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Rosuvastatin plus Ezetimibe plus bempedoic acid versus statin

Comparison of triple therapy (moderate intensity ROSuvastatin plus Ezetimibe plus bempeDoic acid) verus moderate to high intensity statin (ROSuvastatin) in patients with acute coronary syndrome. A first in world randomized ,single centre trial - Nil

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/081447
Enrollment
118
Registered
2025-02-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: I999- Unspecified disorder of circulatory system

Interventions

Intervention1: Rosuvastatin plus Ezetimibe plus BEmpedoic acid: moderate intensity rosuvastatin 20mg + bempedoic acid 180mg + ezetimibe 10 mg ( all once a day ) per oral x 42 days Control Intervention

Sponsors

Sun Pharmaceuticals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age greater than 18 to 85 with acute coronary syndrome with LDL done within first 24 hour of ACS more than 100 mg%

Exclusion criteria

Exclusion criteria: Patients with cardiogenic shock, end stage CKD, CLD, allergy to statins/ bempedoic acid or ezetimibe, hyperuricemia and those who will not provide informed consent

Design outcomes

Primary

MeasureTime frame
Mean LDL at 6 weeks post initiation of therapyTimepoint: 6 weeks post initiation of therapy

Secondary

MeasureTime frame
% achieved target based on LAI, Mean TG reduction, mean non-HDL reduction, mean apo B-100 reduction, mean hs-CRP reduction, mean CPK level at 6 weeks, death or MI or repeat revascularization or stroke (MACE), and drug discontinuation rate Timepoint: 6 WEEKS

Countries

India

Contacts

Public ContactDr Nagendra Boopathy S

Sri Ramachandra Institute of Higher Education

drsnboopathy@gmail.com04445928916

Outcome results

None listed

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