{"id":"nct:NCT05739383","kind":"trial","title":"A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.","authors":["Novartis Pharmaceuticals"],"author_count":1,"year":2023,"published":"2023-02-22","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT05739383","source_url":"https://clinicaltrials.gov/study/NCT05739383","archive_url":"https://space-kitty.com/papers/nct:NCT05739383","updated":"2026-09-04","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Primary Prevention of Atherosclerotic Cardiovascular Disease"],"details":{"acronym":null,"status":"ACTIVE_NOT_RECRUITING","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":14012,"sponsor":"Novartis Pharmaceuticals","conditions":["Primary Prevention of Atherosclerotic Cardiovascular Disease"],"interventions":["DRUG: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL","DRUG: Placebo in 1.5ml"],"start_date":"2023-03-09","start_date_type":"ACTUAL","primary_completion_date":"2029-04-16","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"cardiovascular-innovation","name":"Cardiovascular Therapeutics","domain_slug":"medicine"}],"cited_in_dossiers":[]}