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A study to compare the effect of Bempedoic acid added to statin therapy vs statin monotherapy in lowering the remnant cholesterol

A study to compare the effect of Bempedoic acid added to statin therapy vs statin monotherapy in lowering the remnant cholesterol in established Atherosclerotic cardiovascular disease(ASCVD) patients: A randomized controlled trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082077
Enrollment
88
Registered
2025-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: I252- Old myocardial infarction Health Condition 3: I258- Other forms of chronic ischemic heart disease Health Condition 4: I509- Heart failure, unspecified Health Condition 5: I639- Cerebral infarction, unspecified Health Condition 6: I709- Other and unspecified atherosclerosis

Interventions

Intervention1: Bempedoic acid with Maximum Tolerated dose of statins: Bempedoic acid 180 milligrams once daily, oral route for 90 days. Statins- maximum tolerated dose, once daily, oral route for 90

Sponsors

Dr Ashwin J Dhas K S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with established ASCVD on statins 2)LDL cholesterol of more than 55 mg/dl

Exclusion criteria

Exclusion criteria: 1)Patients without established ASCVD 2)Patients not on statins 3)Lactating breastfeeding mothers 4)LDL cholesterol of less than 55 mg/dl 5)patients already on bempedoic acid 6)Patients on other anti-lipidemic drugs other than statins

Design outcomes

Primary

MeasureTime frame
To establish the effect of bempedoic acid in lowering the remnant cholesterolTimepoint: DAY 0 AND DAY 90—

Secondary

MeasureTime frame
To determine the effect of bempedoic acid on other components of lipid profile,Apolipoprotein B and HsCRPTimepoint: DAY 0 AND DAY 90—

Countries

India

Contacts

Public ContactDr Ashwin J Dhas K S

SRM Medical College Hospital And Research Center

kumarj1@srmist.edu.in9840047678

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026