Clinical trials: High-Risk Percutaneous Coronary Intervention
High Bleeding Risk, Coronary Artery Disease (CAD)
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing…
- Conditions
- High Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
- Trial name
- DEBORA (NCT04885816)
- Testing
- Drug Eluting Balloon (DEB), Drug Eluting Stents (DES)
- Where
- Mexico
- Volunteers
- 5 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR)
Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype.
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07354828
- Where
- China
- Volunteers
- 3,500 people
- Sponsor
- Shenyang Northern Hospital
Ischemic Heart Disease, Coronary Artery Disease
Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a…
- Trial name
- CHIP-BCIS3 (NCT05003817)
- Testing
- Percutaneous left ventricular unloading
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Myocardial Infarction, Statin Adverse Reaction
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.
- Conditions
- Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity
- Trial name
- ROSUZET-AMI (NCT04499859)
- Testing
- Ezetimibe 10mg + Rosuvastatin 5mg, Rosuvastatin 20mg
- Where
- 7 sites in South Korea
- Volunteers
- 3,548 people
- Sponsor
- Kiyuk Chang, MD,PhD
Acute Coronary Syndrome
High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay
High on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy.
- Trial name
- HOPEmultiPFA (NCT02699008)
- Testing
- Clopidogrel, Ticagrelor
- Where
- China
- Volunteers
- 477 people
- Sponsor
- Wuhan Asia Heart Hospital
Acute Coronary Syndromes
Impact of Clopidogrel Dose Adjustment According to Platelet Reactivity Monitoring in Patients With High on Treatment Platelet Reactivity Undergoing Percutaneous Coronary Intervention
Acute coronary syndromes are related to the development of a platelet derived thrombus on a ruptured coronary atheroma. Use of dual antiplatelet therapy aspirin-thienopyridine a significantly reduced the risk of major adverse…
- Trial name
- NCT01505790
- Testing
- PRASUGREL, Clopidogrel
- Where
- France
- Volunteers
- 187 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Bleeding, Coronary Artery Disease
Intravenous CAngrelor in High-bleeding Risk Patients Undergoing percutaneouS Coronary Intervention (ICARUS) Registry
The study will investigate the prevalence of high bleeding risk (HBR) features and will compare the clinical outcomes of HBR and non-HBR patients among those undergoing percutaneous coronary intervention and receiving cangrelor…
- Conditions
- Bleeding, Coronary Artery Disease, Myocardial Infarction
- Trial name
- ICARUS (NCT05505591)
- Testing
- Cangrelor
- Where
- 2 sites in Italy
- Volunteers
- 900 people
- Sponsor
- Universita degli Studi di Genova
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
Coronary Artery Disease, Coronary Disease
Dose-dependent Effect of Rosuvastatin on Long-term Clinical Outcomes After PCI
This study is a prospective, randomized, open-label, single-center trial designed to compare the 30 month-safety and efficacy between low-dose (5mg/dL) and high-dose (20mg/dL) rosuvastatin treatment for patients with coronary…
- Conditions
- Coronary Artery Disease, Coronary Disease, Cardiovascular Diseases
- Trial name
- ROSUVA-30 (NCT02859480)
- Testing
- Rosuvastatin 5mg, Rosuvastatin 20mg
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Korea University Anam Hospital
High-risk Percutaneous Coronary Intervention
Impella ECP Early Feasibility Study
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
- Trial name
- ECP EFS (NCT04477603)
- Testing
- Impella ECP
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
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
Percutaneous Coronary Intervention, High Bleeding Risk
Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes
Background. Randomized data on the optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) are lacking. Methods.
- Conditions
- Percutaneous Coronary Intervention, High Bleeding Risk, Acute Coronary Syndromes, Anticoagulant Therapy
- Trial name
- BRIGHT-HBR (NCT07383155)
- Testing
- Anticoagulant Therapy
- Volunteers
- 5,270 people
- Sponsor
- Shenyang Northern Hospital
Chronic Coronary Syndrome, Acute Coronary Syndromes
Optimal LDL-C Target in High-risk Patients After PCI
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and…
- Conditions
- Chronic Coronary Syndrome, Acute Coronary Syndromes, Percutaneous Coronary Intervention, High Risk Patient
- Trial name
- REC-SAFETARGET (NCT06821711)
- Testing
- Intensive LDL-C control, Conventional LDL-C control
- Where
- China
- Volunteers
- 12,000 people
- Sponsor
- Xijing Hospital
ECMO, High-risk PCI
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI).
- Trial name
- ECMO-READY (NCT06274411)
- Testing
- Standby cannulated ECMO, Prophylactic ECMO
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
STRATegy SUccesS in High-Risk PCI With Impella CP: Evaluation of Hemodynamic Protection in Complex PCI
STRATUS-PCI is a pilot clinical trial that compares two ways of running a small heart pump called Impella CP during a high-risk procedure to open blocked heart arteries (percutaneous coronary intervention, or PCI) in patients…
- Trial name
- STRATUS-PCI (NCT07588399)
- Testing
- Impella CP
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Rayyan Hemetsberger
Coronary Artery Disease
The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg)…
- Trial name
- NCT00407771
- Testing
- Tirofiban
- Where
- Jordan
- Volunteers
- 44 people
- Sponsor
- Jordan Hospital
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
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
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
Coronary Artery Disease Requiring Coronary Revascularization With Newer Generation DES Implantation
Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial
This study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary…
- Trial name
- NCT05782777
- Testing
- ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg), high-intensity statin monotherapy (atoravastatin 40mg)
- Where
- South Korea
- Volunteers
- 4,310 people
- Sponsor
- Yonsei University