Clinical trials: High-risk PCI, open to volunteers
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
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
Coronary Artery Disease
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to…
- Trial name
- DEBATE (NCT04814212)
- Testing
- Percutaneous coronary intervention using drug-coated balloon, Percutaneous coronary intervention using drug-eluting stent
- Where
- 14 sites in Finland, France and 2 more
- Volunteers
- 546 people
- Sponsor
- North Karelia Central Hospital
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
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
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, 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
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
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
Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR)
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy…
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07374718
- Testing
- IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy, Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
- Where
- China
- Volunteers
- 468 people
- Sponsor
- Shenyang Northern Hospital
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 26 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Coronary Artery Disease
Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study
This pilot study aims to evaluate whether a single dose of PCSK9 inhibitor administered after percutaneous coronary intervention (PCI) can improve long-term cardiovascular outcomes in patients with high post-PCI lipid core…
- Trial name
- HANYANG-PICK (NCT07084259)
- Testing
- PCSK9 inhibitor, Standard Lipid-Lowering Therapy
- Volunteers
- 352 people
- Sponsor
- Hanyang University Seoul Hospital
AMI
High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction
This observational study aimed to investigate the prognostic value of high-frequency QRS (HF-QRS) in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI), as well as its potential role in…
- Trial name
- NCT07138638
- Testing
- High-Frequency QRS
- Where
- China
- Volunteers
- 1,112 people
- Sponsor
- The Affiliated Hospital of Xuzhou Medical University
Coronary Artery Disease, Percutaneous Coronary Intervention
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Myocardial Infarction
- Trial name
- PROTECT-HBR (NCT04416581)
- Testing
- PPI, P-CAB 50
- Where
- 45 sites in South Korea
- Volunteers
- 3,320 people
- Sponsor
- Duk-Woo Park, MD
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
Ischemic Heart Disease, Coronary Artery Disease
Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE)
The aim of the SMART-CARE trial is to compare clinical outcomes between coronary CT angiography (CCTA) versus standard care as follow-up strategies in high-risk patients after percutaneous coronary intervention (PCI).
- Trial name
- SMART-CARE (NCT07009418)
- Testing
- Coronary CT Angiography (CCTA)
- Where
- 22 sites in South Korea
- Volunteers
- 3,500 people
- Sponsor
- Samsung Medical Center
ST-segment Elevation Myocardial Infarction (STEMI)
Efficacy of Thrombus Aspiration in Patients With Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized, Controlled, Single-Blind Clinical Trial
The goal of this clinical trial is to learn if adding standardized manual thrombus aspiration to primary percutaneous coronary intervention (PPCI) works better to improve heart health outcomes and protect long-term heart function…
- Trial name
- TRAP-MI (NCT07551700)
- Testing
- Manual Thrombus Aspiration, Primary Percutaneous Coronary Intervention (PPCI)
- Volunteers
- 6,760 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Atrial Fibrillation, Coronary Artery Disease
Antithrombotic Strategy for AF Patients With High Risk CAD
Anticoagulation therapy is recommended for patients with atrial fibrillation (AF) in order to prevent ischemic stroke and systemic embolism.
- Trial name
- ADAPT AFFIRM (NCT06866665)
- Testing
- Anticoagulation Monotherapy, Combination therapy
- Volunteers
- 1,400 people
- Sponsor
- Yonsei University
ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI)
Clinical Characteristics, Frailty, and Prognostic Predictors in Patients Aged 75 and Older With Acute Coronary Syndrome
This study will evaluate clinical characteristics, frailty, and predictors of prognosis in patients aged 75 years and older who are hospitalized with acute coronary syndrome (ACS).
- Conditions
- ST Elevation (STEMI) Myocardial Infarction, Non ST Elevation Myocardial Infarction (NSTEMI), Unstable Angina Pectoris
- Trial name
- NCT07366684
- Testing
- Percutaneous Coronary Intervention (PCI), Conservative Medical Therapy
- Where
- Serbia
- Volunteers
- 550 people
- Sponsor
- Clinical Center Niš
PCI, Coronary Arterial Disease (CAD)
Super High-pressure Balloon Versus Intravascular Lithotripsy to Prepare Severely Calcified Coronary Lesions
this trial aimed to evaluate the stent expansion through intravascular imaging (optical coherence tomography (OCT) \& intravascular ultrasound (IVUS)) among individuals underwent different preparation techniques ,then comparing…
- Conditions
- PCI, Coronary Arterial Disease (CAD), Calcified Coronary Lesions
- Trial name
- Shape (NCT07093788)
- Testing
- super high-pressure balloon, intravascular lithotripsy (IVL)
- Where
- 3 sites in China
- Volunteers
- 78 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University