[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07517263":3,"trial-entities:NCT07517263":4565,"trial-summary:NCT07517263":4570},{"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":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":45,"secondary_outcomes":50,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":86,"locations":89,"central_contacts":4554,"overall_officials":4560,"references":4563,"see_also_links":4564},"NCT07517263","CTQJ230A12301E1","An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)","A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial","RECRUITING","2030-01-09","2026-07","2026-07-30","2026-05-11","Novartis Pharmaceuticals","INDUSTRY",false,"This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).","This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).",[19],"Cardiovascular Disease and Lipoprotein(a)",[21,22,23,24,25,26,27,28,29],"Lipoprotein(a),","Lp(a),","cardiovascular disease,","CVD,","myocardial infarction,","stroke,","OLE,","pelacarsen,","open-label","INTERVENTIONAL","TREATMENT",[33],"PHASE3",{"count":35,"type":36},5700,"ESTIMATED",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Pelacarsen (TQJ230)","pelacarsen 80mg s.c. monthly",[40],[44],"TQJ230",[46],{"measure":47,"description":48,"timeFrame":49},"Number of participants with Adverse events","Number of participants with Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of special interest, including abnormal laboratory evaluations and vital signs. Number of participants discontinuing due to treatment emergent adverse events (TEAEs) or treatment emergent serious adverse events (TESAEs) will also be presented.","Up to 36 months",[51,54,57,60,63,67,70],{"measure":52,"description":53,"timeFrame":49},"Time to first occurrence of 4 Point-Major Cardiovascular Event (4P-MACE) from parent study baseline","Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the parent study will be presented",{"measure":55,"description":56,"timeFrame":49},"Time to the first occurrence of 4P-MACE from open-label extension (OLE) study baseline","Time to first occurrence of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) from the beginning of the OLE study will be presented",{"measure":58,"description":59,"timeFrame":49},"Cumulative number of 4P-MACE over time from OLE study baseline","Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the OLE study will be presented",{"measure":61,"description":62,"timeFrame":49},"Cumulative number of 4P-MACE over time from parent study baseline","Cumulative number of 4P-MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or urgent coronary revascularization requiring hospitalization) over time from the beginning of the parent study will be presented",{"measure":64,"description":65,"timeFrame":66},"Observed value of Lipoprotein(a) (Lp(a))","Samples for Lp(a) assessment will be collected at the defined time points, analyzed and values reported.","Baseline, Month 3, Month 12, Month 24, Month 36",{"measure":68,"description":69,"timeFrame":66},"Change in Lp(a) compared to baseline of the OLE study","Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the OLE study.",{"measure":71,"description":72,"timeFrame":66},"Change in Lp(a) compared to baseline of the parent study","Samples for Lp(a) assessment will be collected at defined time points and change will be calculated against baseline of the parent study.","ALL","18 Years","100 Years",{"inclusion":77,"exclusion":80,"raw_text":85},[78,79],"Participants who have provided informed consent prior to initiation of any study-specific activities\u002Fprocedures.","Participants who have completed the parent study EOS visit while still on assigned investigational product.",[81,82,83,84],"Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.","Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.","Participants are receiving another investigational drug or device before the open-label treatment period.","Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.","Inclusion Criteria:\n\n* Participants who have provided informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n* Participants who have completed the parent study EOS visit while still on assigned investigational product.\n\nExclusion Criteria:\n\n* Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.\n* Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.\n* Participants are receiving another investigational drug or device before the open-label treatment period.\n* Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",[87,88],"ADULT","OLDER_ADULT",[90,108,122,136,151,165,179,194,209,220,228,242,256,270,283,290,304,317,331,341,354,368,383,398,412,426,441,455,469,483,497,510,524,538,553,564,578,593,607,622,630,645,659,674,681,690,704,718,732,746,760,774,787,794,809,824,834,847,860,874,888,892,900,911,925,938,952,966,980,988,995,999,1014,1028,1043,1057,1068,1076,1091,1106,1119,1134,1147,1158,1168,1182,1197,1211,1225,1239,1248,1263,1277,1291,1305,1318,1332,1346,1360,1374,1388,1403,1418,1432,1446,1460,1475,1486,1497,1511,1524,1538,1553,1567,1581,1595,1605,1619,1633,1648,1659,1670,1685,1700,1706,1709,1715,1718,1724,1727,1734,1741,1744,1751,1754,1760,1765,1767,1770,1776,1779,1785,1793,1799,1803,1809,1816,1823,1830,1836,1842,1848,1854,1857,1865,1872,1879,1886,1892,1898,1904,1910,1918,1925,1932,1939,1942,1948,1954,1961,1968,1974,1977,1984,1991,1998,2001,2007,2013,2016,2019,2021,2026,2029,2032,2035,2038,2044,2051,2057,2063,2069,2075,2081,2089,2092,2097,2100,2107,2113,2120,2126,2129,2132,2138,2141,2144,2152,2159,2166,2172,2179,2186,2189,2192,2199,2206,2209,2212,2218,2224,2231,2238,2244,2247,2254,2258,2265,2272,2279,2282,2288,2291,2294,2297,2303,2306,2309,2312,2318,2321,2324,2330,2338,2344,2351,2358,2361,2367,2370,2376,2384,2390,2396,2402,2406,2412,2418,2421,2427,2433,2436,2442,2448,2454,2460,2466,2472,2475,2481,2487,2493,2499,2501,2507,2513,2518,2521,2528,2534,2540,2546,2552,2558,2564,2571,2577,2583,2589,2595,2600,2606,2613,2619,2625,2631,2637,2643,2649,2655,2661,2669,2673,2679,2682,2689,2692,2699,2706,2709,2715,2721,2725,2732,2738,2741,2747,2754,2761,2767,2773,2779,2785,2791,2797,2800,2803,2806,2809,2812,2818,2824,2830,2833,2836,2838,2841,2843,2846,2852,2858,2861,2867,2873,2879,2882,2888,2894,2900,2906,2912,2918,2924,2931,2934,2937,2943,2949,2955,2961,2963,2970,2976,2982,2985,2988,2994,3001,3009,3016,3019,3025,3032,3038,3044,3051,3054,3057,3064,3067,3070,3073,3079,3085,3088,3091,3098,3101,3108,3115,3121,3124,3131,3134,3140,3147,3153,3160,3166,3169,3176,3182,3185,3191,3197,3203,3209,3217,3224,3231,3238,3245,3252,3259,3266,3269,3272,3275,3281,3288,3295,3302,3305,3312,3315,3322,3329,3334,3342,3348,3355,3362,3368,3374,3381,3388,3395,3402,3409,3416,3423,3429,3435,3442,3446,3452,3459,3466,3470,3473,3476,3482,3485,3491,3497,3505,3511,3517,3523,3530,3537,3543,3546,3552,3559,3565,3572,3579,3586,3591,3597,3603,3609,3615,3621,3627,3633,3640,3646,3653,3659,3665,3671,3677,3680,3686,3693,3699,3705,3720,3727,3734,3741,3744,3750,3753,3760,3766,3772,3778,3784,3790,3796,3802,3805,3808,3811,3814,3820,3826,3832,3838,3841,3844,3847,3850,3853,3856,3862,3868,3871,3874,3880,3886,3892,3898,3904,3907,3910,3917,3923,3929,3932,3935,3938,3944,3950,3953,3959,3965,3971,3974,3977,3983,3989,3995,4001,4003,4009,4015,4022,4024,4032,4038,4041,4049,4056,4060,4066,4073,4079,4082,4088,4094,4097,4100,4105,4111,4118,4124,4131,4138,4145,4151,4156,4159,4164,4170,4176,4179,4185,4188,4191,4197,4204,4210,4216,4223,4229,4234,4240,4246,4252,4260,4266,4272,4275,4281,4287,4293,4299,4305,4313,4320,4327,4331,4338,4344,4351,4354,4362,4369,4373,4380,4387,4394,4401,4408,4415,4422,4428,4435,4442,4448,4454,4457,4463,4469,4475,4481,4484,4490,4496,4502,4507,4513,4519,4525,4531,4537,4543,4545,4548],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":105},"SEC Clinical Research LLC","Andalusia","Alabama","36420","United States",[97,102],{"name":98,"role":99,"phone":100,"email":101},"Lauren Williams","CONTACT","+1 334 699 1631","lwilliams@secclinicalresearch.com",{"name":103,"role":104},"Andreas Muench","PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},31.30808,-86.48243,{"facility":109,"status":8,"city":110,"state":93,"zip":111,"country":95,"contacts":112,"geoPoint":119},"Heart Center Research Llc","Huntsville","35801",[113,117],{"name":114,"role":99,"phone":115,"email":116},"Melesa Lamb","+1 256 519 8255","mlamb@theheartcenter.md",{"name":118,"role":104},"Vernon R Hunter",{"lat":120,"lon":121},34.7304,-86.58594,{"facility":123,"status":8,"city":124,"state":93,"zip":125,"country":95,"contacts":126,"geoPoint":133},"Mobile Heart Specialists","Mobile","36608",[127,131],{"name":128,"role":99,"phone":129,"email":130},"Candace Jenkins","+1 251 433 4700","cjenkins@mobheart.com",{"name":132,"role":104},"Christopher S Brown",{"lat":134,"lon":135},30.69436,-88.04305,{"facility":137,"status":8,"city":138,"state":139,"zip":140,"country":95,"contacts":141,"geoPoint":148},"Mercy Gilbert Medical Center","Gilbert","Arizona","85297",[142,146],{"name":143,"role":99,"phone":144,"email":145},"Chanel Tate","+1 480 728 9978","chanel.tate@commonspirit.org",{"name":147,"role":104},"Nabil Dib",{"lat":149,"lon":150},33.35283,-111.78903,{"facility":152,"status":8,"city":153,"state":139,"zip":154,"country":95,"contacts":155,"geoPoint":162},"Clinical Research Inst of Arizona","Sun City West","85375",[156,160],{"name":157,"role":99,"phone":158,"email":159},"Georgina Lopez-Wood","+1 623 223 1580","glopezwood@criofaz.com",{"name":161,"role":104},"Jalal Abbas",{"lat":163,"lon":164},33.66198,-112.34127,{"facility":166,"status":8,"city":167,"state":139,"zip":168,"country":95,"contacts":169,"geoPoint":176},"Eclipse Clinical Research","Tucson","85745",[170,174],{"name":171,"role":99,"phone":172,"email":173},"Felice J Anderson","+1 520 647 9926","felice@eclipsecr.com",{"name":175,"role":104},"Eve Shapiro",{"lat":177,"lon":178},32.22174,-110.92648,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":95,"contacts":184,"geoPoint":191},"Cardiology and Medicine Clinic PA","Little Rock","Arkansas","72204",[185,189],{"name":186,"role":99,"phone":187,"email":188},"Sherry Clements","+1 501 664 0941","sclementsresearch@yahoo.com",{"name":190,"role":104},"Joe L Hargrove",{"lat":192,"lon":193},34.74648,-92.28959,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":95,"contacts":199,"geoPoint":206},"Cardiovascular Res Found","Beverly Hills","California","90210",[200,204],{"name":201,"role":99,"phone":202,"email":203},"Monalisa Nzenwa","+1 310 278 3400","MonaLisa.Nzenwa@cvmg.com",{"name":205,"role":104},"Ronald P Karlsberg",{"lat":207,"lon":208},34.07362,-118.40036,{"facility":210,"status":8,"city":196,"state":197,"zip":211,"country":95,"contacts":212,"geoPoint":219},"National Heart Institute","90211",[213,217],{"name":214,"role":99,"phone":215,"email":216},"Nayeli Aguillon","+1 301 289 5221","naguillon@nationalheartinstitute.org",{"name":218,"role":104},"Norman Lepor",{"lat":207,"lon":208},{"facility":221,"status":222,"city":223,"state":197,"zip":224,"country":95,"geoPoint":225},"Valley Clinical Trials Inc","ACTIVE_NOT_RECRUITING","Covina","91723",{"lat":226,"lon":227},34.09001,-117.89034,{"facility":229,"status":8,"city":230,"state":197,"zip":231,"country":95,"contacts":232,"geoPoint":239},"Diabetes Lipid Management Center","Huntington Beach","92648",[233,237],{"name":234,"role":99,"phone":235,"email":236},"Denden Yehdego","+1 714 375 7386","dendenyehdego@researchca.com",{"name":238,"role":104},"Paul D. Rosenblit",{"lat":240,"lon":241},33.6603,-117.99923,{"facility":243,"status":8,"city":244,"state":197,"zip":245,"country":95,"contacts":246,"geoPoint":253},"University of Calif Irvine Med Cntr","Irvine","92660",[247,251],{"name":248,"role":99,"phone":249,"email":250},"Maryam Ahmed","+1 714 456 8653","maryasa1@hs.uci.edu",{"name":252,"role":104},"Ailin Barseghian El-Farra",{"lat":254,"lon":255},33.66946,-117.82311,{"facility":257,"status":8,"city":258,"state":197,"zip":259,"country":95,"contacts":260,"geoPoint":267},"Memorial Care Health System","Long Beach","90806",[261,265],{"name":262,"role":99,"phone":263,"email":264},"Karina Vargas Gonzalez","+1 562 933 2000","kvargasgonzalez@memorialcare.org",{"name":266,"role":104},"Ron Sklash",{"lat":268,"lon":269},33.76696,-118.18923,{"facility":271,"status":8,"city":272,"state":197,"zip":273,"country":95,"contacts":274,"geoPoint":280},"Keck Medical Center USC","Los Angeles","90033",[275,278],{"name":276,"role":99,"email":277},"Jasbeth Almanza","jasbeth.almanza@med.usc.edu",{"name":279,"role":104},"Parveen Garg",{"lat":281,"lon":282},34.05223,-118.24368,{"facility":284,"status":222,"city":285,"state":197,"zip":286,"country":95,"geoPoint":287},"Valley Clinical Trials","Northridge","91325",{"lat":288,"lon":289},34.22834,-118.53675,{"facility":291,"status":8,"city":292,"state":197,"zip":293,"country":95,"contacts":294,"geoPoint":301},"Stanford University Medical Center","Palo Alto","94304",[295,299],{"name":296,"role":99,"phone":297,"email":298},"Tamara Bazouzi","+1 650 721 1020","bazouzit@stanford.edu",{"name":300,"role":104},"Abha Khandelwal",{"lat":302,"lon":303},37.44188,-122.14302,{"facility":305,"status":8,"city":306,"state":197,"zip":307,"country":95,"contacts":308,"geoPoint":314},"University of California San Diego","San Diego","92103",[309,312],{"name":310,"role":99,"email":311},"Gavin McLaren","gmclaren@health.ucsd.edu",{"name":313,"role":104},"Michael John Wilkinson",{"lat":315,"lon":316},32.71571,-117.16472,{"facility":318,"status":8,"city":319,"state":197,"zip":320,"country":95,"contacts":321,"geoPoint":328},"UCSF","San Francisco","94115",[322,326],{"name":323,"role":99,"phone":324,"email":325},"Liliann Zou","+1 415 514 0992","liliann.zou@ucsf.edu",{"name":327,"role":104},"Eveline O Stock",{"lat":329,"lon":330},37.77493,-122.41942,{"facility":332,"status":8,"city":333,"state":197,"zip":334,"country":95,"contacts":335,"geoPoint":338},"Helping Hands Medical Associates INC","Santa Ana","92704",[336],{"role":99,"phone":337},"+1 714 662 2900",{"lat":339,"lon":340},33.74557,-117.86783,{"facility":342,"status":8,"city":343,"state":197,"zip":344,"country":95,"contacts":345,"geoPoint":351},"Manshadi Heart Institute","Stockton","95204",[346,349],{"name":347,"role":99,"email":348},"Delaina Sanguinetti","d.sanguinetti@drmanshadi.com",{"name":350,"role":104},"Ramin Manshadi",{"lat":352,"lon":353},37.9577,-121.29078,{"facility":355,"status":8,"city":356,"state":197,"zip":357,"country":95,"contacts":358,"geoPoint":365},"Interv Cardiology Med Grp","West Hills","91307",[359,363],{"name":360,"role":99,"phone":361,"email":362},"Michael Fam","+1 818 235 7104","mfam@elegantrd.com",{"name":364,"role":104},"Farhad Rafii",{"lat":366,"lon":367},34.19731,-118.64398,{"facility":369,"status":8,"city":370,"state":371,"zip":372,"country":95,"contacts":373,"geoPoint":380},"Univ Of Color Anschutz Med Center","Aurora","Colorado","80045",[374,378],{"name":375,"role":99,"phone":376,"email":377},"Reenadevi Agarwal","+1 303 724 0890","reenadevi.agarwal@cuanschutz.edu",{"name":379,"role":104},"David Saxon",{"lat":381,"lon":382},39.72943,-104.83192,{"facility":384,"status":8,"city":385,"state":386,"zip":387,"country":95,"contacts":388,"geoPoint":395},"Bridgeport Hospital","Bridgeport","Connecticut","06610",[389,393],{"name":390,"role":99,"phone":391,"email":392},"Tina Mccurry","+1 203 384 4849","Tina.McCurry@bpthosp.org",{"name":394,"role":104},"Adam Schussheim",{"lat":396,"lon":397},41.17923,-73.18945,{"facility":399,"status":8,"city":400,"state":386,"zip":401,"country":95,"contacts":402,"geoPoint":409},"Hartford Hospital","Hartford","06102",[403,407],{"name":404,"role":99,"phone":405,"email":406},"Keelyn Kotecki","+1 860 545 2882","keelyn.kotecki@hhchealth.org",{"name":408,"role":104},"Antonio Fernandez",{"lat":410,"lon":411},41.76371,-72.68509,{"facility":413,"status":8,"city":414,"state":386,"zip":415,"country":95,"contacts":416,"geoPoint":423},"Chase Medical Research LLC","Waterbury","06708",[417,421],{"name":418,"role":99,"phone":419,"email":420},"La Tonya Washington","+1 203 232 3749","lwashington@chasemr.com",{"name":422,"role":104},"Ashish Adlakha",{"lat":424,"lon":425},41.55815,-73.0515,{"facility":427,"status":8,"city":428,"state":429,"zip":430,"country":95,"contacts":431,"geoPoint":438},"Excel Medical Clinical Trials LLC","Boca Raton","Florida","33434",[432,436],{"name":433,"role":99,"phone":434,"email":435},"Joseph Ramsey","+1 561 756 8206","jramsey@flourishresearch.com",{"name":437,"role":104},"Rasha Youssef",{"lat":439,"lon":440},26.35869,-80.0831,{"facility":442,"status":8,"city":443,"state":429,"zip":444,"country":95,"contacts":445,"geoPoint":452},"Bay Area Cardiology Assoc","Brandon","33511",[446,450],{"name":447,"role":99,"phone":448,"email":449},"Leonor Guerra","+1 813 684 6000","lguerra@bayareacardiology.com",{"name":451,"role":104},"Ranchhod Khant",{"lat":453,"lon":454},27.9378,-82.28592,{"facility":456,"status":8,"city":457,"state":429,"zip":458,"country":95,"contacts":459,"geoPoint":466},"Jacksonville Center for Clinical Research","Jacksonville","32216",[460,464],{"name":461,"role":99,"phone":462,"email":463},"Theresa Hanburry","+1 904 730 0101","thanburry@encoredocs.com",{"name":465,"role":104},"Michael J 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