Clinical trials: High Risk Percutaneous Coronary Intervention
Platelet Reactivity
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)
The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting.
- Trial name
- NCT01463150
- Testing
- Clopidogrel, Prasugrel
- Where
- Greece
- Volunteers
- 27 people
- Sponsor
- University of Patras
Acute Coronary Syndrome, Hyperlipidemias
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on…
- Conditions
- Acute Coronary Syndrome, Hyperlipidemias, Percutaneous Coronary Intervention, Cardiovascular Events
- Trial name
- SHAWN (NCT05457582)
- Testing
- PCSK 9 Inhibitor plus high-intensity statin
- Where
- China
- Volunteers
- 1,212 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Shock, Cardiogenic, High Risk Percutaneous Coronary Interventions
Synchronized Cardiac Assist for Cardiogenic Shock
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous…
- Trial name
- NCT02697006
- Testing
- i-cor Synchronized Cardiac Assist Device
- Where
- Germany
- Volunteers
- 47 people
- Sponsor
- Xenios AG
Coronary Artery Disease, Percutaneous Coronary Intervention
Adjunctive Cilostazol Versus High Maintenance-dose Clopidogrel According to Cytochrome 2C19 Polymorphism
The purpose of this study is to determine the impact of adjunctive cilostazol versus high maintenance-dose clopidogrel on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 mutant allele.
- Trial name
- ACCEL-2C19 (NCT01012193)
- Testing
- cilostazol 100mg bid or clopidogrel 150-mg daily
- Where
- South Korea
- Volunteers
- 134 people
- Sponsor
- Gyeongsang National University Hospital
Coronary Artery Disease, Percutaneous Coronary Intervention
Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.
Patients who undergo percutaneous coronary intervention (PCI) are commonly treated with antiplatelet therapy to prevent stent thrombosis and recurrence of events.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndromes, Antiplatelet Therapy
- Trial name
- HI-TECH 2 (NCT07582835)
- Testing
- Clopidogrel, Ticagrelor, Prasugrel
- Where
- Switzerland
- Volunteers
- 355 people
- Sponsor
- Cardiocentro Ticino
Coronary Artery Disease (CAD)
Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy With Prasugrel (TRIGGER-PCI)
To determine the efficacy of prasugrel versus clopidogrel for the reduction of adverse cardiovascular outcomes in patients with high platelet reactivity on clopidogrel after successful implantation of coronary drug-eluting…
- Trial name
- TRIGGER-PCI (NCT00910299)
- Testing
- Prasugrel, Clopidogrel
- Where
- 27 sites in United States, Germany
- Volunteers
- 423 people
- Sponsor
- Eli Lilly and Company
ST Elevation Myocardial Infarction (STEMI), Malondialdehyde
Curcumin-Piperine Supplementation in STEMI - SPICE STEMI Trial
This study aims to evaluate whether supplementation with a combination of curcumin and piperine can help reduce inflammation and oxidative stress in patients who have experienced a heart attack called ST-Elevation Myocardial…
- Conditions
- ST Elevation Myocardial Infarction (STEMI), Malondialdehyde, Hs-CRP, Curcumin
- Trial name
- SPICE STEMI (NCT07149961)
- Testing
- Curcumin plus Piperine
- Where
- Indonesia
- Volunteers
- 50 people
- Sponsor
- Universitas Diponegoro
High-Risk Percutaneous Coronary Intervention
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or…
- Trial name
- NCT05334784
- Testing
- Impella ECP
- Where
- 32 sites in United States
- Volunteers
- 856 people
- Sponsor
- Abiomed Inc.
CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease
Efficacy of Phentolamine in Prevention of Contrast-Associated Acute Kidney Injury After Complex PCI
To evaluate the efficacy and safety of phentolamine in prevention of CA-AKI following complex PCI in patients at high risk of CA-AKI.
- Conditions
- CA-AKI - Contrast-Associated Acute Kidney Injury, Coronary Artery Disease, Acute Coronary Syndrome, Adrenergic Receptor Antagonist Adverse Reaction
- Trial name
- NCT06286059
- Testing
- Phentolamine
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Helwan University
Mitral Regurgitation
Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery
The primary objective in this randomized trial is to evaluate the safety and efficacy of a MitraClip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in…
- Trial name
- ISAR-CLIP (NCT01431222)
- Testing
- percutaneous treatment by implanting a Mitra Clip device
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), High Bleeding Risk
Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR
The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients…
- Trial name
- GUIDE-HBR (NCT06763744)
- Testing
- P2Y12 antagonist monotherapy, clopidogrel + aspirin
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease
Phitys I™ Percutaneous Left Ventricular Assist System Study
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
- Trial name
- NCT06357026
- Testing
- Percutaneous Ventricular Assist System（Phigine Medical）, intra-aortic balloon pump (IABP)
- Where
- 8 sites in China
- Volunteers
- 344 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
High Risk Percutaneous Coronary Intervention
HeartMate PHP™ CE Mark Clinical Investigation Plan
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable…
- Trial name
- HM PHP CE Mark (NCT02156609)
- Testing
- Percutaneous ventricular support with the HeartMate PHP
- Where
- 7 sites in Colombia, Netherlands and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Contrast-induced Nephropathy Following Percutaneous Intervention (CIN)
Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention
Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents.
- Trial name
- BEET-CIN (NCT06984406)
- Testing
- Beet-Derived Inorganic Nitrate-Based Food Product
- Where
- Russia
- Volunteers
- 88 people
- Sponsor
- National Medical Research Center for Therapy and Preventive Medicine
Ventricular Assist Device
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
- Trial name
- SUPPORT CE (NCT06565039)
- Testing
- Supira System
- Sponsor
- Supira Medical
Acute Kidney Failure
Clinical Trial of Sodium Bicarbonate to Prevent Contrast-Induced Nephropathy
The purpose of this study is to determine whether sodium bicarbonate is effective in the prevention of sodium-induced nephropathy
- Trial name
- NCT00424320
- Testing
- Sodium bicarbonate
- Where
- 2 sites in Mexico
- Volunteers
- 100 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction
Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease
Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD.
- Conditions
- Percutaneous Coronary Intervention (PCI), Acute Myocardial Infarction, Angina (Stable), Unstable Angina Pectoris
- Trial name
- ENDO-R (NCT06788275)
- Testing
- Aerobic exercise (MIT), Aerobic exercise (Short HIIT), Aerobic exercise (Long HIIT)
- Where
- 2 sites in Spain
- Volunteers
- 132 people
- Sponsor
- Instituto de Investigación Sanitaria y Biomédica de Alicante
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
Primary PCI for STEMI
Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the…
- Trial name
- NCT01472718
- Testing
- coronary thrombectomy, standard primary PCI (with stenting, as required)
- Volunteers
- 208 people
- Sponsor
- University of Pisa
ST-segment Elevation Myocardial Infarction (STEMI)
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy
This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis.
- Trial name
- BRIGHT-FIT (NCT06861374)
- Testing
- Bivalirudin, Unfractionated heparin
- Volunteers
- 2,400 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University