Patients With High-risk Acute Coronary Syndrome Without ST-segment Elevation
Non ST Segment Elevation Myocardial InfarctionUnstable AnginaThis non-inferiority study aims at comparing Versa® to the reference enoxaparin (Clexane®, Sanofi-Aventis) in patients with high-risk unstable angina and NSTEMI. The main justification is the search for scientific evidence to prove the Versa® effectiveness for this new therapeutic indication, since it is a product with potential for reducing costs, with effectiveness and safety comparable to the reference drug.
Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)
Acute Coronary SyndromeMyocardial Infarction2 moreThe purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens. The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease. Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.
Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR...
ThrombosisCoronary Artery DiseasePersonalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting
Veliflapon (DG-031)to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack...
Acute Coronary SyndromeThe purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction.
Evaluation of the Effectiveness of Platelet-based and Microvesicle-based Assays to Predict Thrombotic...
Chronic Kidney Disease stage3This study is part of the RHU INNOV-CKD, winner of the 2019 call for projects. Its aim is to develop two biomarker assays to assess the thrombotic and haemorrhagic risks in patients with stage 3A or more severe chronic kidney disease (CKD) treated with percutaneous coronary intervention (PCI) and antiplatelet therapy following an acute coronary syndrome (ACS). We believe that these tests will help to adapt antiplatelet therapy on an individual basis (in terms of intensity and duration of treatment) and thus reduce the risk of thrombotic and haemorrhagic events in this particularly fragile population. The first biomarker corresponds to an intra-platelet molecule, Rap1b in its active form (known as aRap1b). The second is the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), which reflects endothelial dysfunction. An automated method for measuring these biomarkers will be developed in partnership with the D.Stago and BioCytex industries during the course of the project.
Score TO Predict SHOCK - STOP SHOCK
Cardiogenic ShockAcute Coronary Syndrome1 moreThe goal of this international multicenter study is to develop a scoring system to identify the risk of developing cardiogenic shock (CS) in patients suffering from acute coronary syndrome (ACS) utilising artificial intelligence. Study hypothesis: A complex machine learning (ML) model utilising standard patient's admission data predicts the development of cardiogenic shock in patients suffering from acute myocardial infarction better than standard prediction models. Study objectives: The primary objective of this study is to further improve predictive parameters of #STOPSHOCK model for prediction of development of cardiogenic shock in patients suffering from acute myocardial infarction. The secondary objective of this study is to develop a new predictive model for the development of cardiogenic shock in patients suffering from acute myocardial infarction based on larger combined cohort of patients utilising advanced ML algorithms, continuous model performance monitoring and continual learning.
'MInimalist' or 'MOre Complete' Strategies for Revascularization in Octogenarians
Multi Vessel Coronary Artery DiseaseIschemic Heart Disease4 moreOlder patients with co-morbidity are increasingly represented in interventional cardiology practice. They have been historically excluded from studies regarding the optimal management of NSTEACS. Though there are associated risks with invasive treatment, such patients likely derive the greatest absolute benefit from PCI. Small, though highly selective, studies suggest a routine invasive strategy may reduce the risk of recurrent myocardial infarction. The study aims to include, as far as possible, an 'all-comers' population of patients aged 80 and above to define the optimum amount of revascularization required to achieve good outcomes and satisfactory symptom relief for this challenging cohort of patients.
SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions
Acute Coronary SyndromeSTEMI - ST Elevation Myocardial Infarction1 moreThe aim of the registry is to investigate the clinical performance of the Magmaris Magnesium Stent in STE-ACS and NSTE-ACS patients.
Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery...
Acute Coronary SyndromeCoronary Artery DiseaseThis study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.
Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated...
Cardiac ArrestAcute Coronary SyndromeMild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.