[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659853":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":49,"studyPopulation":36,"armGroups":50,"interventions":65,"overallOfficials":77,"centralContacts":82,"locations":88,"responsibleParty":282,"collaborators":284,"id":288,"slug":289,"hasResults":290,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":36,"eligibilityCriteria":294,"healthyVolunteers":290,"sex":295,"minAge":296,"maxAge":36,"enrollmentInfo":297,"targetDuration":36,"studyType":300,"phases":301,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":312,"whyStopped":36,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":322},{"fullName":5,"class":6},"Ribocure Pharmaceuticals AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Primary objective","To evaluate the effect of vortosiran on change in coagulation Factor XI (FXI) activity","At week 16",{"measure":14,"description":15,"timeFrame":12},"Primary endpoint","Change in FXI blood coagulation activity.",[17,21,23,26,29,31,34],{"measure":18,"description":19,"timeFrame":20},"Secondary objective","To evaluate the safety, including the frequency and severity of bleeding events, with vortosiran, when administered subcutaneously as repeated doses, in participants with non-valvular AF, when compared to apixaban.","From screening until end of trial at week 64",{"measure":18,"description":22,"timeFrame":20},"To evaluate the safety, including the frequency and severity of bleeding events, with vortosiran, when administered subcutaneously to patients concomitantly taking apixaban, in participants with AF",{"measure":18,"description":24,"timeFrame":25},"Change in FXI blood coagulation activity","At week 64",{"measure":18,"description":27,"timeFrame":28},"To assess plasma exposure of vortosiran in participants with non-valvular AF","0 (pre-dose) to 24 hours after dosing",{"measure":18,"description":30,"timeFrame":25},"Number of participants with positive anti-drug antibodies (ADAs)",{"measure":18,"description":32,"timeFrame":33},"Change from baseline in APTT measurement throughout the trial period.","From baseline to week 64",{"measure":18,"description":35,"timeFrame":33},"Change and percent change compared with pre-dose baseline of PT-INR coagulation activity in each treatment group.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":36,"timePerspective":36,"maskingInfo":42},"RANDOMIZED","PARALLEL","This is a multicenter, randomised, actively controlled Phase IIb trial to evaluate the safety and pharmacodynamics (PD) of two blinded doses of subcutaneously administered vortosiran and open-label apixaban in patients with non-valvular atrial fibrillation (AF). The trial consists of three treatment arms with 50 participants each. The participants will be randomized in a 1:1:1 ratio to either the low-dose arm or the high-dose arm receiving vortosiran or matched placebo, with dosing on Day X and Day Y or to the treatment arm receiving apixaban as standard of care, with follow-up through Week 64.","TREATMENT",{"masking":43,"maskingDescription":36,"whoMasked":44},"QUADRUPLE",[45,46,47,48],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Atrial fibrillation (AF) is among the most prevalent cardiovascular conditions, affecting approximately 2 4% of the adult population worldwide. AF represents the most common sustained supraventricular arrhythmia and is associated with substantial morbidity, mortality, and health-care burden. Patients with AF are at an elevated risk of thromboembolic complications, particularly ischemic stroke and systemic embolism, while also facing an increased risk of bleeding associated with long-term antithrombotic therapy administered to prevent these complications. The principal aim of management in AF is to prevent stroke while minimizing haemorrhagic risk through careful risk stratification for both thromboembolic risk and bleeding risk, and informed and individualised treatment selections.\n\nAccording to current guideline recommendations, oral anticoagulation is recommended for stroke prevention and may be guided by CHA2DS2 -VASc clinical risk assessment tool. Nonvitamin K antagonist oral anticoagulants (NOACs, also referred to as direct oral anticoagulants, or DOACs) are preferred over vitamin K antagonists (VKAs) in most cases due to their superior safety profile and lower incidence of intracranial bleeding. Bleeding risk can be assessed using validated tools such as HAS-BLED, and modifiable risk factors should be addressed to reduce overall treatment-related complications.\n\nDespite a superior efficacy-safety profile of NOACs relative to VKAs, patients treated with NOACs remain at residual risk for stroke, systemic embolism, and cardiovascular mortality. Furthermore, although NOACs are associated with reduced rates of intracranial haemorrhage compared with VKAs, they still confer a considerable risk of major bleeding and clinically relevant non-major bleeding events. Consequently, the clinical need for strategies that further optimize the balance between thromboembolic prevention and bleeding risk in patients with AF remains.\n\nRecent advances have positioned coagulation factor XI (FXI) inhibition as a promising strategy in anti-thrombotic drug development. FXI is a crucial element of the intrinsic coagulation pathway, and genetic FXI deficiency (haemophilia C) is typically associated with only mild bleeding even in complete deficiency, suggesting the potential for improved safety compared to conventional anti-thrombotic drugs by disengaging physiologic haemostasis from pathologic, intraluminal thrombosis. FXI inhibition reliably prolongs activated partial thromboplastin time (APTT) in vitro, and epidemiological studies demonstrate that inherited FXI deficiency confers protection against venous thromboembolism (VTE) and ischemic stroke. Conversely, elevated circulating activated FXI (FXIa) is linked to higher risks of ischemic stroke, VTE, and acute coronary syndrome (ACS). Contemporary research utilizing coagulometric assays has confirmed FXIa and tissue factor activation in patients with stable coronary artery disease, ACS of less than 12 hours' duration, and heart failure, reinforcing FXI's role as a pathogenic factor in these conditions.\n\nFrom the patient perspective, the limitations of current DOAC-based strategies extend beyond rare catastrophic haemorrhage to include a spectrum of patient-relevant bleeding and treatment burdens that erode quality of life and adherence. Easy bruising, epistaxis, gingival bleeding, menorrhagia, and minor gastrointestinal bleeding are often labelled nuisance or non-major events in clinical trials, but patients describe these as anxiety-provoking, stigmatizing, and disruptive to daily activities. Such events, together with polypharmacy, twice-daily dosing for some agents, drug drug interactions, and the need for uninterrupted long-term therapy, frequently lead to missed doses, dose reductions, or unsupervised discontinuation of DOACs, which in turn compromises stroke protection at the population level. In parallel, important patient subgroups including those with advanced chronic kidney disease or dialysis, advanced liver disease, prior intracranial haemorrhage, or frailty have been underrepresented in pivotal DOAC trials and often withheld treatment or remain untreated because of bleeding concerns. By targeting FXI, vortosiran has the potential to dissociate pathological thrombosis from physiological haemostasis, and to deliver sustained antithrombotic protection with a lower risk bleeding than currently available therapies and an adherence profile that is better aligned with patients' priorities and lived experience.\n\nClinical trials targeting FXI inhibition in the context of cardiovascular disease, including AF, are ongoing or recently completed. Several Phase 2 and 3 trials are investigating FXI\u002FFXIa inhibitors by use of different modalities such as monoclonal antibodies and small molecules across multiple high-risk groups, evaluating efficacy and bleeding outcomes against standard anticoagulants for stroke prevention in AF (SPAF). These studies collectively support the notion that FXI\u002FFXIa may be a favourable anticoagulation target, capable of reducing thrombotic events with a lower side effect profile, especially bleeding, compared to traditional agents. However, while several trials confirm safety advantages, data on efficacy remain to be further demonstrated, necessitating continued research focus. Vortosiran is an N-acetyl galactosamine (GalNAc) conjugated small interfering ribonucleic acid (siRNA), enabling highly specific and highly durable enrichment of the siRNA in hepatocytes, offering a modality specifically inhibiting the production of FXI. Vortosiran is under development to achieve a durable antithrombotic effect by reducing the levels of FXI.\n\nThe rationale for the current trial is based on data from multiple Phase 2 and 3 studies of FXI\u002FFXIa inhibitors that have assessed FXI clotting activity and the effect on venous thrombosis inhibition, and is currently being tested for stroke prevention in atrial fibrillation patients. Based on the collective observations for these studies, that FXI clotting activity inhibition translates into a lower risk of thrombosis with a lower risk of bleeding compared to standard of care, the ongoing Phase 3 studies, and that vortosiran treatment can achieve identical or even higher degrees of FXI clotting activity inhibition, there is a rationale that vortosiran could potentially improve benefit-risk balance for stroke prevention in patients with atrial fibrillation compared to standard of care with FXa inhibitors.",[51,57,60],{"label":52,"type":53,"description":54,"interventionNames":55},"Low dose group receiving vortosiran.","ACTIVE_COMPARATOR","The low-dose group will receive two doses of vortosiran, the first dose at Day X and the second at Day Y. After 24 weeks, the participants will start an open-label part of the trial and receive apixaban until the end of the trial.",[56],"Drug: Vortosiran",{"label":58,"type":53,"description":54,"interventionNames":59},"High dose group receiving vortosiran.",[56],{"label":61,"type":53,"description":62,"interventionNames":63},"Group receiving apixaban","The third treatment group will receive apixaban during the entire trial.",[64],"Drug: Apixaban",[66,71,73],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":36},"DRUG","Vortosiran","Vortosiran, active drug",[52],{"type":67,"name":68,"description":69,"armGroupLabels":72,"otherNames":36},[58],{"type":67,"name":74,"description":75,"armGroupLabels":76,"otherNames":36},"Apixaban","Comparator, active drug",[61],[78],{"name":79,"affiliation":80,"role":81},"Anders Gabrielsen, MD, PhD","Ribocure Pharmaceuticals","STUDY_DIRECTOR",[83],{"name":84,"role":85,"phone":86,"phoneExt":36,"email":87},"Rebeckha Magnusson, Head Clinical Operations","CONTACT","+46 31 72 07 800","rebeckha.magnusson@ribocure.com",[89,105,118,133,141,157,170,183,196,209,222,233,243,257,270],{"facility":90,"status":36,"city":91,"state":36,"zip":36,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Frederiksberg Hospital","Frederiksberg","Denmark","DK",{"type":95,"coordinates":96},"Point",[97,98],12.53463,55.67938,{"lat":98,"lon":97},[101,103],{"name":102,"role":85,"phone":36,"phoneExt":36,"email":36},"Thomas Hermann, Doctor",{"name":102,"role":104,"phone":36,"phoneExt":36,"email":36},"PRINCIPAL_INVESTIGATOR",{"facility":106,"status":36,"city":107,"state":36,"zip":36,"country":92,"countryCode":93,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Herlev-Gentofte","Herlev",{"type":95,"coordinates":109},[110,111],12.43998,55.72366,{"lat":111,"lon":110},[114,117],{"name":115,"role":85,"phone":36,"phoneExt":36,"email":116},"Adam Ali Ghotbi, Doctor","adam.ali.holm.ghotbi@regionh.dk",{"name":115,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":119,"status":36,"city":120,"state":36,"zip":36,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Sykehuset Østfold Kalnes Kardiologisk","Grålum","Norway","NO",{"type":95,"coordinates":124},[125,126],11.06668,59.29048,{"lat":126,"lon":125},[129,132],{"name":130,"role":85,"phone":36,"phoneExt":36,"email":131},"Ole-Christian Rutherford, Doctor","ole-christian.rutherford@so-hf.no",{"name":130,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":134,"status":36,"city":135,"state":36,"zip":36,"country":121,"countryCode":122,"cosmosGeoPoint":36,"geoPoint":36,"contacts":136},"Akershus Universitetssykehus Ahus Kardiologisk","Lørenskog",[137,140],{"name":138,"role":85,"phone":36,"phoneExt":36,"email":139},"Henrik Schirmer, Doctor","henrik.schirmer@medisin.uio.no",{"name":138,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":142,"status":36,"city":143,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"EMC Silesia spółka z ograniczoną odpowiedzialnością","Katowice","Poland","PL",{"type":95,"coordinates":147},[148,149],19.02173,50.2597,{"lat":149,"lon":148},[152,155],{"name":153,"role":85,"phone":36,"phoneExt":36,"email":154},"Jaroslaw Rydzek","jaroslaw.rydzek@pentahospitals.pl",{"name":156,"role":104,"phone":36,"phoneExt":36,"email":36},"Jaroslaw Rydzek, Doctor",{"facility":158,"status":36,"city":159,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Centrum Medyczne Vitamedicum","Krakow",{"type":95,"coordinates":161},[162,163],19.93658,50.06143,{"lat":163,"lon":162},[166,169],{"name":167,"role":85,"phone":36,"phoneExt":36,"email":168},"Pawel Wrona, Doctor","pawel.wrona@vitamedicum.pl",{"name":167,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":171,"status":36,"city":172,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Balsam Medica Sp z o.o.","Raszyn",{"type":95,"coordinates":174},[175,176],20.9226,52.15603,{"lat":176,"lon":175},[179,182],{"name":180,"role":85,"phone":36,"phoneExt":36,"email":181},"Pawel Balsam, Doctor","pawel.balsam@me.com",{"name":180,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":184,"status":36,"city":185,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Aidport Clinical Trial Hospital","Skorzewo",{"type":95,"coordinates":187},[188,189],17.97006,54.16909,{"lat":189,"lon":188},[192,195],{"name":193,"role":85,"phone":36,"phoneExt":36,"email":194},"Magdalena Lanocha, Doctor","magdalena.lanocha@aidport.pl",{"name":193,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":197,"status":36,"city":198,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Centrum Medyczne LUX MED","Warsaw",{"type":95,"coordinates":200},[201,202],21.01178,52.22977,{"lat":202,"lon":201},[205,208],{"name":206,"role":85,"phone":36,"phoneExt":36,"email":207},"Piotr Pruszczyk, Professor","piotr.pruszczyk@wum.edu.pl",{"name":206,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":210,"status":36,"city":211,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Centrum Badań Klinicznych","Wroclaw",{"type":95,"coordinates":213},[214,215],17.03006,51.10286,{"lat":215,"lon":214},[218,221],{"name":219,"role":85,"phone":36,"phoneExt":36,"email":220},"Piotr Napora, Doctor","napora.piotr@cbk.wroc.pl",{"name":219,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":223,"status":36,"city":211,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":224,"geoPoint":226,"contacts":227},"Centrum Medyczne Oporów",{"type":95,"coordinates":225},[214,215],{"lat":215,"lon":214},[228,231],{"name":229,"role":85,"phone":36,"phoneExt":36,"email":230},"Tomasz Grzebieniak, Doctor","tomasz.grzebieniak@cmoporow.com",{"name":232,"role":104,"phone":36,"phoneExt":36,"email":36},"Tomasz Grzebieniak",{"facility":234,"status":36,"city":211,"state":36,"zip":36,"country":144,"countryCode":145,"cosmosGeoPoint":235,"geoPoint":237,"contacts":238},"Pracownia Badan Klinicznych Salus",{"type":95,"coordinates":236},[214,215],{"lat":215,"lon":214},[239,242],{"name":240,"role":85,"phone":36,"phoneExt":36,"email":241},"Maciej Rabczynski, Doctor","maciej.rabczynski@pbks.com.pl",{"name":240,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":244,"status":36,"city":245,"state":36,"zip":36,"country":246,"countryCode":247,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"Danderyds Sjukhus - Hjärtmottagningen","Danderyd","Sweden","SE",{"type":95,"coordinates":249},[250,251],18.02376,59.40398,{"lat":251,"lon":250},[254,256],{"name":255,"role":85,"phone":36,"phoneExt":36,"email":36},"Mika Skeppholm, Doctor",{"name":255,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":258,"status":36,"city":259,"state":36,"zip":36,"country":246,"countryCode":247,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"SUS Lund, Department of Cardiology","Lund",{"type":95,"coordinates":261},[262,263],13.19321,55.70584,{"lat":263,"lon":262},[266,269],{"name":267,"role":85,"phone":36,"phoneExt":36,"email":268},"David Erlinge, Professor","david.erlinge@gmail.com",{"name":267,"role":104,"phone":36,"phoneExt":36,"email":36},{"facility":271,"status":36,"city":272,"state":36,"zip":36,"country":246,"countryCode":247,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Södersjukhuset, Department of Cardiology","Stockholm",{"type":95,"coordinates":274},[275,276],18.06871,59.32938,{"lat":276,"lon":275},[279,281],{"name":280,"role":85,"phone":36,"phoneExt":36,"email":36},"Raffaele Scorza, Doctor",{"name":280,"role":104,"phone":36,"phoneExt":36,"email":36},{"type":283,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[285],{"name":286,"class":287},"LINK Medical Research AB","UNKNOWN","100659853","phase-2-vortosiran-in-atrial-fibrillation-100659853",false,"NCT07870889","Vortosiran in Atrial Fibrillation","A Randomised Active-controlled Trial to Assess the Safety and Pharmacodynamics of Two Blinded Doses of Vortosiran and Open-label Apixaban in Patients With Non-valvular Atrial Fibrillation (AF)","Inclusion Criteria:\n\n1. Adult male and female participants, age \\>\u002F=45 years.\n2. Documented diagnosis of non-valvular AF within 12 months of signing the informed consent (paroxysmal, persistent, or permanent) confirmed by ECG evidence (12-lead or other physician-confirmed electronic recording) and currently receiving continuous treatment with a DOAC for stroke prevention for at least the past 3 months.\n3. Capable of giving signed informed consent. Written informed consent must be obtained before any trial procedure is initiated.\n4. Postmenopausal women are eligible without additional contraceptive measures. Postmenopausal status is defined as:\n\n   * Age \\>\u002F=55 years with \\>\u002F=12 months of spontaneous amenorrhea, or\n   * Age \\\u003C55 years with \\>\u002F=12 months of spontaneous amenorrhea and follicle-stimulating hormone in the postmenopausal range, or surgical menopause (bilateral oophorectomy, with or without hysterectomy) documented in the medical history.\n5. Women of childbearing potential must agree to use highly effective contraception for the duration of trial treatment and for the specified post-treatment period.\n\nExclusion Criteria:\n\n1. AF due to a reversible cause (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism, alcohol use), participants in sinus rhythm after successful ablation or planned for cardioversion or ablation during trial conduct.\n2. Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral haemorrhage at any time in the absence of antithrombotic treatment.\n3. Any stroke within 14 days before randomisation or a transient ischemic attack within 3 days before randomisation.\n4. Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or trans vascular) during the course of the trial.\n5. Patients with a medical condition other than non-valvular AF for which chronic anticoagulation is indicated.\n6. Known presence of an atrial myxoma or left ventricular thrombus.\n7. History of or planned left atrial appendage closure or left atrial appendage removal.\n8. Uncontrolled hypertension (systolic blood pressure \\>\u002F= 160 mmHg or diastolic blood pressure \\>\u002F=100 mmHg) at randomization.\n9. Active bleeding, known bleeding disorder, or known anaemia that requires treatment or capillary Hgb \\\u003C100 g\u002FL.\n10. Any history of non-traumatic intracranial haemorrhage when not under treatment with an anticoagulant.\n11. Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or hepatic insufficiency classified as Child-Pugh B or C, or alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>2.5 x the upper limit of normal, measured between screening and randomisation.\n12. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 from the local lab, determined between screening and randomization.\n13. Major surgery during the last 30 days or planned major surgery or intervention with potential for uncontrolled bleeding within the trial period (e.g., carotid endarterectomy, coronary artery bypass grafting).\n14. Women who are pregnant, currently breastfeeding, or planning pregnancy during the trial or within the defined post-treatment period are not eligible.\n15. Known allergy, intolerance, or hypersensitivity to any of the trial interventions.\n16. Any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban.\n17. Anticipated need for chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs): Patients with chronic NSAID use, defined as systemic NSAID therapy on \\>\u002F=3 days per week for at least 4 consecutive weeks prior to screening, are excluded.\n18. Treated with a vitamin K antagonist within 3 months prior to screening.\n19. Patients with a diagnosis of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) at screening.\n20. Known current alcohol and \u002F or illicit drug abuse that may interfere with the participant's safety and \u002F or compliance at the discretion of the Investigator.\n21. Male participants who are not willing to use condoms when sexually active with a woman of childbearing potential who is not using highly effective contraception.\n22. Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical trial with investigational medicinal product(s) or device(s). Registries and observational studies are allowed.\n23. Any other condition or therapy that would make the participant unsuitable for the trial.","ALL","45 Years",{"count":298,"type":299},150,"ESTIMATED","INTERVENTIONAL",[302],"PHASE2","This is a randomised, actively controlled Phase IIb trial to evaluate the safety and pharmacodynamics (PD) of two blinded doses of subcutaneously administered vortosiran and open-label apixaban in patients with AF.\n\nThe trial consists of three groups including 50 participants each. The participants will be randomized to either the low dose group or the high dose group receiving vortosiran or to the group receiving apixaban. The treatment will be open-label for vortosiran vs apixaban. The vortosiran dose will be blinded to patients and investigators.\n\nBoth the low- and the high-dose group will receive two doses of vortosiran, the first dose at Day X and the second at Day Y. After 24 weeks, at the end of the vortosiran treatment period, the participants will start an open-label part of the trial and will be switched to standard-of-care apixaban treatment until Week 64 (End of Trial; EOT). Participants in the open-label apixaban arm will receive apixaban as standard of care during the entire trial.",[305],"Non-valvular Atrial Fibrillation (AF)",[307,308,309,310,311],"AF","Atrial fibrillation","siRNA","Phase 2","RCT","NOT_YET_RECRUITING","2026-10-06",{"date":315,"type":316},"2026-10-13","ACTUAL",{"date":318,"type":299},"2026-10-01",{"date":320,"type":299},"2028-08-31",{"name":5,"class":6},15]