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STUDY COMPARING ORAL LIPID-LOWERING STRATEGIES IN PCI-TREATED, STATIN NAIVE PATIENTS

A RANDOMIZED CONTROLLED STUDY COMPARING ORAL LIPID-LOWERING STRATEGIES IN PCI-TREATED, STATIN NAIVE PATIENTS WITH ACUTE CORONARY SYNDROME - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108796
Enrollment
300
Registered
2026-04-20
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: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: Rosuvastatin: Dose 40 mg Once - at night time Route - Oral Duration - 6 weeks Control Intervention1: Ezetimibe 10 mg, Rosuvastatin 40 mg: EZ 10 MG, STATIN 40 MG Once - at night time R

Sponsors

Department of Cardiology Mahatma Gandhi Medical College & Hospital Sitapura, Jaipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 All consecutive adult patients above 18 years upto 75 years of age 2 Baseline LDL C levels at the time of Admission more than 115 mg dL 3 Presenting with a diagnosis of ACS as NSTEMI or STEMI between April 2026 and September 2027 who will undergo PCI will be considered for enrolment 4 Undergone successful PCI for ACS will be required to be able and willing to provide written informed consent 5 Patients diagnosed with myocardial infarction both ST segment Elevation and non ST segment elevation treated with percutaneous coronary intervention myocardial infarction is defined as in the 4th Universal Definition of Myocardial Infarction 6 Patients have to be statin-na ve they need to agree to periodic outpatient follow-up visits and blood sampling for scheduled lipid analysis at 6 weeks meaning they had not received any statin or non-statin lipid-lowering therapy in the preceding six months

Exclusion criteria

Exclusion criteria: 1 Patients with a life expectancy of a year or less due to malignancy 2 Patients with chronic liver disease 3 Patients with sensitivity to the active ingredient of the drugs for the trial ezetimibe, atorvastatin and or bempedoic acid or patients who are prohibited from taking ezetimibe atorvastatin and or bempedoic acid. 4 Pregnant and or breastfeeding. 5 Patients receiving haemodialysis peritoneal dialysis patients and or kidney transplant patients due to end-stage renal disease 6 Patients were considered unfit for the study for any other reasons by the inspectors 7 Patients with prior statin or other lipid lowering drug use within six months 8 Contraindications to statin or Ezetimibe therapy severe hepatic hepatic enzymes aspartate-alanine transaminases 3 times upper limit or renal dysfunction eGFR 30 ml min 1.73 m2 need for staged PCI hemodynamic instability or anticipated inability to comply with the follow up protocol

Design outcomes

Primary

MeasureTime frame
To study the percentage change in LDL-C at 6 weeks Comparison of various Lipid Lowering Therapies of similar capacity : Combination vs Monotherapy To determine the no. of patients achieving the levels of LDL-C below 50 mg/dL and 70 mg/dL at 6 weeks Timepoint: 6 weeks

Secondary

MeasureTime frame
Statins-associated muscle symptoms Correlation of comorbidities with Levels of LDL-C reduction during the study Find out the Treatment discontinuation rates Timepoint: 6 weeks

Countries

India

Contacts

Public ContactDr Jatin Garg

Mahatma Gandhi Medical College Hospital

jatingarg2868@gmail.com9888988902

Outcome results

None listed

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