Sponsor
- Novartis Pharmaceuticals
Anemia, Diabetes, Kidney Disease, Chronic, Hypertension
Study of Anemia in Chronic Kidney Disease (CKD) Among High-Risk Hypertensive and Diabetic Patients in Pakistan
The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists.
- Trial name
- NCT02444845
- Where
- 3 sites in Pakistan
- Volunteers
- 246 people
- Sponsor
- Hoffmann-La Roche
Venous Thromboembolism (VTE), Cancer
Vortosiran for VTE Prevention
Blood clots remain a serious cause of illness and death. Long-term treatment and prevention of these clots with blood thinners is often limited by bleeding risk, drug interactions, and daily dosing, leading many patients to stop…
- Conditions
- Venous Thromboembolism (VTE), Cancer, Pulmonary Embolism (Diagnosis)
- Trial name
- NCT07850453
- Testing
- Vortosiran
- Where
- 30 sites in Bulgaria, France and 2 more
- Volunteers
- 150 people
- Sponsor
- Ribocure Pharmaceuticals AB