Antithrombotic Therapy

Researchers are studying patients with elevated Lipoprotein(a) levels above 30 mg/dL who have undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation but have not experienced cardiovascular events or significant bleeding within 12 months after the procedure. The trial aims to compare whether extending dual antiplatelet therapy (DAPT) from the standard 12 months to 24 months can reduce major adverse cardiovascular and cerebrovascular events such as death, heart attack, and stroke. This randomized, double-blind trial also evaluates if longer DAPT is as safe as the standard duration regarding bleeding and net adverse clinical events. Participants are randomly assigned to one of two groups: one group receives aspirin combined with clopidogrel for 24 months after PCI, while the other group receives aspirin plus a placebo identical to clopidogrel for 12 months. The therapy is delivered as oral medications daily. The study includes a follow-up period with assessments at 3, 6, 9, and 12 months after randomization to monitor outcomes. The trial is conducted across multiple centers with blinded evaluation of results. During the study, participants will undergo regular monitoring to assess cardiovascular events and bleeding incidents, including all-cause death, myocardial infarction, stroke, stent thrombosis, and various bleeding types classified by the Bleeding Academic Research Consortium. Data will be collected through clinical visits and evaluations at predefined intervals up to 12 months after randomization. The research team will analyze these measures to determine the efficacy and safety of extended DAPT in this high-risk population. The total study duration includes treatment and follow-up phases to ensure comprehensive outcome assessment.

Stroke is a leading cause of death worldwide, with acute ischemic stroke caused by reduced blood flow to the brain often due to embolism or atherosclerosis. This study compares two thrombolytic drugs, tenecteplase and alteplase, to evaluate their safety, effectiveness, and economic benefits in real-world clinical practice. The goal is to help tailor intravenous thrombolytic treatment to different patient profiles and guide clinicians in choosing the best therapy. Participants who qualify will receive either tenecteplase at 0.25 mg/kg (up to 25 mg) or alteplase at 0.9 mg/kg (up to 90 mg), depending on their clinical condition and preferences. This real-world, multicenter, open-label study includes assessments at baseline, 24, 36, and 72 hours after treatment, with follow-up visits on day 7 or before discharge, and again at 90 days. The study aims to monitor functional outcomes, safety events like brain hemorrhage, and economic costs associated with hospitalization and recovery. During the study, participants will undergo neurological evaluations including the modified Rankin Scale at 90 days to assess recovery, and safety monitoring for symptomatic brain hemorrhage within 36 hours. Additional assessments include stroke severity scores and stroke recurrence tracking. Costs of initial hospitalization and days spent at home within 90 days will also be recorded. The total follow-up period extends to about three months after enrollment to capture both clinical and economic outcomes.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the device's performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

Researchers are observing the safety of damoctocog alfa pegol, a medicine used to treat hemophilia A, a genetic bleeding disorder caused by missing clotting factor 8 (FVIII). This study focuses on Korean participants who are at least 12 years old and have previously used other hemophilia A treatments. The main goal is to learn more about the safety of this medicine when used in routine medical care. Participants receive damoctocog alfa pegol as prescribed by their doctors following usual clinical practices. The study does not provide the medicine directly, and no changes to healthcare or additional treatments are made for study purposes. Data collection happens continuously during a 36-week period as participants continue their regular clinic visits. During the study, researchers collect data from participants' health records and routine care without requiring extra visits or tests. They monitor for any medical problems, including adverse events, serious adverse events, and reactions related to the treatment. The study tracks bleeding episodes, medicine usage, and treatment choices over about eight months for each participant, providing real-world safety information.

Researchers are investigating the role of focal electrical activations in maintaining persistent atrial fibrillation (AF). The study evaluates a new mapping technique called RETRO-Mapping, designed to detect these focal activations during AF. This approach aims to better understand the mechanisms behind persistent AF and whether targeting these focal drivers can improve treatment outcomes compared to standard care. All participants will undergo a standard pulmonary vein isolation (PVI) procedure using advanced 3D electroanatomic mapping systems. After PVI, patients are randomly assigned to either a control group, which receives RETRO-Mapping without additional ablation, or an intervention group, where RETRO-Mapping is used to identify and ablate focal activation sites. The intervention includes mapping 30-second segments of the atria, ablating identified focal activations, and assessing changes in AF cycle length to evaluate treatment effects. Participants will be monitored through detailed intra-procedural measurements, including AF cycle length in the coronary sinus and left atrial appendage. The main outcome is the change in AF cycle length during the procedure, and a secondary outcome is freedom from AF one year after treatment. The study involves follow-up assessments and safety monitoring, with a total participation duration extending to at least one year to track long-term effects and recurrence.

Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of L'Aquila. The study has two parts: ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.

Researchers are studying patients who are admitted to the emergency department while taking oral anticoagulant medications, which include drugs like Acenocoumarol, Apixaban, Dabigatran, Fluindione, Rivaroxaban, and Warfarin. These medications are commonly used to prevent blood clots but are linked to serious side effects such as bleeding and thrombosis, which can lead to hospitalizations and even fatal outcomes. The study aims to better understand the characteristics of these patients, especially those experiencing adverse drug events related to their anticoagulant treatment. This observational study will collect data over 24 months from adult patients admitted to the emergency department who are on oral anticoagulant therapy. The research team will focus on identifying adverse drug events like traumatic and spontaneous hemorrhages, overdoses without symptoms, and new blood clots despite treatment. Researchers will also assess adherence to prescribing guidelines, explore causes of adverse events, and evaluate early health risks and economic impacts related to these complications. Participants will be followed during their emergency department visit, where detailed information about their anticoagulant use and any adverse events will be recorded. The study will analyze these data to describe the groups of patients on different oral anticoagulants and to characterize drug-related adverse events. The project will last a total of 36 months, including one year for data analysis after two years of data collection, aiming to improve understanding of the risks and outcomes for patients on anticoagulant therapy.

Researchers are evaluating the Agilis Radiofrequency (RF) Transseptal System to study its initial safety and performance in crossing the atrial septum for accessing the left atrium and left ventricle during cardiac electrophysiology and interventional cardiology procedures. This early feasibility study involves a first-in-human, acute setting without long-term follow-up visits. The research aims to assess both safety and procedure success during hospital stay. Participants will undergo a transseptal procedure using the Agilis RF TSP System, which employs a radiofrequency wire to cross the atrial septum. The study focuses on an acute procedure setting with monitoring through hospital discharge, with no additional follow-up visits required. The procedure intends to facilitate access for left atrial and left ventricular interventions. During the study, participants will be observed from the time of device insertion through discharge from the hospital. Researchers will measure the rate of serious adverse events related to the device or procedure and the success rate of transseptal access as determined by the physician. The total participation time covers the procedure and hospital stay, with safety monitored periprocedurally.

Researchers are investigating the use of aspirin combined with a P2Y12 inhibitor, known as dual antiplatelet therapy (DAPT), which is the standard treatment for patients undergoing percutaneous coronary intervention (PCI) with stent placement. The trial aims to compare a score-based decision-making method for determining DAPT duration against the usual care approach that does not use such risk scores. This study is a randomized, single-blind trial designed to provide direct evidence on whether using risk scores improves patient outcomes. The study will include 2788 patients aged 18 years and older who have undergone PCI with stent implantation. Participants will be randomly assigned to one of two groups: an algorithm-guided DAPT duration group where therapy length is decided based on the PRECISE-DAPT score, PCI complexity, and clinical condition, or a standard-of-care group where treatment duration is left to the operator's discretion. The algorithm group uses specific treatment plans based on risk scores and clinical presentation, with therapy lasting from 1 month up to 12 months followed by monotherapy. Participants will be monitored over one year to assess various outcomes including death, myocardial infarction, stroke, stent thrombosis, and bleeding events. The main measure is a composite of net adverse clinical events (NACE) occurring within one year. The study will also track adherence to therapy and other cardiovascular events. Safety and effectiveness will be evaluated to understand if the algorithm-guided approach better balances bleeding and ischemic risks compared to standard care.

Researchers are studying the safety of restarting direct oral anticoagulants (DOACs) after a major gastrointestinal (GI) bleeding event in patients who have a moderate to high risk of bleeding again or developing blood clots. This pilot study aims to evaluate a standardized plan for resuming DOACs based on the patient's risk of clotting, helping to guide treatment decisions. A parallel registry will also compare patients who participate in the study with those who do not to understand any differences and explore challenges in enrolling patients. The study divides patients into two groups based on their thrombotic risk. Patients at high thrombotic risk will restart DOACs within 7 days after clinical hemostasis following GI bleeding. Those at moderate thrombotic risk will restart DOACs between 7 and 14 days after clinical hemostasis. The exact timing is determined by the clinical care team, and the type and dose of DOACs are chosen by the patient and their physician. No placebo or randomization is involved in this study. Participants will be monitored for 18 months to assess recruitment and adherence rates. During the study, researchers will evaluate outcomes such as repeat endoscopy, hospital readmissions, bleeding events, stroke, embolism, venous thromboembolism, mortality, functional status, and quality of life within 90 days after resuming DOACs. The study involves regular follow-up exams and data collection to assess these safety and clinical outcomes over time.