Comparison of Adding Bempedoic Acid and Ezetimibe Versus Increasing Atorvastatin Dose in Patients with Heart Disease Who Have High LDL Cholesterol Despite Treatment

Efficacy and Safety of Add-On Bempedoic Acid Ezetimibe Versus Atorvastatin Dose Escalation in Coronary Artery Disease Patients with Uncontrolled LDL-Cholesterol on Atorvastatin 40 mg: A Double-Blind Parallel-Group Randomised Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082202

Enrollment

220

Registered

2025-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified

Interventions

Intervention1: Tablet of bempedoic acid 180 mg and ezetimibe 10 mg fixed dose combination: Tablet of bempedoic acid 180 mg and ezetimibe 10 mg fixed dose combination and placebo tablet of atorvastatin

Eligibility

Inclusion criteria

Inclusion criteria: Documented coronary artery disease confirmed by angiography or a prior history of myocardial infarction patients On a stable dose of atorvastatin 40 mg for at least 6 weeks before screening LDL-C more than 55 mg/dL at screening, despite being on atorvastatin 40 mg Written informed consent

Exclusion criteria

Exclusion criteria: Women who are pregnant, breastfeeding, or planning to become pregnant during the study period severe diabetes and complications (e.g., diabetic ketoacidosis, hyperosmolar nonketotic coma). recent history of major cardiovascular events, transient ischemic attack, unstable or symptomatic cardiac arrhythmia, or history of severe heart failure, uncontrolled hypertension history of gout or elevated uric acid levels fasting blood triglycerides greater than 500 mg/dL at screening significant liver disease, active hepatitis, severe hepatic impairment, or liver failure history of rhabdomyolysis, unexplained muscle pain, weakness, or unexplained creatinine kinase history of tendon rupture recently severe renal impairment use of other lipid-lowering therapies

Design outcomes

Primary

Measure	Time frame
Change in LDL-C levels from baseline to 8 weeks in both treatment groupsTimepoint: 0,4,8 weeks	—

Secondary

Measure	Time frame
Change in total cholesterol, non-HDL-C, triglycerides & lipoprotein (a) from baseline to 8 weeksTimepoint: 0,4,8 weeks ;Safety & tolerability outcomes, including: Incidence of adverse events. Discontinuation due to adverse events. Laboratory abnormalities (e.g., liver enzymes, renal function, creatine phosphokinase levels for muscle toxicity, complete blood count, HbA1C, Thyroid profile). Any serious adverse events. Timepoint: 4, 8 weeks;percentage of patients achieving LDL-C less than 55 mg/dL at 8 weeksTimepoint: 0,8 weeks	—

Measure

Time frame

Change in total cholesterol, non-HDL-C, triglycerides & lipoprotein (a) from baseline to 8 weeksTimepoint: 0,4,8 weeks ;Safety & tolerability outcomes, including: Incidence of adverse events. Discontinuation due to adverse events. Laboratory abnormalities (e.g., liver enzymes, renal function, creatine phosphokinase levels for muscle toxicity, complete blood count, HbA1C, Thyroid profile). Any serious adverse events. Timepoint: 4, 8 weeks;percentage of patients achieving LDL-C less than 55 mg/dL at 8 weeksTimepoint: 0,8 weeks

—

Countries

India

Contacts

Public ContactAmalkrishnan

All India Institute of Medical Sciences New Delhi

dsarya16@gmail.com9810210834

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026