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NCT04695106
More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI. This is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months. We expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.
NCT04723186
This is an open-label, sequential-dose escalation/de-escalation trial testing 3 dose levels of MT1002 in patients undergoing PCI due to ACS with NSTEMI. Three doses of MT1002 will be sequentially tested in cohorts of 6 patients each to achieve target ACT.
NCT06091319
The Primary Objective is to determine if a new nuclear tracer (named 18F-Florbetaben) used with nuclear imaging (PET imaging) can detect inflamed plaque in patients with recent ACS or stroke/TIA.
NCT03331484
Currently, there is minimal data on the combination of rivaroxaban and ticagrelor in patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI). Furthermore, there exists significant controversy among physicians in the use of oral anticoagulants in conjunction with antiplatelet therapy in this population. The present recommendation is triple therapy (aspirin + clopidogrel + warfarin), which has been related to major bleeding complications. Previous studies have shown that ticagrelor has been proven to be more effective in reducing the rate of death, new heart attacks, or strokes than the previously recommended drug, clopidogrel, and studies have shown that less bleeding occurs with rivaroxaban than with warfarin. Therefore, it would be ideal to investigate the two potent drugs, ticagrelor and rivaroxaban, in combination in order to gain insight in the management of these high-risk patients. The CAPITAL PCI AF study is a phase 3 Health Canada regulated interventional study involving the use of investigational drugs. It is a non-randomized, open-design study. The investigational team is studying the highly potent drug Ticagrelor, which is prescribed to participants receiving a stent placement, given in combination with Rivaroxaban, an oral anticoagulant recommended for patients with AF. The primary clinical endpoint is a safety outcome measuring bleeding complications in participants with AF treated within one year of the index PCI. The primary efficacy endpoint is measured by the clinical outcomes of death, stroke, non-central nervous system systemic embolism, myocardial infarction, and stent thrombosis within one year of the index PCI.
NCT04008173
ISACS ARCHIVES network is part of ISACS TC (NCT01218776) health care program. It is a collaborative network of research centers that support the rapid development of new scientific information and analytic tools. The ISACS ARCHIVES network assists health care providers, scientists, and policymakers seeking unbiased information about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and services, particularly prescription medications and medical devices in acute coronary syndromes (ACS).
NCT07548554
Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide. IHD develops as a result of reversible or irreversible impairment of myocardial perfusion in acute or chronic settings. This perfusion abnormality most commonly arises from compromise of epicardial coronary artery patency due to stenosis, occlusion, or vasomotor abnormalities. Structural and/or functional alterations in the microcirculation may also contribute to impaired myocardial perfusion. Conditions in which myocardial perfusion is acutely compromised are classified as acute coronary syndromes (ACS), whereas reversible ischemia developing on a chronic basis is evaluated under the umbrella of chronic coronary syndromes (CCS). In the assessment of epicardial (macrovascular) or microvascular pathologies leading to ischemia in CCS, angiography, a macroscopic lumenographic method, is often insufficient. Intracoronary pressure and flow measurements are required to determine the impact of angiographically detected epicardial lesions on coronary blood flow, perfusion pressure, and consequently myocardial perfusion. These measurements are referred to as invasive intracoronary physiology (IIP). Current guidelines recommend that decisions regarding revascularization of intermediate epicardial lesions should be based on IIP. Revascularization guided by IIP is associated with reduced mortality and morbidity, along with a lower stent burden. IIP can be performed using pressure-based, flow-based, or combined strategies. Recent multinational studies indicate that strategies integrating both flow and pressure parameters achieve better clinical outcomes with fewer interventions and reduced stent implantation compared to pressure-only approaches. Indeed, in cases where coronary flow and flow reserve are preserved, abnormalities in pressure parameters alone may not justify revascularization. Nevertheless, lesions deemed not to be associated with reversible ischemia based on IIP may still pose a risk due to plaque erosion/rupture and subsequent thrombotic cascades that can acutely compromise the lumen. Many acute coronary syndromes arise from lesions that are hemodynamically insignificant (i.e., do not affect flow) and unrelated to reversible ischemia in the CCS setting, but which undergo sudden near-total or total occlusion. The histopathological characteristics of any coronary lesion can be evaluated using intracoronary imaging techniques. Intracoronary Optical Coherence Tomography (IC-OCT) is a high-resolution, real-time imaging modality that quantitatively assesses lipid-rich plaque content, evaluates the thickness and stability of the fibrous cap separating this content from the lumen, and provides detailed information regarding minimal lumen area, lesion morphology, surface characteristics, presence of erosion, and plaque vulnerability to rupture. IC-OCT can identify lesions that are hemodynamically insignificant yet may benefit from revascularization and have the potential to cause ACS. Combined evaluation using IC-OCT and IIP enables an integrated assessment of both the relationship with chronic reversible perfusion impairment and the risk of precipitating ACS for each lesion and coronary segment, thereby facilitating optimal revascularization strategies. Despite the available evidence and guideline recommendations in CCS, the use of IC-OCT and IIP in the context of ACS remains limited due to procedural challenges and variability in practical application. These methods are not routinely recommended in guidelines and, in some cases, are even discouraged. However, the optimal strategy for revascularization of non-culprit lesions in ACS remains uncertain, and no consensus has yet been established. Patients with ACS are at increased risk for recurrent events arising from all coronary lesions. Therefore, accurate evaluation and preventive revascularization strategies for these lesions are expected to provide substantial benefit. Our study aims to reclassify and characterize non-culprit lesions in patients with ACS using combined IC-OCT and IIP assessment.
NCT07329699
The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.
NCT07422688
The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS
NCT07514988
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
NCT06845826
The goal of this study is to evaluate whether a POC-guided testing strategy to exclude non-ST elevation myocardial infarction (NSTEMI) in acute chest pain patients presenting at the emergency department (ED) can result in a shorter length of stay compared to the routine central laboratory testing strategy. Currently, most often two high-sensitivity troponin (hs-cTn) tests are required for exclusion of NSTEMI, and central laboratories are struggling to achieve the recommended turnaround time of 60 minutes. Novel POC hs-cTn testing technology can provide results in minutes, potentially reducing the ED length of stay. This may lead to a reduction in ED crowding, which is a growing worldwide healthcare problem, resulting in poorer patient outcomes. This study may therefore improve patient burden, ED staff workload, and lead to more efficient expenditure of healthcare resources. We will perform a prospective, cross-sectional, interventional, single-center, open label, randomized trial. All consecutive patients older than 18 years and younger than 75 years presenting at the UZ Leuven emergency department with chest pain or chest pain-equivalent symptoms suspected of an acute coronary syndrome (ACS) will be invited to participate in the study. After informed consent patients will be randomized into the point-of-care testing (POCT) group or the usual care group. Patients in the POCT group will undergo the novel POC test-guided strategy. In the POC strategy the first hs-cTnI test shortly after admission to the ED will be performed on the POC Atellica VTLi. The second test will be performed with the usual central laboratory hs-cTnT test. Patients in the usual care group will undergo the usual testing strategy with one or two hs-cTnT tests performed in the hospital's central laboratory.
NCT07449429
This study develops and validates a privacy-preserving OCR-LLM pipeline that converts admission history of present illness (HPI) records into structured coronary syndrome subtypes (STEMI, NSTEMI, unstable angina, and chronic coronary syndrome). The system first extracts text from de-identified HPI images using locally deployed OCR, then applies large language models with a fixed diagnostic prompt to generate subtype classification and evidence. Performance is evaluated in an internal validation cohort and multiple external datasets covering heterogeneous EHR templates, emergency department cases, and an English dataset from MIMIC-IV. A clinician usability study assesses changes in diagnostic accuracy and time with and without tool assistance.
NCT05726019
The present study seeks to evaluate the effectiveness of the use of perioperative colchicine with regard to operative complications, in patients with acute coronary syndrome and indication for cardiac post-surgical revascularization. Patients will be selected and randomized while still in the emergency room and medication (colchicine 0.5mg every 12 hours or placebo) will be started within 24 hours of randomization, being maintained for 30 days after surgery.
NCT07445581
The goal of this clinical trial is to learn if Tanhuo decoction works to treat acute coronary syndrome combined with cerebral atherosclerosis in the elderly. It will also learn about the safety of Tanhuo decoction. The main questions it aims to answer are: Can Tanhuo decoction reduce inflammatory markers in elderly patients with acute coronary syndrome combined with cerebral atherosclerosis and decrease the occurrence of adverse cardiovascular events? What medical problems do participants have when taking Tanhuo decoction? Researchers will compare Tanhuo decoction to a placebo (a look-alike substance that contains no drug) to see if Tanhuo decoction works to treat acute coronary syndrome combined with cerebral atherosclerosis in the elderly. Participants will:Take Tanhuo decoction or a placebo every day for a week. undergo laboratory tests and echocardiography at baseline (before starting the medication), on day 7, and at 1 month after initiation, and will complete telephone follow-ups during hospitalization and at 1, 3, 6, and 12 months after discharge.
NCT07436429
Drug-eluting stent (DES)-based primary percutaneous intervention (pPCI) has been established as the standard of care for patients presenting with ST-segment elevation myocardial infarction (STEMI), having demonstrated superiority over thrombolysis, plain balloon angioplasty, and bare-metal stents. Recently, the use of drug-coated balloons (DCB) has expanded dramatically across a variety of anatomical and clinical settings, including de novo coronary lesions. A DCB-based pPCI strategy may simplify the procedure and mitigate the risks of inadequate stent sizing due to spasm or large thrombus burden, acute stent thrombosis, distal embolization, no reflow, and the relatively higher incidence of late stent-related adverse events compared with elective PCI. Despite these theoretical advantages, data on the safety and efficacy of DCB-based pPCI in STEMI remains limited. The aim of this registry is to explore procedural and clinical outcomes of patients with STEMI treated with a DCB-based pPCI strategy.
NCT07440381
Early and intensive LDL-cholesterol (LDL-c) reduction is associated with improved short-term and long-term outcomes. Bempedoic acid is an oral ATP citrate lyase inhibitor that lowers LDL-c upstream of HMG-CoA reductase. When added to maximally tolerated statins, it has demonstrated significant LDL-c reduction and cardiovascular benefit, particularly in statin-intolerant or high-risk patients. However, evidence on early initiation of bempedoic acid during the index ACS hospitalization is currently lacking. The investigators therefore would like to see whether early (pre-discharge) initiation of an oral triple lipid-lowering therapy including bempedoic acid, high-intensity statin (HIS), and ezetimibe is superior to usual care in reducing LDL-c levels at 8 weeks after randomization in patients hospitalized for ACS.
NCT07276256
This study looks at people who come to the hospital with acute coronary syndrome, a serious heart condition. When these patients first arrive, doctors take routine blood tests. The investigators use these test results to calculate a value called the leukoglycemic index (LGI), which combines white blood cell count and blood sugar level. The investigators also use a heart imaging score called the SYNTAX score to see how complex their coronary artery disease is. Patients are divided into two groups based on their SYNTAX scores: one group with lower scores (22 or less), and one with higher scores (above 22). The investigators compare their health data to see if LGI is linked to the severity of their heart disease. The investigators also check if LGI can help predict how complex the disease is. Information like age, family history, and chronic illnesses is collected from patient records and medical interviews.
NCT07429227
The prospective experimental study aims to take an instantaneous photograph of the subject at time T0 and after 24 hours of intestinal permeability and dysbiosis indices in patients with acute coronary syndromes (ACS) which include unstable coronary artery disease (unstable angina) and acute myocardial infarction (AMI). The aim is to verify whether essential oils in particular formulations with high bioavailability are able to re-establish intestinal eubiosis after 2 months, confirmed by tests laboratory specifics such as metabolomics.
NCT01311323
MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS). Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction. In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE \<5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.
NCT07424482
Patients who are diagnosed with a heart attack are often confronted with an unexpected hospital admission and an urgent heart catheterization. In this stressful situation, anxiety is common and understanding of the procedure may be limited, even after standard verbal and written explanations. This study investigates whether a short educational video, shown in addition to standard medical information, can help patients better understand the heart catheterization procedure and reduce anxiety before the intervention. Patients will be randomly assigned to receive either standard information alone or standard information plus the educational video. The study will assess patients' understanding of the procedure, their level of anxiety, and their satisfaction with the information provided. The results may help improve patient education and support in acute cardiac care settings.
NCT06543082
The previous Mono Antiplatelet and Colchicine Therapy (MACT) pilot study (NCT04949516) demonstrated that it was feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after percutaneous coronary intervention (PCI) in addition to potent P2Y12 inhibitors in patients with acute coronary syndrome (ACS). However, the efficacy and safety of MACT have not yet been investigated. The goal of this clinical trial is to evaluate the clinical outcomes of ticagrelor P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS. The main questions it aims to answer are: * What is the frequency of the composite endpoint of cardiovascular death, nonfatal spontaneous myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding at 12 months post-intervention? * What is the frequency of stent thrombosis at 12 months post-intervention? For pre-specified analyses, researchers will compare MACT to less than 1 month, 3-month, and 12-month dual antiplatelet therapy (individual patient data from the T-PASS \[NCT03797651\] and TICO \[NCT02494895\] trials) to determine if MACT is effective in treating ACS. Participants will: * Take low-dose colchicine in addition to ticagrelor maintenance therapy, discontinuing aspirin the day after PCI. * Take a high-sensitivity C-reactive protein (hs-CRP) test 1 month after PCI. * Discontinue colchicine if the hs-CRP level is less than 2 mg/L, or continue colchicine if it is not. * Visit the clinic for check-ups at 1, 3, 6, 9, and 12 months after PCI.