[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06909565":3,"trial-entities:NCT06909565":1997,"trial-summary:NCT06909565":2001},{"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":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":47,"secondary_outcomes":56,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":86,"locations":89,"central_contacts":1967,"overall_officials":1976,"references":1988,"see_also_links":1996},"NCT06909565","Pro00116826","Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention","Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)","RECRUITING","2029-12","2026-07","2026-08-28","2025-07-23","Duke University","OTHER",true,"V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.","CKJX839D1US04R is a pragmatic, randomized, double-blind, parallel group, placebo-controlled, multicenter, event-driven study evaluating inclisiran sodium 300 mg subcutaneous administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in participants presenting for elective or urgent percutaneous coronary or peripheral endovascular intervention (PCI or PVI). At the time of a successful revascularization procedure or up to 14 days following the procedure, participants will be randomized and administered the first dose of inclisiran or corresponding placebo in a 1:1 fashion, stratified by the type of index arterial revascularization procedure, either coronary (i.e., PCI) or lower extremity (i.e., PV).\n\nThe enrollment population will be representative of typical patients in the US with atherosclerotic cardiovascular disease, either coronary artery disease (CAD) or peripheral artery disease (PAD), and the trial endpoints are designed to be scientifically relevant and clinically meaningful to patients, clinicians, and other persons involved in the care of cardiovascular patients. The trial is designed to also understand how inclisiran therapy can be implemented in real-world clinical practice settings.\n\nThe expected enrollment of the trial is approximately 6,000 participants, randomized in a 1:1 fashion to receive inclisiran or placebo, within 14 days of successful percutaneous coronary or lower extremity peripheral endovascular intervention for symptomatic atherosclerotic cardiovascular disease (ASCVD).\n\nInclisiran sodium or corresponding placebo will be administered by s.c. injection to participants presenting for percutaneous coronary or peripheral endovascular intervention, in addition to usual care according to their individual medical history. All participants randomized to the treatment arm will receive inclisiran in addition to usual care per their regular physician direction, and those participants randomized to placebo will receive matching placebo, as well as usual care treatment, according to their treating physician.\n\nStudy duration is determined by event accrual consistent with the event-driven design, i.e., when approximately 2380 primary composite events have occurred and at least 50% of participants have at least 36 months of follow-up. Assuming 18 months of recruitment at a uniform rate, the last patients enrolled will have about 27 months of follow-up. Therefore, study duration should be approximately 4 years.\n\nThe study is event-driven, and thus, all participants will be treated (or followed in the case of permanent discontinuation of study drug) until the End of Study visit. As such, the planned duration of treatment cannot be stipulated for an individual participant. The estimated maximum treatment period for an individual participant is approximately 45 months, and the mean treatment duration is expected to be approximately 36 months.",[19,20],"Percutaneous Coronary Intervention","Peripheral Endovascular Intervention",[22,23,24,25,26,19,27],"inclisiran","Coronary Artery Disease","hypercholesterolemia","Cardiovascular Disease","Percutaneous Endovascular Intervention","PCSK9","INTERVENTIONAL","PREVENTION",[31],"PHASE4",{"count":33,"type":34},6000,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DRUG","Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL","300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; \\& every 6 months thereafter",[41],"Inclisiran Sodium",{"type":37,"name":43,"description":44,"armGroupLabels":45},"Normal Saline (Placebo)","Normal saline placebo subcutaneous injection given at Day 0, Day 90; \\& every 6 months thereafter",[46],"Placebo",[48,52],{"measure":49,"description":50,"timeFrame":51},"Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization","MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.","From randomization to first occurrence of MACE (up to approximately 4 years)",{"measure":53,"description":54,"timeFrame":55},"Total number of major adverse limb events (MALE) after endovascular revascularization","MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.","From randomization to first occurrence of MALE (up to approximately 4 years)",[57,60,63],{"measure":58,"timeFrame":59},"Number of participants with cardiovascular (CV) death","From randomization to CV death (up to approximately 4 years)",{"measure":61,"timeFrame":62},"Number of participants with all cause death","From randomization to all cause death (up to approximately 4 years)",{"measure":64,"timeFrame":65},"Number of participants with venous thromboembolic events (VTE)","From randomization to first VTE (up to approximately 4 years)","ALL","18 Years",null,false,{"inclusion":71,"exclusion":76,"raw_text":85},[72,73,74,75],"Signed informed consent must be obtained prior to participation in the study.","Males or females ≥ 18 years of age","Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD","Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention",[77,78,79,80,81,82,83,84],"Planned future PCI or PVI","Current or planned use of an open-label PCSK9 inhibitor during the study","Any prior treatment with inclisiran","Active or planned participation in another clinical study involving investigational drugs or devices during the study","Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results","Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities","Patients taking prohibited therapies as listed in Section 6.6.3","Pregnant or breast-feeding women","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Males or females ≥ 18 years of age\n* Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD\n* Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention\n\nExclusion Criteria:\n\n* Planned future PCI or PVI\n* Current or planned use of an open-label PCSK9 inhibitor during the study\n* Any prior treatment with inclisiran\n* Active or planned participation in another clinical study involving investigational drugs or devices during the study\n* Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results\n* Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities\n* Patients taking prohibited therapies as listed in Section 6.6.3\n* Pregnant or breast-feeding women",[87,88],"ADULT","OLDER_ADULT",[90,108,122,136,151,166,180,195,209,227,235,249,263,277,291,305,315,329,340,355,369,384,398,412,427,441,459,474,485,499,513,527,538,551,565,579,589,603,610,624,639,646,660,675,689,704,718,732,747,762,777,792,806,820,834,848,863,878,892,906,920,934,948,963,977,991,1006,1016,1030,1045,1059,1074,1089,1103,1113,1127,1142,1157,1171,1185,1199,1213,1227,1242,1257,1271,1281,1294,1308,1322,1336,1350,1365,1379,1390,1404,1418,1432,1446,1460,1474,1489,1503,1517,1531,1546,1561,1575,1589,1602,1616,1630,1645,1660,1675,1689,1703,1714,1728,1743,1754,1768,1775,1789,1803,1817,1831,1845,1858,1872,1882,1897,1910,1924,1939,1952],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":105},"Advanced Cardiovascular LLC","Alexander City","Alabama","35010","United States",[97,102],{"name":98,"role":99,"phone":100,"email":101},"Sabrina Forbus","CONTACT","256-215-5323","s.forbus.adv@gmail.com",{"name":103,"role":104},"Brian Foley, MD","PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},32.94401,-85.95385,{"facility":109,"status":8,"city":110,"state":93,"zip":111,"country":95,"contacts":112,"geoPoint":119},"Cardiology, PC","Birmingham","35211",[113,117],{"name":114,"role":99,"phone":115,"email":116},"Wesley Wade","205-780-4330","wwade@cardiologypc.com",{"name":118,"role":104},"Hutton Brantley, MD",{"lat":120,"lon":121},33.52066,-86.80249,{"facility":123,"status":8,"city":124,"state":93,"zip":125,"country":95,"contacts":126,"geoPoint":133},"Heart Center Research, LLC","Huntsville","35801",[127,131],{"name":128,"role":99,"phone":129,"email":130},"Cynthia Abath","256-519-8235","cabath@theheartcenter.md",{"name":132,"role":104},"Henry Chen, MD",{"lat":134,"lon":135},34.7304,-86.58594,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":95,"contacts":141,"geoPoint":148},"IMS Cardiology","Avondale","Arizona","85392",[142,146],{"name":143,"role":99,"phone":144,"email":145},"Kristen Sheehan","602.854.1583","kristen.sheehan@emverahealth.com",{"name":147,"role":104},"Riyaz Sumar, MD",{"lat":149,"lon":150},33.4356,-112.3496,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":95,"contacts":156,"geoPoint":163},"Cardiology Associates Research Group","Jonesboro","Arkansas","72401",[157,161],{"name":158,"role":99,"phone":159,"email":160},"Beth Morgan","1-870-207-3812","bmorgan@cargresearch.com",{"name":162,"role":104},"Ahmed Ahmed, MD",{"lat":164,"lon":165},35.8423,-90.70428,{"facility":167,"status":8,"city":168,"state":154,"zip":169,"country":95,"contacts":170,"geoPoint":177},"Arkansas Cardiology","Little Rock","72205",[171,175],{"name":172,"role":99,"phone":173,"email":174},"Bobbi Phillips","501-227-7596","bphillips@arcard.org",{"name":176,"role":104},"David Jones, MD",{"lat":178,"lon":179},34.74648,-92.28959,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":95,"contacts":185,"geoPoint":192},"Pacific Oaks Medical Group","Beverly Hills","California","90211",[186,190],{"name":187,"role":99,"phone":188,"email":189},"Victor Guerro","1-949-284-5715","vguerrero@pacificoaks.com",{"name":191,"role":104},"Ramprasad Dandillaya, MD",{"lat":193,"lon":194},34.07362,-118.40036,{"facility":196,"status":8,"city":197,"state":183,"zip":198,"country":95,"contacts":199,"geoPoint":206},"Cardiovascular Institute of San Diego","Chula Vista","91911",[200,204],{"name":201,"role":99,"phone":202,"email":203},"Jacob Pineda","1-619-616-2100","jacob.pineda@cvisd.com",{"name":205,"role":104},"Milind Parikh, MD",{"lat":207,"lon":208},32.64005,-117.0842,{"facility":210,"status":8,"city":211,"state":183,"zip":212,"country":95,"contacts":213,"geoPoint":224},"John Muir Medical Center - Concord Campus","Concord","94520",[214,218,222],{"name":215,"role":99,"phone":216,"email":217},"Rita Trachuk","1-925-674-2685","rita.trachuk@johnmuirhealth.com",{"name":219,"role":99,"phone":220,"email":221},"Bethany Wexler","1-925-674-2257","bethany.wexler@johnmuirhealth.com",{"name":223,"role":104},"Jason Liu, MD",{"lat":225,"lon":226},37.97798,-122.03107,{"facility":228,"status":229,"city":230,"state":183,"zip":231,"country":95,"geoPoint":232},"Valley Clinical Trials","WITHDRAWN","Covina","91723",{"lat":233,"lon":234},34.09001,-117.89034,{"facility":236,"status":8,"city":237,"state":183,"zip":238,"country":95,"contacts":239,"geoPoint":246},"Thrive Clinical Research Group","Glendora","91740",[240,244],{"name":241,"role":99,"phone":242,"email":243},"Tayler Flores","1-626-823-7095","tflores@thriveclinicalresearch.org",{"name":245,"role":104},"Fahed Bitar, MD",{"lat":247,"lon":248},34.13612,-117.86534,{"facility":250,"status":8,"city":251,"state":183,"zip":252,"country":95,"contacts":253,"geoPoint":260},"Radin Cardiovascular Medical Group, Inc","Newport Beach","92663",[254,258],{"name":255,"role":99,"phone":256,"email":257},"Morgan Stoaks","1-949-722-7555","morgan.rcmg@gmail.com",{"name":259,"role":104},"Michael Radin, MD",{"lat":261,"lon":262},33.61891,-117.92895,{"facility":264,"status":8,"city":265,"state":183,"zip":266,"country":95,"contacts":267,"geoPoint":274},"Valley Clinical Trials, LLC - Flourish Research","Northridge","91325",[268,272],{"name":269,"role":99,"phone":270,"email":271},"Monica Brown","818-280-4220","mbrown@flourishresearch.com",{"name":273,"role":104},"Mehrdad Ariani, MD",{"lat":275,"lon":276},34.22834,-118.53675,{"facility":278,"status":8,"city":279,"state":183,"zip":280,"country":95,"contacts":281,"geoPoint":288},"Riverside Community Hospital","Riverside","92501",[282,286],{"name":283,"role":99,"phone":284,"email":285},"Breanna Silesky","951-314-4907","breanne.silesky@hcahealthcare.com",{"name":287,"role":104},"Patrick Hu, MD",{"lat":289,"lon":290},33.95335,-117.39616,{"facility":292,"status":8,"city":293,"state":183,"zip":294,"country":95,"contacts":295,"geoPoint":302},"Kaiser Permanente - San Diego","San Diego","92123",[296,300],{"name":297,"role":99,"phone":298,"email":299},"Michael Fechter","1-858-266-6604","michael.d.fechter@kp.org",{"name":301,"role":104},"Bahram Khadivi, MD",{"lat":303,"lon":304},32.71571,-117.16472,{"facility":306,"status":8,"city":293,"state":183,"zip":294,"country":95,"contacts":307,"geoPoint":314},"San Diego Cardiac Center",[308,312],{"name":309,"role":99,"phone":310,"email":311},"Donna Small","858-244-6800","dsmall@sdcardiac.com",{"name":313,"role":104},"Jiken Bhatt, MD",{"lat":303,"lon":304},{"facility":316,"status":8,"city":317,"state":183,"zip":318,"country":95,"contacts":319,"geoPoint":326},"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","Torrance","90502",[320,324],{"name":321,"role":99,"phone":322,"email":323},"Olga Barillas","323-457-1933","olga@lundquist.org",{"name":325,"role":104},"Quang Bui, MD",{"lat":327,"lon":328},33.83585,-118.34063,{"facility":330,"status":8,"city":331,"state":183,"zip":332,"country":95,"contacts":333,"geoPoint":337},"The Heart Medical Group","Van Nuys","91406",[334,335],{"name":269,"role":99,"phone":270,"email":271},{"name":336,"role":104},"Munaf Shamji, MD",{"lat":338,"lon":339},34.18667,-118.44897,{"facility":341,"status":8,"city":342,"state":183,"zip":343,"country":95,"contacts":344,"geoPoint":352},"FOMAT - West Coast Research Center","Ventura","93030",[345,350],{"name":346,"role":99,"phone":347,"phoneExt":348,"email":349},"Thai Orantes","805-483-1185","839","torantes@fomatmedical.com",{"name":351,"role":104},"David Blitzer, MD",{"lat":353,"lon":354},34.27834,-119.29317,{"facility":356,"status":8,"city":357,"state":183,"zip":358,"country":95,"contacts":359,"geoPoint":366},"Interventional Cardiology Medical Group","West Hills","91307",[360,364],{"name":361,"role":99,"phone":362,"email":363},"Michael Fam","818-453-6111","mfam@elegantrd.com",{"name":365,"role":104},"Farhad Rafii, MD",{"lat":367,"lon":368},34.19731,-118.64398,{"facility":370,"status":8,"city":371,"state":372,"zip":373,"country":95,"contacts":374,"geoPoint":381},"University of Colorado Anschutz Medical Campus","Aurora","Colorado","80045",[375,379],{"name":376,"role":99,"phone":377,"email":378},"Dana Dubas","1-857-383-8096","dana.dubas@cuanschutz.edu",{"name":380,"role":104},"Connie Hess, MD",{"lat":382,"lon":383},39.72943,-104.83192,{"facility":385,"status":8,"city":386,"state":372,"zip":387,"country":95,"contacts":388,"geoPoint":395},"Aurora Denver Cardiology Associates - Englewood","Englewood","80113",[389,393],{"name":390,"role":99,"phone":391,"email":392},"Rylee Funkhouser","1-720-990-8071","rylee.funkhouser@hcahealthcare.com",{"name":394,"role":104},"Ehrin Armstrong, MD",{"lat":396,"lon":397},39.64777,-104.98776,{"facility":399,"status":8,"city":400,"state":372,"zip":401,"country":95,"contacts":402,"geoPoint":409},"ClinRe 001-001","Thornton","80023",[403,407],{"name":404,"role":99,"phone":405,"email":406},"Salman Gondal","1-720-772-8040","sgondal@clinre.com",{"name":408,"role":104},"Rajesh Sharma, MD",{"lat":410,"lon":411},39.86804,-104.97192,{"facility":413,"status":8,"city":414,"state":415,"zip":416,"country":95,"contacts":417,"geoPoint":424},"Bridgeport Hospital","Bridgeport","Connecticut","06610",[418,422],{"name":419,"role":99,"phone":420,"email":421},"Brenda Garcia","203-384-4205","brenda.garcia@bpthosp.org",{"name":423,"role":104},"Edward Tuohy, MD",{"lat":425,"lon":426},41.17923,-73.18945,{"facility":428,"status":8,"city":429,"state":415,"zip":430,"country":95,"contacts":431,"geoPoint":438},"Nuvance Health- Danbury Hospital","Danbury","06810",[432,436],{"name":433,"role":99,"phone":434,"email":435},"Danielle Souza","203-739-7600","danielle.souza@nuvancehealth.org",{"name":437,"role":104},"Hal Wasserman, MD",{"lat":439,"lon":440},41.39482,-73.45401,{"facility":442,"status":8,"city":443,"state":415,"zip":444,"country":95,"contacts":445,"geoPoint":456},"Cardiology Associates of Fairfield County","Stamford","06305",[446,450,454],{"name":447,"role":99,"phone":448,"email":449},"Lauren Rivera","203-246-9994","lrivera@cafconline.com",{"name":451,"role":99,"phone":452,"email":453},"Viktoria Klymenko","754-364-8485","vklymenko@cafconline.com",{"name":455,"role":104},"Edward Portnay, MD",{"lat":457,"lon":458},41.05343,-73.53873,{"facility":460,"status":8,"city":461,"state":462,"zip":463,"country":95,"contacts":464,"geoPoint":471},"BayCare Medical Group","Clearwater","Florida","33756",[465,469],{"name":466,"role":99,"phone":467,"email":468},"Delia Johnson","727-462-3578","delia.johnson@baycare.org",{"name":470,"role":104},"Rakesh Sharma, MD",{"lat":472,"lon":473},27.96585,-82.8001,{"facility":475,"status":8,"city":461,"state":462,"zip":463,"country":95,"contacts":476,"geoPoint":484},"Clearwater Cardiovascular Consultants",[477,482],{"name":478,"role":99,"phone":479,"phoneExt":480,"email":481},"Carolyn Rembish","727-467-9393","3117","rembishc@cccheart.com",{"name":483,"role":104},"Masood Gilani, MD",{"lat":472,"lon":473},{"facility":486,"status":8,"city":487,"state":462,"zip":488,"country":95,"contacts":489,"geoPoint":496},"Pioneer Clinical Studies","Coral Gables","33134",[490,494],{"name":491,"role":99,"phone":492,"email":493},"Jeff Somerstein","305-420-5541","jsomerstein@pioneerstudies.com",{"name":495,"role":104},"Vinod Chainani, MD",{"lat":497,"lon":498},25.72149,-80.26838,{"facility":500,"status":8,"city":501,"state":462,"zip":502,"country":95,"contacts":503,"geoPoint":510},"Arrow Clinical Trails","Daytona Beach","32117",[504,508],{"name":505,"role":99,"phone":506,"email":507},"Albert Garcia","386-278-8000","albert@arrowtrials.com",{"name":509,"role":104},"Charles Ross, MD",{"lat":511,"lon":512},29.21081,-81.02283,{"facility":514,"status":8,"city":515,"state":462,"zip":516,"country":95,"contacts":517,"geoPoint":524},"UF Health Jacksonville","Jacksonville","32209",[518,522],{"name":519,"role":99,"phone":520,"email":521},"Kailyn Herndon","1-904-244-8232","kailyn.herndon@ufhealth.org",{"name":523,"role":104},"Francesco Franchi, MD",{"lat":525,"lon":526},30.33218,-81.65565,{"facility":528,"status":8,"city":515,"state":462,"zip":529,"country":95,"contacts":530,"geoPoint":537},"First Coast Cardiovascular Institute, PA","32256",[531,535],{"name":532,"role":99,"phone":533,"email":534},"Alayna Socia","1-904-718-5787","asocia@firstcoastcardio.com",{"name":536,"role":104},"Yazan Khatib, MD",{"lat":525,"lon":526},{"facility":539,"status":8,"city":540,"state":462,"zip":541,"country":95,"contacts":542,"geoPoint":548},"Clearwater Cardiovascular and Interventional Consultants- Bardmoor","Largo","33777",[543,546],{"name":544,"role":99,"phone":479,"email":545},"Teresa Jones","jonest@cccheart.com",{"name":547,"role":104},"Alexander Heckman, MD",{"lat":549,"lon":550},27.90979,-82.78842,{"facility":552,"status":8,"city":553,"state":462,"zip":554,"country":95,"contacts":555,"geoPoint":562},"Inpatient Research Clinic, LLC","Miami Lakes","33014",[556,560],{"name":557,"role":99,"phone":558,"email":559},"Dora Gutierrez","786-502-4303","dgutierrez@inpatientresearch.com",{"name":561,"role":104},"Francisco Dieguez Jr, MD",{"lat":563,"lon":564},25.90871,-80.30866,{"facility":566,"status":8,"city":567,"state":462,"zip":568,"country":95,"contacts":569,"geoPoint":576},"Cardiovascular Institute of Northwest Florida","Panama City","32405",[570,574],{"name":571,"role":99,"phone":572,"email":573},"Shelley Sherk","505-918-7057","ssherk@cvinwfl.com",{"name":575,"role":104},"Amir Haghighat, 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Sinai","STUDY_CHAIR",{"name":1987,"affiliation":13,"role":1985},"Manesh Patel, MD",[1989,1993],{"pmid":1990,"type":1991,"citation":1992},"38972336","BACKGROUND","Navar AM, Shah NP, Shrader P, Thomas LE, Ahmad Z, Allred C, Chamberlain AM, Chrischilles EA, Dhalwani N, Effron MB, Hayek S, Jones LK, Kalich B, Shapiro MD, Wojcik C, Peterson ED. Achievement of LDL-C \u003C55 mg\u002FdL among US adults: Findings from the cvMOBIUS2 registry. Am Heart J. 2025 Jan;279:107-117. doi: 10.1016\u002Fj.ahj.2024.06.012. Epub 2024 Jul 6.",{"pmid":1994,"type":1991,"citation":1995},"31020929","Chamberlain AM, Gong Y, Shaw KM, Bian J, Song WL, Linton MF, Fonseca V, Price-Haywood E, Guhl E, King JB, Shah RU, Puro J, Shenkman E, Pawloski PA, Margolis KL, Hernandez AF, Cooper-DeHoff RM. PCSK9 Inhibitor Use in the Real World: Data From the National Patient-Centered Research Network. J Am Heart Assoc. 2019 May 7;8(9):e011246. doi: 10.1161\u002FJAHA.118.011246.",[],{"nct_id":4,"conditions":1998,"biomarkers":2000},[23,1999],"Peripheral Artery Disease",[],{"nct_id":4,"found":15,"summary":2002,"prompt_version":2012},{"design":2003,"status":2004,"heading":2005,"summary":2006,"follow_up":2007,"word_count":2008,"commitments":2009,"compensation":2010,"drugs_mentioned":2011},"This is a randomized, double-blind study where you would either receive inclisiran or a placebo (normal saline) injection. About 6000 participants will be enrolled.","completed","Inclisiran for Preventing Heart and Limb Problems After Procedures","This study is looking at whether inclisiran can help prevent serious heart problems (major adverse cardiovascular events or MACE) and serious leg\u002Ffoot problems (major adverse limb events or MALE) in people who have recently had a procedure to open blocked arteries in their heart (percutaneous coronary intervention or PCI) or legs (peripheral endovascular intervention or PVI). Inclisiran is a medication given as a shot under the skin every six months, after an initial dose and a follow-up dose at 3 months. It's already approved to lower cholesterol. You might be able to join if you are 18 or older and had a successful PCI or PVI within the last 14 days. The study aims to enroll about 6000 people and is currently recruiting.","You will be followed for up to approximately 4 years to track any major adverse cardiovascular or limb events.",123,"You would receive injections on Day 0, Day 90, and then every 6 months thereafter. The study will follow you for up to approximately 4 years.","Not stated in the trial record.",[],"v2"]