Comparing two cholesterol lowering medicine combinations using internal heart scans to shrink and stabilise artery plaque in recent heart attack patients.

An exploratory comparative Intravascular imaging study(IVUS) to evaluate the impact of high intensity statin plus bempedoic acid combination therapy versus high statin plus ezetimibe combination therapy on plaque remodelling and stabilisation in patients with recent acute myocardial infarction(both STEMI and NSTEMI). - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112504

Enrollment

150

Registered

2026-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention1: STATIN plus BEMPEDOIC ACID: STATIN(MAXIMUM TOLERATED DOSE) ORAL plus BEMPEDOIC ACID 180 mg HS ORAL for 12 months Control Intervention1: STATIN plus EZETIMIBE: STATIN(MAXIMUM TOLERATED

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age more than equal to 18 years. 2)Recent ST Elevation or Non ST Elevation myocardial infarction within past 2 to 4 weeks. 3)Undergoing clinically indicated coronary angiography/Percutaneous Coronary Intervention. 4)At least one non-culprit coronary artery with angiographic stenosis of 20-50% suitable for IVUS/OCT imaging 5)On high-intensity statin therapy. 6)LDL more than equal to 70mg/dl despite statin therapy. 7)Willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1)Contraindicated or intolerance to Statins or bempedoic acid 2)Severe renal dysfunction(eGFR less than 30ml/min/1.73 m2) 3)Active liver disease or ALT/AST more than 3 times the upper limit of normal. 4)Cardiogenic shock or hemodynamic instability 5)Life expectancy less than one year. 6)Pregnancy or breast feeding. 7)Previously on statin therapy.

Design outcomes

Primary

Measure	Time frame
To evaluate change in coronary plaque burden as measured by Percent atheroma volume and total atheroma volume using Intra vascular ultrasound(IVUS) after 12 months of treatment with high intensity statin(maximum tolerated dose) and bempedoic acid combination therapy versus high intensity statin(maximum tolerated dose) plus ezetimibe combination therapy following acute myocardial infarction (both STEMI and NSTEMI).Timepoint: To evaluate change in coronary plaque burden as measured by Percent atheroma volume and total atheroma volume using Intra vascular ultrasound(IVUS) after 12 months of treatment with high intensity statin(maximum tolerated dose) and bempedoic acid combination therapy versus high intensity statin(maximum tolerated dose) plus ezetimibe combination therapy following acute myocardial infarction (both STEMI and NSTEMI).	—

Measure

Time frame

To evaluate change in coronary plaque burden as measured by Percent atheroma volume and total atheroma volume using Intra vascular ultrasound(IVUS) after 12 months of treatment with high intensity statin(maximum tolerated dose) and bempedoic acid combination therapy versus high intensity statin(maximum tolerated dose) plus ezetimibe combination therapy following acute myocardial infarction (both STEMI and NSTEMI).Timepoint: To evaluate change in coronary plaque burden as measured by Percent atheroma volume and total atheroma volume using Intra vascular ultrasound(IVUS) after 12 months of treatment with high intensity statin(maximum tolerated dose) and bempedoic acid combination therapy versus high intensity statin(maximum tolerated dose) plus ezetimibe combination therapy following acute myocardial infarction (both STEMI and NSTEMI).

—

Secondary

Measure	Time frame
To evaluate the effect of the intervention through A) intravascular ultrasound- 1)change in minimum lumen area 2)lumen diameter 3)Remodelling index B)changes in lipid parameters- 1)LDL 2)Non HDL-C 3)Apo A1 4)Lp(a) 5)Apo-B 6)HS-CRP C)To assess safety and tolerability of high dose statin plus bempedoic acid and high dose statin plus ezetimibe therapy in post MI patients. Timepoint: 12 months	—

Countries

India

Contacts

Public ContactDr Bhushan Shah

AIIMS BHOPAL

bhushanshah007@gmail.com9168102211

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026