[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-anticoagulation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-anticoagulation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,76],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100494880","carotid-implants-for-prevention-of-stroke-recurrence-from-large-vessel-occlusion-in-atrial-fibrillation-patients-treated-with-oral-anticoagulation-100494880",false,"NCT05723926","Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation","INTERCEPT","Inclusion Criteria:\n\n1. Documented history of clinical AF\n2. History of ischemic (i.e. non-hemorrhagic) stroke including symptoms of stroke resolving within 24 hours with positive neuro-imaging, meeting one of the following criteria:\n\n   Group 1: Patient was on OAC at time of index stroke, with index stroke occurring \\\u003C 6 week from enrollment Group 2: Patient was not on OAC at time of stroke, with index stroke occurring \\\u003C 6 weeks from enrollment Group 3: Patient was on OAC at time of index stroke, with index stroke occurring 6 to 52 weeks from enrollment\n3. Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial\n4. Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator\n5. Bilateral ultrasound or angiogram demonstrating all of the following:\n\n   1. Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm\n   2. Accessibility: up to 40 mm from skin to common carotid artery center\n   3. Implantation segment free of any atherosclerotic disease\n   4. Absence of carotid dissection or pre-existing stent(s) in common carotid artery\n   5. Absence of ≥50% stenosis of the internal carotid arteries as seen on ultrasound or angiography (CTA, MRA or DSA)\n\n   i. For ultrasound, calculate the percentage of carotid stenosis using the Society of Radiologists in Ultrasound Consensus Criteria for Carotid Stenosis, where ≥50% stenosis is defined by internal carotid artery peak systolic velocity of ≥125 cm\u002Fsec, internal\u002Fcommon carotid peak systolic velocity ratio of 2 or more and end diastolic velocity of ≥40 cm\u002Fsec, or evidence of near occlusion.\n\n   ii. For angiography, calculate the percentage of carotid stenosis using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (\\[D - N\\]\u002FD x 100, where N is the luminal diameter at the site of maximal narrowing and D is the diameter of normal distal internal carotid artery beyond the bulb where the artery walls are parallel.\n6. Provision of informed consent\n\nExclusion Criteria:\n\n1. Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)\n2. Contraindication to additional single antiplatelet therapy for 6 months from randomization\n3. Previously documented 50% or greater stenosis, or high-risk plaque in the opinion of the investigator, of the common carotid, internal carotid, subclavian, vertebral, or intracranial arteries that has not been treated with a revascularization procedure (i.e. stent or angioplasty)\n4. Visualized active (acute\u002Fsubacute) cervical or intracranial arterial thrombus (i.e. free-floating) on computed tomography (CT), magnetic resonance (MR), or digital subtraction (DS) angiography that is at risk of causing additional stroke\u002Fbrain injury\n5. Previously documented aneurysm of the internal carotid artery or its branches (i.e. ophthalmic, posterior communicating, anterior choroidal, anterior cerebral and middle cerebral arteries) that is 6 mm or greater in diameter.\n6. Prior surgery or radiation of the neck at the implantation segment\n7. Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke\n8. Planned left atrial appendage occlusion procedure\n9. Female who is pregnant or non-postmenopausal female who is not willing to use an effective method of birth control during duration of the trial\n10. Overt systemic infection\n11. Known sensitivity to nickel or titanium metals, or their alloys\n12. Active participation in another investigational drug or device treatment trial\n13. Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the trial","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","INTERVENTIONAL",[23],"NA","Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.",[26,27,28,29],"Atrial Fibrillation","Oral Anticoagulation","Stroke","Implant",[31,32,33,34],"Filter","Ischemic stroke","NOAC","LVO","RECRUITING","2026-06-07",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":39},"2026-01-09",{"date":43,"type":20},"2030-10-20",{"name":45,"class":46},"Javelin Medical","INDUSTRY",7,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100512662","phase-4-monotherapy-with-p2y12-inhibitors-in-patients-with-atrial-fibrillation-undergoing-supraflex-stent-implantation-100512662","NCT05955365","Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation","Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation","MATRIX-2","Inclusion Criteria:\n\n* Age ≥18 years\n* Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months\n* Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.\n* Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.\n* Written informed consent\n\nExclusion Criteria:\n\n* Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)\n* Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion\n* AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure\n* Prior mechanical valvular prosthesis implantation\n* Deep vein thrombosis\u002Fpulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation\n* Stroke within 1 month prior to randomization\n* Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and\u002For use of percutaneous left ventricular assist devices)\n* Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and\u002For diastolic BP ≥120 mmHg\n* Severe renal impairment with estimated creatinine clearance (CrCL) \\\u003C15 mL\u002Fmin or on dialysis\n* Moderate or severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy\n* Any hypersensitivity or contraindications for direct oral anticoagulation or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor\n* Any of the following abnormal local laboratory results prior to randomization: platelet count \\\u003C50 x109\u002FL or hemoglobin \\\u003C8 g\u002FdL\n* Known pregnancy or breast-feeding patients\n* Life expectancy \\\u003C1 year due to other severe non-cardiac disease\n* Planned surgery including coronary artery bypass grafting within the next 6 months",{"count":57,"type":20},3010,[59],"PHASE4","Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.\n\nThe currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.\n\nIn the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.\n\nIn this study the investigators would like to investigate whether treatment with a single antithrombotic drug (\"monotherapy strategy\") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications (\"standard-of-care strategy\").",[62,63,27,64],"Percutaneous Coronary Intervention (PCI)","Atrial Fibrillation (AF)","P2Y12 Inhibitor","2026-05-07",{"date":67,"type":39},"2026-05-08",{"date":69,"type":39},"2023-12-18",{"date":71,"type":20},"2028-06-30",{"name":73,"class":74},"Insel Gruppe AG, University Hospital Bern","OTHER",15,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":86,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100579374","advancing-knowledge-in-ischemic-stroke-patients-on-oral-anticoagulants-100579374","NCT06823466","Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants","Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry","ASPERA","Inclusion Criteria:\n\n* Age ≥18 years at the time of the index ischemic stroke.\n* Confirmed diagnosis of ischemic stroke according to the World Health Organization (WHO) definition.\n* Availability of at least one neuroimaging exam (either a non-contrast computed tomography \\[NCCT\\] or magnetic resonance imaging \\[MRI\\] of the brain) demonstrating one or more ischemic lesions consistent with patient symptoms.\n* Ongoing oral anticoagulation at the time of the index ischemic stroke, defined as the last intake within 48 hours prior to stroke symptom onset for patients on direct oral anticoagulants (DOACs), or an international normalized ratio (INR) of ≥1.5 in patients on vitamin K antagonists (VKAs), regardless of the time elapsed between the last intake and stroke symptom onset.\n* Prior diagnosis of AF or other cardioembolic arrhythmias.\n\nExclusion Criteria:\n\n* Symptoms not indicative of acute stroke (i.e., syncope, tonic or clonic activity, dizziness alone, confusion and amnesia alone, chronic or subacute development of focal neurological deficit).\n* Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging with heparin in patients initiating VKA.",{"count":85,"type":20},200,"5 Years","OBSERVATIONAL","The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences. The ASPERA study is a multicenter, observational, both retrospective and prospective real-world study involving acute ischemic stroke patients occurring on oral anticoagulation. The study will encompass a retrospective (ASPERA-R) and prospective (ASPERA-P) data collection. Patient will be recruited consecutively at different emergency services and stroke units worldwide. University of L'Aquila (UnivAQ) will be in charge of study coordination, data analysis and management. The duration of ASPERA-R will be of 5-year from the study initiation of the study. Participating centers will be given a 6-month timeframe to enter retrospective data, commencing from the date of study approval.\n\nASPERA-P duration will be of 2 years of enrollment from the study approval and follow-up of 5 years. (study conclusion after 7 years of approval). Inclusion criteria will be: 1.Confirmed diagnosis of ischemic stroke. 2. Availability of at least one neuroimaging exam positive for ischemic lesion(s) consistent with patient symptoms. 3. Ongoing oral anticoagulation at the time of the index ischemic stroke. 4. Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias. 5. Written informed consent provided by the patient himself or by proxy. Patients with Symptoms not indicative of acute stroke, ongoing intravenous or subcutaneous anticoagulation at the time of stroke will be excluded. ASPERA-R: characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. The primary outcome will be: ASPERA-R : characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. ASPERA-P: risk of ischemic stroke recurrence of ischemic stroke cases occurring on oral anticoagulants across different secondary preventive strategies (i.e., maintaining the same type of oral anticoagulation versus switching to a different secondary prevention strategy) at 90 days, 1 and 5 years after the index stroke. Additionally, the study will aim to investigate the risk of safety events (hemorrhagic transformation, intracranial hemorrhage, other major bleeding events, any bleeding events, death due to any cause), risk of other major ischemic events (transient ischemic attack, myocardial infarction, death due to vascular causes) at each follow-up and to identify demographic, clinical and neuroimaging features of ischemic stroke recurrences.",[90,27,63,91,92],"Ischemic Stroke","Outcome Assessment","Clinical Presentations",[32,94,95,96,97,98,99,100,101],"Oral anticoagulation","Atrial fibrillation","Direct oral anticoagulants","Vitamin k antagonists","Outcomes","Prognosis","Clinical characteristics","Secondary prevention","2025-02-17",{"date":104,"type":39},"2025-02-20",{"date":106,"type":39},"2025-02-12",{"date":108,"type":20},"2031-02-12",{"name":110,"class":74},"University of L'Aquila",47]