Clinical trials: High Ischemic Risk
Coronary Artery Disease, Percutaneous Coronary Intervention
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- DAPTLong (NCT06075433)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
Cardiogenic Shock, High Risk PCI
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
- Trial name
- NCT05820451
- Testing
- Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution
- Where
- 20 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abiomed Inc.
Prevention of Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: an acute stroke due to a blood clot that formed outside the…
- Conditions
- Prevention of Ischemic Stroke, Acute Non-cardioembolic Ischemic Stroke, High-risk Transient Ischemic Attack
- Trial name
- OCEANIC-STROKE (NCT05686070)
- Testing
- Asundexian (BAY2433334)
- Where
- 741 sites in United States, Argentina and 35 more
- Volunteers
- 12,327 people
- Sponsor
- Bayer
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.
Hypercholesterolemia
Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia
The purpose of this study is to determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to…
- Trial name
- NCT00654407
- Testing
- Rosuvastatin, Atorvastatin, Simvastatin
- Volunteers
- 4,875 people
- Sponsor
- AstraZeneca
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
Hypercholesterolemia, Coronary Heart Disease
Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at…
- Trial name
- NCT00770146
- Testing
- Mipomersen sodium
- Where
- 62 sites in United States
- Volunteers
- 158 people
- Sponsor
- Kastle Therapeutics, LLC
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
Left Ventricular Dysfunction, Coronary Artery Disease
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health…
- Trial name
- PROTECT IV (NCT04763200)
- Testing
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Where
- 110 sites in United States, Canada and 5 more
- Volunteers
- 1,252 people
- Sponsor
- Abiomed Inc.
Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI)
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients.
- Conditions
- Unstable Angina, Non ST Segment Elevation Myocardial Infarction (NSTEMI), Stable Angina (Associated With High Risk PCI)
- Trial name
- NCT01020383
- Testing
- ALX-0081, ReoPro®
- Where
- 39 sites in Austria, Belgium and 5 more
- Volunteers
- 364 people
- Sponsor
- Ablynx, a Sanofi company
Atherosclerosis
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated…
- Trial name
- CANTOS (NCT01327846)
- Testing
- Canakinumab, Standard of care
- Where
- 1,131 sites in United States, Argentina and 38 more
- Volunteers
- 10,066 people
- Sponsor
- Novartis Pharmaceuticals
Primary Prevention of Atherosclerotic Cardiovascular Disease
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at…
- Trial name
- NCT05739383
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- 983 sites in United States, Argentina and 40 more
- Volunteers
- 14,012 people
- Sponsor
- Novartis Pharmaceuticals
Coronary Heart Disease (CHD)
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a…
- Trial name
- VESALIUS-CV (NCT03872401)
- Testing
- Evolocumab
- Where
- 852 sites in United States, Argentina and 31 more
- Volunteers
- 12,301 people
- Sponsor
- Amgen
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 Artery Disease, Heart Failure
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients…
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Trial name
- NCT06754839
- Testing
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Volunteers
- 250 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Acute Coronary Syndrome, High Bleeding Risk
LEADERS FREE II: BioFreedom™ Pivotal Study
This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.
- Trial name
- NCT02843633
- Testing
- BioFreedom™ Drug Coated Coronary Stent System, Antiplatelet Drug
- Where
- 66 sites in United States, Canada and 5 more
- Volunteers
- 1,203 people
- Sponsor
- Biosensors Europe SA
Cardiovascular Diseases
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc.
- Trial name
- REDUCE-IT (NCT01492361)
- Testing
- AMR101, Statin therapy
- Where
- 410 sites in United States, Australia and 9 more
- Volunteers
- 8,179 people
- Sponsor
- Amarin Pharma Inc.
Coronary Artery Bypass Graft Surgery, Myocardial Ischemia
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
The purpose of this study is to determine whether MC-1 is effective and safe in reducing cardiovascular and neurological events in patients undergoing high-risk coronary artery bypass surgery
- Conditions
- Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury, Myocardial Revascularization
- Trial name
- NCT00157716
- Testing
- (MC-1) Pyridoxal-5'-phosphate
- Where
- 2 sites in United States, Canada
- Volunteers
- 900 people
- Sponsor
- Medicure
Coronary Artery Disease
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
- Trial name
- NCT05315544
- Testing
- CSI pVAD system
- Where
- Georgia
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)
- Trial name
- Vortex-FIH (NCT04674111)
- Testing
- Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
- Where
- 2 sites in Australia, Sweden
- Volunteers
- 5 people
- Sponsor
- Boston Scientific Corporation