Clinical trials: High-risk Percutaneous Coronary Intervention
Acute Coronary Syndromes
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors With Statin for ACS Patients
Cardiovascular diseases (CVDs) remain the leading cause of death globally, with a dominant contribution from atherosclerotic CVD (ASCVD).
- Trial name
- NCT07736313
- Testing
- PCSK9 inhibitor plus rosuvastatin 20 mg tab, Rosuvastatin 20 Mg Oral Tablet
- Volunteers
- 120 people
- Sponsor
- Assiut University
Coronary Artery Disease
The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance
Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance
- Trial name
- EFFICIENT (NCT01032668)
- Testing
- Clopidogrel
- Where
- Turkey (Türkiye)
- Volunteers
- 192 people
- Sponsor
- Bursa Postgraduate Hospital
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
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
STEMI, Elevated IMR (>32)
A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving…
- Trial name
- RESTORE-MI (NCT03998319)
- Testing
- Tenecteplase (1/3 systemic weight based dose), Sterile water for injection (WFI)
- Where
- 22 sites in Australia, New Zealand
- Volunteers
- 445 people
- Sponsor
- University of Sydney
ST Elevation (STEMI) Myocardial Infarction
High-Dose Rosuvastatin Preloading for Enhanced Outcomes in STEMI Patients Undergoing Primary PCI
To compare the efficacy of high dose rosuvastatin preloading vs placebo before primary PCI in terms of MACE at 30 days
- Trial name
- HEROS-PCI (NCT06924684)
- Testing
- Statin monotherapy (rosuvastatin or atorvastatin)
- Where
- 2 sites in Pakistan
- Volunteers
- 66 people
- Sponsor
- Sheikh Zayed Federal Postgraduate Medical Institute
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
Acute Coronary Syndrome, Contrast-Induced Acute Kidney Injury
Predictors of Contrast-induced Acute Renal Injury in Patients With Acute Coronary Syndrome
This observational study aims to identify predictors of contrast-induced acute kidney injury (CI-AKI) in patients with acute coronary syndrome undergoing percutaneous coronary intervention.
- Trial name
- PC-AKI-ACS (NCT07294911)
- Testing
- Observational data collection
- Where
- Kazakhstan
- Volunteers
- 88 people
- Sponsor
- Karaganda Medical University
Coronary Stenoses
TAILored Versus COnventional AntithRombotic StratEgy IntenDed for Complex HIgh-Risk PCI
This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month…
- Trial name
- TAILORED-CHIP (NCT03465644)
- Testing
- Tailored antithrombotic strategy, Conventional antithrombotic strategy
- Where
- 22 sites in South Korea
- Volunteers
- 2,018 people
- Sponsor
- Duk-Woo Park, MD
Coronary Artery Disease
PMCF Study for Cardiology Access Procedures
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the…
- Trial name
- NCT05543096
- Testing
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Where
- 8 sites in Austria, Belgium
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Induced Acute Kidney Injury, High-risk Percutaneous Coronary Intervention
Protect Kidney Trial
This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to…
- Trial name
- NCT04321148
- Testing
- standard of care PCI, Impella-protected PCI
- Where
- Germany
- Volunteers
- 224 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Stable Angina Pectoris, Ad Hoc Percutaneous Coronary Intervention
Doubling the Maintenance Dose of Clopidogrel in Patients With High On-Clopidogrel Platelet Reactivity
The purpose of the study is to determine whether administration of 150 mg clopidogrel is effective in reducing the one-year incidence of thromboischemic events in patients with high on-clopidogrel platelet reactivity compared to…
- Trial name
- DOSER (NCT00638326)
- Testing
- clopidogrel
- Where
- Hungary
- Volunteers
- 500 people
- Sponsor
- University of Pecs
High Bleeding Risk, Coronary Artery Disease
Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous intervention with a…
- Conditions
- High Bleeding Risk, Coronary Artery Disease, Percutaneous Coronary Intervention
- Trial name
- ZEVS-HBR (NCT05240781)
- Testing
- Zotarolimus eluting stent, Sirolimus eluting stent
- Where
- Mexico
- Volunteers
- 280 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
Acute Coronary Syndrome (ACS), High On-treatment Platelet Reactivity (HTPR)
The Effect of IV Cangrelor and Oral Ticagrelor Study
Major heart attacks are caused by a number of factors, the two major of which are furring up of a coronary artery with atheroma and then sudden clot formation on this area leading to a blockage and interruption of blood flow.
- Conditions
- Acute Coronary Syndrome (ACS), High On-treatment Platelet Reactivity (HTPR), Microvascular Obstruction (MVO), ST-segment Elevation Myocardial Infarction (STEMI)
- Trial name
- NCT02733341
- Testing
- Cangrelor, Ticagrelor
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
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
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
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
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
Statin Dose
Effective Dose of Statin Post PCI
In this study post coronary stenting patients, were enrolled to receive moderate dose versus high dose statin for 1 year, and the result of major adverse cardiovascular events were recorded
- Trial name
- NCT04923152
- Testing
- moderate statin dose, high dose statin
- Where
- Iran
- Volunteers
- 582 people
- Sponsor
- Shiraz University of Medical Sciences