Clinical trials: High-risk PCI
Bleeding Disorder, Ischemic Stroke
XIENCE 28 USA Study
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR)…
- Conditions
- Bleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases
- Trial name
- NCT03815175
- Testing
- XIENCE, DAPT (aspirin and/or P2Y12 receptor inhibitor)
- Where
- 111 sites in United States, Austria and 13 more
- Volunteers
- 1,605 people
- Sponsor
- Abbott Medical Devices
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
Coronary Heart Disease
Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients
To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple…
- Trial name
- CREATIVE (NCT01779401)
- Testing
- Clopidogrel 75mg, Clopidogrel 150mg, Aspirin 100mg
- Where
- 2 sites in China
- Volunteers
- 1,078 people
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
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
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
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
Cardiovascular Disease, Interventional Cardiology
Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention
The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot that could block blood flow to…
- Trial name
- TWILIGHT (NCT02270242)
- Testing
- Aspirin, ticagrelor
- Where
- United States
- Volunteers
- 9,006 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Coronary Artery Disease With Myocardial Infarction
Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention
The primary objective of the POST-PCI trial is to compare the clinical outcomes of a post-percutaneous coronary intervention(PCI) aggressive management strategy of routine noninvasive functional testing to a usual-care strategy…
- Trial name
- POST PCI (NCT03217877)
- Testing
- routine stress testing, No Routine stress testing
- Where
- 11 sites in South Korea
- Volunteers
- 1,700 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease, Heart Failure
PIONEER Trial:Hemodynamic Support With ECMO and IABP in Elective Complex High-risk PCI
To determine whether hemodynamic support combining VA-ECMO with IABP could mitigate the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCEs), compared with IABP support alone, in patients undergoing elective…
- Trial name
- NCT04045873
- Testing
- extracorporeal membrane oxygenation
- Volunteers
- 306 people
- Sponsor
- Xijing 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
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
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
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
Platelet Reactivity
High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI.
- Trial name
- NCT01835353
- Testing
- Prasugrel 100mg loading dose, Prasugrel 60mg loading dose
- Where
- Greece
- Volunteers
- 82 people
- Sponsor
- University of Patras
Patients Undergoing High Risk PCI.
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they…
- Trial name
- PROTECT I (NCT00534859)
- Testing
- High Risk PCI
- Where
- 10 sites in United States, Netherlands
- Volunteers
- 28 people
- Sponsor
- Abiomed Inc.
Acute Myocardial Infarction, Percutaneous Coronary Intervention
CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)
This study is intended to provide contemporary data on the residual cardiovascular risk in all consecutive patients with acute myocardial infarction, especially in patients who survived stably within one-year after percutaneous…
- Conditions
- Acute Myocardial Infarction, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events, Bleeding
- Trial name
- NCT02806102
- Testing
- Percutaneous coronary intervention, Dual-antiplatelet therapy
- Where
- 2 sites in South Korea
- Volunteers
- 13,000 people
- Sponsor
- Seoul St. Mary's Hospital
Coronary Artery Disease, Myocardial Infarction
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients
The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control…
- Trial name
- NCT06542575
- Testing
- DTx-guided HBCR
- Where
- China
- Volunteers
- 366 people
- Sponsor
- West China Hospital
Coronary Artery Disease
High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients
Dual antiplatelet therapy with Aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s) implantation.
- Trial name
- TRIPLETE RESET (NCT01543932)
- Testing
- Clopidogrel, Prasugrel, Ticagrelor
- Where
- Italy
- Volunteers
- 81 people
- Sponsor
- University of Roma La Sapienza
High-risk PCI
The PROTECT-EU Study
The PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP®…
- Trial name
- NCT05466552
- Testing
- PCI procedure
- Where
- Italy
- Volunteers
- 859 people
- Sponsor
- Fondazione GISE Onlus
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
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