[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611348":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":27,"responsibleParty":42,"collaborators":27,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":27,"enrollmentInfo":55,"targetDuration":27,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":27,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":27},{"fullName":5,"class":6},"Sheikh Zayed Federal Postgraduate Medical Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (Bempedoic acid)","ACTIVE_COMPARATOR","BA 180 mg once daily + placebo statin.",[13,14],"Drug: Bempedoic Acid 180 MG Oral Tablet","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm B (Statin)","PLACEBO_COMPARATOR","Rosuvastatin 5 mg once daily + placebo BA.",[20,14],"Drug: Rosuvastatin 5 mg",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Bempedoic Acid 180 MG Oral Tablet","BA 180mg OD",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Rosuvastatin 5 mg","rosuvastatin 5mg HS",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Placebo","Placebo given OD",[9,16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Sohaib Ashraf Consultant Cardiologist, MD Cardiology","CONTACT","+923334474523","sohaib-ashraf@outlook.com",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Sohaib Ashraf","Consultant Cardiologist","100611348","phase-3-bempedoic-acid-versus-statins-in-primary-prevention-patients-with-suboptimal-statin-adherence-effects-on-ldl-c-reduction-and-tolerability-100611348",false,"NCT07239414","Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability","BASIS","Inclusion Criteria\n\n* Adults aged ≥40 years with no established ASCVD (no prior myocardial infarction, stroke, or acute coronary syndrome).\n* Indicated for lipid-lowering therapy (LDL-C ≥130 mg\u002FdL or 10-year ASCVD risk\n\n  ≥7.5%).\n* Documented history of poor statin adherence, defined as:\n\n  * Self-reported adherence \\\u003C80% in the past 3 months, or\n  * Prior statin discontinuation for adverse effects documented in the medical record.\n* Willingness to provide written informed consent. Exclusion Criteria\n* Established ASCVD (secondary prevention).\n* Severe hepatic impairment (ALT or AST \\>3× upper limit of normal).\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n* Pregnancy, breastfeeding, or women of childbearing potential not using contraception.\n* Current or planned treatment with PCSK9 inhibitors, fibrates, or niacin.\n* Known hypersensitivity to study drugs or excipients.","ALL","40 Years",{"count":56,"type":57},690,"ESTIMATED","INTERVENTIONAL",[60],"PHASE3","Bempedoic acid is an oral, non-statin LDL-cholesterol (LDL-C) lowering agent that inhibits ATP citrate lyase (ACL), upstream of HMG-CoA reductase (the enzyme inhibited by statins).\n\nMDPI\n\n+1\n\nIn patients with hypercholesterolemia who are unable to tolerate statins, or have sub-optimal statin adherence\u002Ftolerance, bempedoic acid has been shown to reduce LDL-C by \\~20-30% (monotherapy) and more when added to other therapies (e.g., ezetimibe) (≈30-40%).\n\nPubMed\n\n* 2 medicinejournal.in\n* 2\n\nIn the large primary-prevention subgroup of the trial CLEAR Outcomes (statin-intolerant patients without prior cardiovascular event), bempedoic acid (180 mg daily) lowered LDL-C by \\~21.3% and hs-CRP by \\~21.5%. It also was associated with a significant reduction in major adverse cardiovascular events (MACE): hazard ratio 0.70 (95% CI 0.55-0.89) versus placebo over \\~40 months.\n\nPubMed +1\n\nRegarding tolerability: muscle-related adverse events appear lower compared to statins (because bempedoic acid is activated only in the liver, not in skeletal muscle) and it appears generally well tolerated, but there are signals of increased uric acid\u002Fgout, elevated hepatic enzymes, and creatinine\u002Frenal effects.\n\nMDPI\n\n+1\n\nComparative cardiovascular benefit (when normalized per unit LDL-C reduction) suggests that bempedoic acid may yield similar relative risk reductions as statins, though absolute LDL-C lowering is less.",[63],"Cardiovascular",[65],"bempodoic acid","NOT_YET_RECRUITING","2025-11-16",{"date":69,"type":70},"2025-11-20","ACTUAL",{"date":72,"type":57},"2025-11-10",{"date":74,"type":57},"2027-02-21",{"name":44,"class":6}]