Clinical trials: Coronary Artery Disease Risk High
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.
Coronary Artery Disease
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
- Trial name
- NCT06445608
- Testing
- Percutaneous Mechanical Circulatory Support
- Where
- 18 sites in United States
- Volunteers
- 310 people
- Sponsor
- Kardion Inc
High Risk PCI, Coronary Arterial Disease (CAD)
Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial
This study is conducted to compare the effectiveness of a new percutaneous mechanical circulatory support device called SynFlow 3.0 with VA-ECMO in high-risk percutaneous coronary intervetnion(PCI) patients.
- Trial name
- PERSIST Ⅲ (NCT06853470)
- Testing
- VA-ECMO circulatory support, SynFlow 3.0 circulatory support, percutaneous coronary intervention
- Where
- China
- Volunteers
- 222 people
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd
High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
- Trial name
- VITALYST EFS (NCT06132568)
- Testing
- VITALYST System
- Where
- 5 sites in United States, Sweden
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG)…
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury
- Trial name
- NCT00402506
- Testing
- (MC-1) Pyridoxal 5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 3,000 people
- Sponsor
- Medicure
Acute Coronary Syndrome, Type 2 Diabetes
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to "open" coronary…
- Trial name
- NCT00320502
- Testing
- BXT-51072
- Where
- 4 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Synvista Therapeutics, Inc
Coronary Heart Disease
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
The purpose of this study is to evaluate the safety and cholesterol lowering effects of MPSK3169A when given as subcutaneous (SC) injections over a 24-week period to patients with a high risk of cardiovascular events and LDL-c…
- Trial name
- NCT01609140
- Testing
- MPSK3169A
- Where
- 73 sites in United States, Canada and 7 more
- Volunteers
- 248 people
- Sponsor
- Genentech, Inc.
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 Stenosis
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding.
- Trial name
- NCT03877848
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- Israel
- Volunteers
- 319 people
- Sponsor
- Medinol Ltd.
Cardiovascular Risk Factor, Cardiovascular Diseases
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a…
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Cardiovascular Stroke, Hypercholesterolemia
- Trial name
- LIBerate-HR (NCT04806893)
- Testing
- lerodalcibep
- Where
- 6 sites in United States, India and 1 more
- Volunteers
- 900 people
- Sponsor
- LIB Therapeutics LLC
Dyslipidemias
A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
- Trial name
- NCT00644709
- Testing
- Atorvastatin
- Where
- 15 sites in Belgium
- Volunteers
- 196 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Atherosclerosis, Cardiovascular Diseases
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Lipoprotein(a)
- Trial name
- ACCLAIM-CTA (NCT07613294)
- Testing
- Lepodisiran
- Where
- 57 sites in United States, Australia and 5 more
- Volunteers
- 252 people
- Sponsor
- Eli Lilly and Company
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
Coronary Artery Disease
On Versus Off Pump Myocardial Revascularization Study
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery.
- Trial name
- On-Off (NCT01290952)
- Testing
- Off-pump bypass surgery, On-pump bypass surgery
- Where
- 8 sites in Italy, Switzerland
- Volunteers
- 411 people
- Sponsor
- Medtronic Italia
High Bleeding Risk, Coronary Artery Disease
Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with…
- Conditions
- High Bleeding Risk, Coronary Artery Disease, PCI
- Trial name
- MASTER DAPT (NCT03023020)
- Testing
- Aspirin, P2Y12 inhibitor
- Where
- 138 sites in Argentina, Australia and 28 more
- Volunteers
- 4,579 people
- Sponsor
- ECRI bv
Coronary Artery Disease
A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
The purpose of this trial 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 Clear (NCT03647475)
- Testing
- Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
- Where
- 4 sites in United States
- Volunteers
- 752 people
- Sponsor
- Medtronic Vascular
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
Atherosclerosis, Cardiovascular Disease
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.
- Conditions
- Atherosclerosis, Cardiovascular Disease, Hypercholesterolemia
- Trial name
- HEART-3 (NCT07839936)
- Testing
- VERVE-102
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- Verve Therapeutics, Inc.
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.
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.