[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217067":3,"trial-entities:NCT07217067":392,"trial-summary:NCT07217067":395},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":44,"secondary_outcomes":49,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":91,"locations":94,"central_contacts":381,"overall_officials":387,"references":390,"see_also_links":391},"NCT07217067","CPKN605A12201","A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation","A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation","RECRUITING","2027-09-09","2026-07","2026-07-31","2025-10-28","Novartis Pharmaceuticals","INDUSTRY",true,"A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation","A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation.",[19],"Atrial Fibrillation",[21,22,23],"Atrial fibrillation","Atrial fibrillation burden","Arrhythmia","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},165,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","PKN605","PKN605 is an oral formulation",[37,38],"PKN605 higher dose","PKN605 lower dose",{"type":40,"name":41,"description":42,"armGroupLabels":43},"OTHER","Placebo","Matching placebo",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Atrial fibrillation burden from ECG patch monitors","Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time","24 weeks",[50,53,56],{"measure":51,"description":52,"timeFrame":48},"Time from the date of randomization to first atrial fibrillation recurrence","Defined as the time (days) from the date of randomization to first atrial fibrillation recurrence",{"measure":54,"description":55,"timeFrame":48},"Presence of atrial fibrillation recurrence after randomization","Defined as presence of (or absence) of atrial fibrillation recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol approved method for ascertainment individually and as a composite",{"measure":57,"description":58,"timeFrame":59},"Pharmacokinetic Parameter: concentration","PKN605 plasma concentration","24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)","ALL","18 Years",null,false,{"inclusion":65,"exclusion":80,"raw_text":90},[66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Inclusions at Screening","Signed informed consent must be obtained prior to participation in the study","Male and female participants ≥ 18 years of age","History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation","At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator","One or more of the following:","AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months","CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)","Stable heart failure or with New York Heart Association class I or II symptoms","NT-proBNP level of 300 pg\u002FmL or higher on a local lab test within the last 12 months","On guideline-directed stroke prevention treatment, as confirmed by the Investigator","Participants must have a body mass index (BMI) ≥ 18 kg\u002Fm2. BMI is calculated as body weight (kg) divided by height (m) squared","Inclusions at Day 1","Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)",[81,82,83,84,85,86,87,88,89],"Exclusions at Screening","Permanent AF","Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)","Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)","History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.","Implanted pacemaker, defibrillator, or cardiac monitor","Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy","Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used","Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening","Inclusion Criteria:\n\n* Inclusions at Screening\n\n  * Signed informed consent must be obtained prior to participation in the study\n  * Male and female participants ≥ 18 years of age\n  * History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation\n  * At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator\n  * One or more of the following:\n* AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months\n* CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)\n* Stable heart failure or with New York Heart Association class I or II symptoms\n* NT-proBNP level of 300 pg\u002FmL or higher on a local lab test within the last 12 months\n\n  * On guideline-directed stroke prevention treatment, as confirmed by the Investigator\n  * Participants must have a body mass index (BMI) ≥ 18 kg\u002Fm2. BMI is calculated as body weight (kg) divided by height (m) squared\n* Inclusions at Day 1\n\n  * Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)\n\nExclusion Criteria:\n\n-Exclusions at Screening\n\n* Permanent AF\n* Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)\n* Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)\n* History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.\n* Implanted pacemaker, defibrillator, or cardiac monitor\n* Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy\n* Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used\n* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening",[92,93],"ADULT","OLDER_ADULT",[95,112,127,140,154,168,183,192,199,206,213,219,225,231,234,241,244,247,253,259,267,270,276,283,289,292,298,301,309,316,323,330,336,342,348,351,354,362,369,376],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"contacts":101,"geoPoint":109},"Cardiology Associates of North MS","Tupelo","Mississippi","38801","United States",[102,106],{"name":103,"role":104,"email":105},"Brittany Cook","CONTACT","Brittany.cook@nmhs.net",{"name":107,"role":108},"James Edgar Stone","PRINCIPAL_INVESTIGATOR",{"lat":110,"lon":111},34.25807,-88.70464,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":100,"contacts":117,"geoPoint":124},"Cooper University Hospital","Camden","New Jersey","08103",[118,122],{"name":119,"role":104,"phone":120,"email":121},"Ifeoluwa Onuoha","+1 856 342 2000","onuoha-ifeoluwa@cooperhealth.edu",{"name":123,"role":108},"Andrea Russo",{"lat":125,"lon":126},39.92595,-75.11962,{"facility":128,"status":8,"city":129,"state":129,"zip":130,"country":100,"contacts":131,"geoPoint":137},"Weill Cornell Medical Center","New York","10021",[132,135],{"name":133,"role":104,"email":134},"Penn Collins","gpc4001@med.cornell.edu",{"name":136,"role":108},"Jim Way Cheung",{"lat":138,"lon":139},40.71427,-74.00597,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":100,"contacts":145,"geoPoint":151},"Duke Univ Medical Center","Durham","North Carolina","27710",[146,149],{"name":147,"role":104,"email":148},"Jessalyn Davis","jessalyn.crews@duke.edu",{"name":150,"role":108},"Jonathan Piccini",{"lat":152,"lon":153},35.99403,-78.89862,{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":100,"contacts":159,"geoPoint":165},"Intermountain Medical Center","Murray","Utah","84107",[160,163],{"name":161,"role":104,"email":162},"Paden Hansen","paden.hansen@imail.org",{"name":164,"role":108},"Michael Cutler",{"lat":166,"lon":167},40.66689,-111.88799,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":100,"contacts":173,"geoPoint":180},"Swedish Heart and Vascular Clinic","Seattle","Washington","98122",[174,178],{"name":175,"role":104,"phone":176,"email":177},"Serena Risher","+1 206 386 6462","Serena.Risher@swedish.org",{"name":179,"role":108},"David Lam",{"lat":181,"lon":182},47.60621,-122.33207,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":188,"geoPoint":189},"Novartis Investigative Site","Calgary","Alberta","T2P 3C5","Canada",{"lat":190,"lon":191},51.05011,-114.08529,{"facility":184,"status":8,"city":193,"state":194,"zip":195,"country":188,"geoPoint":196},"Vancouver","British Columbia","V5Z 1M9",{"lat":197,"lon":198},49.24966,-123.11934,{"facility":184,"status":8,"city":200,"state":201,"zip":202,"country":188,"geoPoint":203},"Halifax","Nova Scotia","B3H 3A7",{"lat":204,"lon":205},44.64269,-63.57688,{"facility":184,"status":8,"city":207,"state":208,"zip":209,"country":188,"geoPoint":210},"Hamilton","Ontario","L8L 2X2",{"lat":211,"lon":212},43.25011,-79.84963,{"facility":184,"status":8,"city":214,"state":208,"zip":215,"country":188,"geoPoint":216},"London","N6A 5W9",{"lat":217,"lon":218},42.98339,-81.23304,{"facility":184,"status":8,"city":220,"state":208,"zip":221,"country":188,"geoPoint":222},"Newmarket","L3Y 2P6",{"lat":223,"lon":224},44.05011,-79.46631,{"facility":184,"status":8,"city":226,"state":208,"zip":227,"country":188,"geoPoint":228},"Toronto","M4N 3M5",{"lat":229,"lon":230},43.70643,-79.39864,{"facility":184,"status":8,"city":226,"state":208,"zip":232,"country":188,"geoPoint":233},"M5B 1W8",{"lat":229,"lon":230},{"facility":184,"status":8,"city":235,"state":236,"zip":237,"country":188,"geoPoint":238},"Montreal","Quebec","H1T 1C8",{"lat":239,"lon":240},45.50884,-73.58781,{"facility":184,"status":8,"city":235,"state":236,"zip":242,"country":188,"geoPoint":243},"H2X 1R9",{"lat":239,"lon":240},{"facility":184,"status":8,"city":235,"state":236,"zip":245,"country":188,"geoPoint":246},"H4A 3J1",{"lat":239,"lon":240},{"facility":184,"status":8,"city":248,"state":236,"zip":249,"country":188,"geoPoint":250},"Québec","G1V 4G5",{"lat":251,"lon":252},46.81228,-71.21454,{"facility":184,"status":8,"city":254,"state":236,"zip":255,"country":188,"geoPoint":256},"Sherbrooke","J1H 5N4",{"lat":257,"lon":258},45.40008,-71.89908,{"facility":184,"status":8,"city":260,"state":261,"zip":262,"country":263,"geoPoint":264},"Beijing","Beijing Municipality","100013","China",{"lat":265,"lon":266},39.9075,116.39723,{"facility":184,"status":8,"city":260,"zip":268,"country":263,"geoPoint":269},"100730",{"lat":265,"lon":266},{"facility":184,"status":8,"city":271,"zip":272,"country":263,"geoPoint":273},"Xi'an","223001",{"lat":274,"lon":275},34.25833,108.92861,{"facility":184,"status":8,"city":277,"zip":278,"country":279,"geoPoint":280},"Bad Homburg","61348","Germany",{"lat":281,"lon":282},50.22683,8.61816,{"facility":184,"status":8,"city":284,"zip":285,"country":279,"geoPoint":286},"Berlin","10787",{"lat":287,"lon":288},52.52437,13.41053,{"facility":184,"status":8,"city":284,"zip":290,"country":279,"geoPoint":291},"13353",{"lat":287,"lon":288},{"facility":184,"status":8,"city":293,"zip":294,"country":279,"geoPoint":295},"Hamburg","20099",{"lat":296,"lon":297},53.55073,9.99302,{"facility":184,"status":8,"city":293,"zip":299,"country":279,"geoPoint":300},"20246",{"lat":296,"lon":297},{"facility":184,"status":8,"city":302,"state":303,"zip":304,"country":305,"geoPoint":306},"Arnhem","Gelderland","6815 AD","Netherlands",{"lat":307,"lon":308},51.98,5.91111,{"facility":184,"status":8,"city":310,"state":311,"zip":312,"country":305,"geoPoint":313},"Maastricht","Limburg","6229 HX",{"lat":314,"lon":315},50.84833,5.68889,{"facility":184,"status":8,"city":317,"state":318,"zip":319,"country":305,"geoPoint":320},"Delft","South Holland","2625 AD",{"lat":321,"lon":322},52.00667,4.35556,{"facility":184,"status":8,"city":324,"state":325,"zip":326,"country":305,"geoPoint":327},"Goes","Zeeland","4462 RA",{"lat":328,"lon":329},51.50417,3.88889,{"facility":184,"status":8,"city":331,"zip":332,"country":305,"geoPoint":333},"Groningen","9713 GZ",{"lat":334,"lon":335},53.21917,6.56667,{"facility":184,"status":8,"city":337,"zip":338,"country":305,"geoPoint":339},"Veldhoven","5504 DB",{"lat":340,"lon":341},51.41833,5.40278,{"facility":184,"status":8,"city":343,"state":343,"zip":344,"country":343,"geoPoint":345},"Singapore","S308433",{"lat":346,"lon":347},1.28967,103.85007,{"facility":184,"status":8,"city":343,"zip":349,"country":343,"geoPoint":350},"119074",{"lat":346,"lon":347},{"facility":184,"status":8,"city":343,"zip":352,"country":343,"geoPoint":353},"169609",{"lat":346,"lon":347},{"facility":184,"status":8,"city":355,"state":356,"zip":357,"country":358,"geoPoint":359},"Brighton","East Sussex","BN2 5BE","United Kingdom",{"lat":360,"lon":361},50.82838,-0.13947,{"facility":184,"status":8,"city":363,"state":364,"zip":365,"country":358,"geoPoint":366},"Newcastle upon Tyne","Tyne and Wear","NE7 7DN",{"lat":367,"lon":368},54.97328,-1.61396,{"facility":184,"status":370,"city":371,"zip":372,"country":358,"geoPoint":373},"WITHDRAWN","Liverpool","L14 3PE",{"lat":374,"lon":375},53.41058,-2.97794,{"facility":184,"status":8,"city":214,"zip":377,"country":358,"geoPoint":378},"W12 0HS",{"lat":379,"lon":380},51.50853,-0.12574,[382,385],{"name":13,"role":104,"phone":383,"email":384},"1-888-669-6682","novartis.email@novartis.com",{"name":13,"role":104,"phone":386},"+41613241111",[388],{"name":13,"affiliation":13,"role":389},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":393,"biomarkers":394},[19],[],{"nct_id":4,"found":15,"summary":396,"prompt_version":406},{"design":397,"status":398,"heading":399,"summary":400,"follow_up":401,"word_count":402,"commitments":403,"compensation":404,"drugs_mentioned":405},"This is a randomized, placebo-controlled study where neither you nor the study team will know if you are receiving PKN605 or the placebo. It plans to include 165 participants.","completed","PKN605 for Atrial Fibrillation Study","This study is testing a new oral medication called PKN605 for people with atrial fibrillation (a type of irregular heartbeat). We want to see if PKN605 can reduce how often and how long you experience atrial fibrillation episodes. Participants will be randomly assigned to receive either PKN605 or a placebo (an inactive substance) for 24 weeks. We'll also be looking at the safety and how well your body handles PKN605. You might be able to join if you are 18 or older and have had at least two episodes of atrial fibrillation, with one happening recently. The current recruitment status is unclear.","You will have a final safety follow-up visit approximately one month after the 24-week treatment phase ends.",102,"You will have a screening period of up to 90 days, followed by 24 weeks of treatment. During treatment, you will visit the clinic about once a month, and your heart rhythm will be monitored with ECG devices.","Not stated in the trial record.",[34,41],"v2"]