[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anticoagulants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anticoagulants":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,82,104,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100423656","phase-4-antiplatelet-therapy-strategy-following-left-atrial-appendage-closure-100423656",false,"NCT04796714","AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE","APPENDAGE","Inclusion Criteria:\n\n* Male or female patients with LAAC indication according to \"Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé\" (CNEDiMTS) (National Commission for the Evaluation of Medical Devices and Health Technologies) guidelines\n* Age ≥ 18 years\n* Written informed consent provided by the patient\n* Heart team approval: multidisciplinary team including interventional cardiologists, neurologists and other physicians discussing the definitive contraindication for anticoagulation\n* Registration under social security system\n\nExclusion Criteria:\n\n* Minors\n* Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation\n* LAAC contraindication : left appendage thrombus\n* Major disease resulting in a life expectancy of \\\u003C 1 year\n* Severe and inherited bleeding disorder\n* Known hypersensitivity to aspirin and\u002For clopidogrel:\n\n  * Hypersensitivity to clopidogrel, acetylsalicylic acid, or one of the excipients or other nonsteroidal anti-inflammatory drugs (cross-reaction).\n  * Asthma or a history of asthma with or without nasal polyps induced by salicylates or substances of close activity, including nonsteroidal anti-inflammatory drugs.\n  * Evolving peptic ulcer or history of gastric hemorrhage or perforation after treatment with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.\n  * Any constitutional or acquired haemorrhagic disease.\n  * Patients with mastocytosis, in whom the use of acetylsalicylic acid can lead to severe hypersensitivity reactions (including circulatory shocks with flushing, hypotension, tachycardia and vomiting).\n  * Severe liver failure.\n  * Severe kidney failure (Creatinine light \\\u003C 30ml\u002Fmin).\n  * Uncontrolled severe heart failure\n* Contraindication to MRI: claustrophobia or inability to lie still for exam time, implantable pacemaker or defibrillator, intracorporeal metal foreign body (especially intraocular), intracranial metal clip, cochlear implant, cardiac valve prosthesis type Starr-Edwards pre 6000, or biomedical device type insulin pump or neurostimulator.\n* Guardianship\n* Curatorship\n* Pregnancy or child-bearing potential female\n* Woman of childbearing age who does not benefit from highly effective contraception (CTFG recommendation on highly effective contraceptive methods: oral, intravaginal or transdermal estrogeno-progestin contraception; progestin-based oral, injectable or implantable contraception; intrauterine device; hormonal intrauterine device; female sterilization (occlusion of the fallopian tubes))\n* Iode contraindication\n* Patient already participating in another category 1 interventional research\n* Patient in a period of exclusion relative to another research protocol.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.",[26,27,28,29,30],"Atrial Fibrillation","Atrial Appendage","Anticoagulants","Stroke","Platelet Aggregation Inhibitors",[32,33,34,35,36],"left atrial appendage","percutaneous closure","stroke","antiplatelet therapy","atrial fibrillation","RECRUITING","2026-06-08",{"date":40,"type":41},"2026-06-10","ACTUAL",{"date":43,"type":41},"2022-10-03",{"date":45,"type":20},"2027-05-03",{"name":47,"class":48},"University Hospital, Bordeaux","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100626880","catheter-ablation-plus-laao-versus-anticoagulation-in-frail-elderly-patients-with-atrial-fibrillation-100626880","NCT07441382","Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation","Randomized Controlled Trial - Catheter Ablation Combined With Left Atrial Appendage Occlusion Versus Catheter Ablation Combined With Oral Anticoagulation for Elderly Frailty Patients With Atrial Fibrillation: Comparison of Efficacy and Safety","CLEAR-AF","Inclusion Criteria: (1) Age ≥ 75 years. (2) Confirmed diagnosis of non-valvular atrial fibrillation (paroxysmal or persistent). (3) CHA2DS2-VASc score ≥ 3 (high risk of stroke) . (4) Procedure-related criteria: Sequential Group: Participants who have received catheter ablation for non-valvular AF within 90 to 180 days prior to randomization. One-stop Group: Participants who are scheduled to undergo clinically indicated catheter ablation within 10 days after randomization. (5) Judged by the investigator to be able to tolerate the defined antithrombotic drug regimen. (6) Suitable to undergo Transesophageal Echocardiography (TEE) or Pulmonary Vein Computed Tomography (CT). (7) Able and willing to sign the written informed consent form. (8) Willing to return for all scheduled follow-up visits and examinations. Exclusion Criteria: (1) Presence of thrombus in the left atrium or left atrial appendage identified on preoperative imaging (echocardiogram, pulmonary vein CT, etc). (2) Major bleeding event (per ISTH definition) within 14 days prior to randomization. Participants must be excluded if clinical sequelae persist or if interventions for the bleeding source are planned\u002Fpending, regardless of the time elapsed since the event. (3) Requirement for long-term oral anticoagulation (OAC) for reasons other than stroke risk reduction in AF (e.g., underlying hypercoagulable state) that would prevent OAC discontinuation post-device implantation. (4) Any cardiac or major non-cardiac intervention\u002Fsurgery (excluding AF ablation and cardioversion) performed within 30 days prior to, or scheduled within 60 days after randomization. This includes but is not limited to Percutaneous Coronary Intervention (PCI) or other cardiac ablations. (5) Life expectancy \\\u003C 2 years, malignancy, infectious endocarditis, uncontrolled infection, or physiological evidence of cardiac tamponade. (6) Clinical Frailty Scale (CFS) score of 1-3 (not frail) or 7-9 (severely frail\u002Fterminally ill). (7) Deemed unsuitable for long-term anticoagulation and\u002For antiplatelet therapy by the investigator due to bleeding risk, allergies, or other reasons. (8) Current participation in another clinical trial that interferes with this study, excluding mandatory government or purely observational registries. (9) Stroke or transient ischemic attack (TIA) within 60 days prior to randomization. (10) Documented myocardial infarction (NSTEMI or STEMI) within 90 days prior to randomization, regardless of intervention. (11) History of atrial septal defect (ASD) repair or presence of an ASD\u002FPatent Foramen Ovale (PFO) occluder. (12) Presence of a mechanical prosthetic valve in any position. (13) Participants of childbearing potential who are pregnant or planning pregnancy during the study period. (14) Medical or anatomical contraindications to percutaneous catheter-based interventions. (15) Documented NYHA Class IV heart failure. (16) History of surgical left atrial appendage (LAA) closure.\n\nTransthoracic Echocardiography (TTE) Specific Exclusions: (1) Low LVEF: Left ventricular ejection fraction (LVEF) \\\u003C 30%. (2) Presence of pericardial effusion with a circumferential echo-free space \\> 5mm. (3) Presence of high-risk PFO associated with an atrial septal aneurysm (ASA) with an excursion or length \\> 15mm. (4) Presence of high-risk PFO with a large shunt (defined as appearance of microbubbles within 3 cardiac cycles and\u002For a substantial count of microbubbles). (5) Presence of moderate or severe mitral stenosis (mitral valve area \\\u003C 1.5 cm2).","75 Years",{"count":60,"type":20},200,[62],"NA","Atrial fibrillation (AF) is the most common arrhythmia, significantly increasing the risk of stroke, heart failure, hospitalization and death in patients. Studies have shown that standardized anticoagulation can effectively reduce the risk of stroke by 64% and the risk of death by 26% in AF patients. Therefore, both European and American guidelines recommend standardized oral anticoagulation (OAC) as an important treatment strategy for stroke prevention in AF patients. However, the use of OAC may also increase the risk of bleeding in patients. Results from large AF anticoagulation randomized trials show that the annual risk of anticoagulation-related bleeding mortality is 2% to 3%. Therefore, according to the guidelines recommendations, assessing the bleeding risk is necessary in patients with anticoagulant indications.\n\nPercutaneous left atrial appendage occlusion (LAAO) is a device-based therapy that aims to prevent ischemic stroke in patients with AF. For patients with contraindications to long-term anticoagulation therapy, LAAO can be considered as an alternative strategy to oral anticoagulation (Class II B recommendation) to prevent ischemic stroke and thromboembolism. Multiple studies have shown that LAAO is non-inferior to warfarin and novel oral anticoagulants in stroke prevention for non-valvular AF patients. Age is not only a risk factor for stroke but also an important risk factor for bleeding. In the elderly population, especially those with frailty, the risk factors for both stroke and bleeding are often increased. Currently, there is insufficient evidence to support the use of OAC in frail elderly patients with relative anticoagulant contraindications. Therefore, elderly AF patients may be one of the potential beneficiary groups for LAAO. However, most previous clinical studies on LAAO were based on small sample sizes to analyze their safety and efficacy, and clinical data on the safety and efficacy of LAAO in this high-risk population of elderly AF patients are still limited. To address this, the study aims to conduct a multicenter randomized controlled trial to compare the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients with high bleeding risk, filling the gap in this research area.\n\nTo address these limitations, this multicenter randomized controlled trial is designed to evaluate the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients at high risk for bleeding. The primary objective of the study is to compare the 12-month incidence and time-to-occurrence of the composite clinical endpoint. This endpoint includes stroke\u002FTIA, systemic embolism, ISTH-defined major bleeding. By establishing these metrics within the first year, the study aims to fill the current void in clinical evidence and provide a standardized treatment strategy for high-risk elderly patients. In addition to the primary endpoints, the study will conduct a comprehensive long-term evaluation extending to 24 months post-procedure to assess the durability of both treatment strategies. Secondary objectives include the assessment of perioperative safety, specifically focusing on serious intraoperative complications and major adverse events occurring within the first seven days after the LAAO procedure. The trial will also measure long-term rhythm control by tracking the rate of freedom from AF recurrence at the one-year and two-year marks. Furthermore, the study seeks to verify the hypothesized superiority of the ablation-plus-LAAO strategy in reducing the specific burden of anticoagulation-related major bleeding and stroke.\n\nBeyond clinical safety and efficacy, the trial will analyze the practical aspects of the two interventions, including procedural success rates, operation duration, fluoroscopy time, and the total duration of hospitalization. A critical component of the research involves identifying specific risk factors associated with complications, with a specialized focus on how frailty scores influence procedural tolerance and long-term prognosis. The study will further explore how different types of AF respond to the LAAO strategy and assess the impact of each treatment on non-major bleeding events. Ultimately, the trial aims to determine which strategy offers a superior improvement in the overall quality of life for elderly patients, thereby optimizing future clinical guidelines.",[65,29,66,67,27,68,28],"Atrial Fibrillation (AF)","Hemorrhage","Frailty","Catheter Ablation",[26,70,29,66,28,67,71,72,68],"Left Atrial Appendage Closure","Aged","Randomized Controlled Trial","2026-06-05",{"date":38,"type":41},{"date":76,"type":41},"2026-03-24",{"date":78,"type":20},"2028-03-01",{"name":80,"class":48},"Guangdong Provincial People's Hospital",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":81},"100437499","comparison-between-direct-oral-anticoagulation-doac-interruption-and-doac-continuation-in-patients-undergoing-elective-invasive-coronary-angiography-or-percutaneous-coronary-intervention-100437499","NCT04977076","Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention","SLIM-2","Inclusion Criteria:\n\n* Patients aged \\>18 years using DOAC and undergoing elective ICA or PCI.\n* Provided signed informed consent\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\nAny of the following:\n\n* Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA)\n* Patients \\\u003C18 years old\n* Calculated creatinine clearance \\\u003C30 mL\u002Fmin\n* Patients simultaneously participating in another clinical trial\n* History or condition associated with increased bleeding risk, as listed below:\n\n  * Major surgical procedure within 30 days before the procedure\n  * Known inaccessible radial artery during previous procedure\n  * History of GI bleeding in the previous 6 months\n  * History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding\n  * Chronic bleeding disorder\n  * Known intracranial neoplasm, arteriovenous malformation, or aneurysm\n  * Known anemia with last measured haemoglobin value \\\u003C6 mmol\u002FL \\[9.67 g\u002FdL\\]\n  * Current pregnancy or breast-feeding\n  * Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine aminotransferase (ALT) \\>3 x the upper limit of normal.\n* Participation in another clinical trial",{"count":90,"type":20},1270,[62],"A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.",[26,94,28],"Coronary Artery Disease","2026-05-26",{"date":97,"type":41},"2026-05-29",{"date":99,"type":41},"2022-09-01",{"date":101,"type":20},"2027-12-31",{"name":103,"class":48},"Zuyderland Medisch Centrum",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":81},"100428595","phase-4-anticoagulation-profile-in-pregnant-women-treated-with-three-times-a-day-of-low-molecular-weight-heparin-lmwh-100428595","NCT04861103","Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)","Inclusion Criteria:\n\n* Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.\n* Participants must be age 18 or older.\n\nExclusion Criteria:\n\n* Women with multiples.\n* Women less than age 18\n* History of Heparin Induced Thrombocytopenia (HIT)\n* Allergy to enoxaparin",true,"FEMALE",{"count":113,"type":20},12,[23],"Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.",[117,28],"Pregnancy, High Risk","2025-10-27",{"date":120,"type":41},"2025-10-29",{"date":122,"type":41},"2020-10-01",{"date":124,"type":20},"2027-07-31",{"name":126,"class":48},"University of California, Irvine",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":81},"100572112","phase-2-a-study-of-direct-oral-anticoagulants-in-patients-with-painful-venous-malformations-with-localized-intravascular-coagulation-100572112","NCT06729034","A Study of Direct Oral Anticoagulants in Patients with Painful Venous Malformations with Localized Intravascular Coagulation","A Single-center Blinded Crossover Study Investigating the Efficacy of Apixaban in Patients with Painful Venous Malformations with Localized Intravascular Coagulation","AVA","Inclusion Criteria:\n\n* 1\\. Participant must be 18-85 years of age at the time of signing the informed consent form (ICF).\n\n  2\\. Participants who have simple VM with LIC. VM must be diagnosed by MRi and LIC is defined as d-dimer \\> 2 x upper reference area (21).\n\n  3\\. Patients must experience pain from the malformation, NRS ≥4. Pain is defined as local pain in the malformation, and the participant must have pain that inhibits daily activity or pain during nighttime that interferes with sleep.\n\n  4\\. Body weight over 50 kg. 5. Pregnancy test at time of inclusion must be negative 6. Capable of giving written informed consent\n\nExclusion Criteria:\n\n1. History of major bleeding, known disease of the GI tractus with risk of bleeding (ulcera, IBD, tumor), known hemostatic disorder\u002Fhemophilia, bariatric surgery or other condition resulting in impaired adsorption of drug, active cancer\n2. Lesion or condition if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities\n3. Current treatment with platelet inhibitor, any other anticoagulation treatment e.g. unfractionated heparin, low molecular weight heparin (dalteparin, enoxaparin), heparin derivates (fondaparinux), oral anticoagulants (warfarin, dabigatran, rivaroxaban, edoxaban), NSAIDs, cancer therapy with chemotherapy\n4. Current treatment with sirolimus\n5. Current treatment with azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole)\n6. Current treatment with HIV protease inhibitors (e.g., ritonavir)\n7. Weight \\\u003C50 kg\n8. Known hypersensitivity to the active substance or to any of the excipients listed in the SmPC.\n9. Impaired renal function (eGFR \\\u003C 50 ml\u002Fmin)\n10. Impaired liver function, INR \\> 1.3 or aminotransferases \\> 3 times upper limit\n11. Pregnancy or breastfeeding\n12. Low platelet count (\\\u003C100 x 109\u002FmL)\n13. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures","85 Years",{"count":137,"type":20},20,[139],"PHASE2","There are two parts of the study. In Part 1, the invesitgaotrs want to investigate whether treatment with apixaban improves pain and quality of life in patients with painful venous malformations The participants are randomized to different treatment orders of the two treatment periods with apixaban and placebo. Arm 1 starts apixaban followed by placebo and arm 2 starts with placebo followed by apixaban. Between the treatment sequences there will be a washout period of minimum one week.\n\nThe participants will register pain and use og pain medication in a diary every day for one week before start of treatment and before evaluation of effect. Also, a quality of life form will be filled out before each consultation.\n\nIn Part 2, the investigators will investigate long-term effect and safety of apixaban and reduce dose after 3 months to find the minimal effective dose.\n\nPart 2 includes participants from Part 1 study who experienced effect of treatment or who agree to continue apixaban treatment. Study start of Part 2 is at the end of Part 1. All participants receive the same dose of apixaban as in part 1 (5 mg twice daily), and after 3 months (visit 2) the dose is reduced to 2.5 mg twice daily.",[142,28],"Venous Malformation, Low Flow",[144,145,146],"apixaban","venous malformation","localized intravascular coagulation","NOT_YET_RECRUITING","2024-12-06",{"date":150,"type":41},"2024-12-11",{"date":152,"type":20},"2025-02-01",{"date":154,"type":20},"2031-12-31",{"name":156,"class":48},"Oslo University Hospital"]