Clinical trials: High Cardiovascular Risk Patients
Stable Angina, Ischemic Heart Disease Silent
A Randomized Clinical Evaluation of the BioFreedom™ Stent
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and…
- Conditions
- Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction, In-stent Coronary Artery Restenosis
- Trial name
- Leaders Free (NCT01623180)
- Testing
- Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
- Where
- Switzerland
- Volunteers
- 2,456 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease
Protect II, A Prospective, Multicenter Randomized Controlled Trial
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
- Trial name
- PROTECT II (NCT00562016)
- Testing
- IMPLELLA LP 2.5, IABP Intra-aortic balloon pump
- Where
- 50 sites in United States, Canada and 1 more
- Volunteers
- 452 people
- Sponsor
- Abiomed Inc.
Hypertriglyceridemia, Cardiovascular Diseases
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
This was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS…
- Trial name
- NCT03385239
- Testing
- ISIS 678354
- Where
- 31 sites in United States, Canada
- Volunteers
- 114 people
- Sponsor
- Akcea Therapeutics
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
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.
- Trial name
- CLEAR Wisdom (NCT02991118)
- Testing
- bempedoic acid
- Where
- 2 sites in United States
- Volunteers
- 779 people
- Sponsor
- Esperion Therapeutics, Inc.
Mitral Valve Regurgitation, Mitral Valve Insufficiency
HighLife™ Transcatheter Mitral Valve Replacement System Study
Multicenter feasibility study of the HighLife™ TMVR system.
- Trial name
- NCT02974881
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 10 sites in France, Germany
- Volunteers
- 5 people
- Sponsor
- HighLife SAS
Tricuspid Regurgitation
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients…
- Trial name
- SPACER (NCT07172477)
- Testing
- Pivot Extend
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Tau Medical Australia Pty Ltd
Coronary Artery Disease
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
The purpose of this study 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 (NCT03344653)
- Testing
- Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Biosensors BioFreedom BA9 Drug Coated Coronary Stent
- Where
- 89 sites in Australia, Austria and 21 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic Vascular
Neoplasms
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein…
- Trial name
- NCT02555878
- Testing
- Rivaroxaban
- Where
- 151 sites in United States, Belgium and 8 more
- Volunteers
- 841 people
- Sponsor
- Janssen Research & Development, LLC
Hypercholesterolaemia
Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin)
Primary Objectives: To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in participants with diabetes treated with insulin and with…
- Trial name
- NCT02585778
- Testing
- Alirocumab, Lipid-Modifying Therapy (LMT), Antihyperglycemic Drug
- Where
- 110 sites in United States, Austria and 8 more
- Volunteers
- 517 people
- Sponsor
- Sanofi
Stable Angina (SA), NSTE-ACS (NSTEMI and UA)
Utilisation of Angiox® in European Practice
The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres.
- Conditions
- Stable Angina (SA), NSTE-ACS (NSTEMI and UA), STEMI (STE-ACS)
- Trial name
- EURO-vision (NCT01011504)
- Where
- 2 sites in France, Germany
- Volunteers
- 2,019 people
- Sponsor
- The Medicines Company
Vascular Diseases
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque
- Trial name
- NCT00570752
- Testing
- BMS-582949, Atorvastatin, Statin
- Where
- 17 sites in United States
- Volunteers
- 72 people
- Sponsor
- Bristol-Myers Squibb
Hypercholesterolemia
MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with…
- Trial name
- NCT01154036
- Testing
- ezetimibe 10 mg, atorvastatin, Comparator: rosuvastatin
- Volunteers
- 1,547 people
- Sponsor
- Organon and Co
Cardiovascular Risk
C2 -CORVUS Cholesterol-Control (C2) Controlled Targets for High Vascular Risk Patients Using Effective Statins (CORVUS)
To demonstrate a higher percent rate of achieved target lipid goals among patients at high cardiovascular risk using more potent lipid-lowering treatment options including high-potency statins and combination therapies.
- Trial name
- C2 -CORVUS (NCT00921752)
- Where
- 26 sites in Hungary
- Volunteers
- 1,500 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
The aim of the study is to investigate the longterm impact on cardiovascular morbidity, mortality and renal function of treatment with linagliptin in a selected population of patients with Type 2 diabetes mellitus (T2DM) and to…
- Trial name
- NCT01897532
- Testing
- Linagliptin
- Where
- 649 sites in United States, Argentina and 25 more
- Volunteers
- 6,991 people
- Sponsor
- Boehringer Ingelheim
Coronary Artery Disease, Stable Angina Pectoris
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients…
- Conditions
- Coronary Artery Disease, Stable Angina Pectoris, Unstable Angina Pectoris
- Trial name
- NCT02747329
- Testing
- BuMA Supreme™ stent, Xience V/Prime stent
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Sino Medical Sciences Technology Inc.
Hypertension
Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk 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 risk scores.
- Trial name
- NCT01108809
- Testing
- Telmisartan or Telmisartan and Hydrochlorthiazide
- Where
- 49 sites in Romania
- Volunteers
- 295 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin
In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs)…
- Trial name
- NCT05819125
- Where
- United States
- Volunteers
- 21,000 people
- Sponsor
- Sanofi
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Acute Myocardial Infarction
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III).
- Trial name
- NCT00157768
- Testing
- Implantable cardioverter defibrillator
- Where
- Netherlands
- Volunteers
- 900 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure