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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

NCT03169985.

Trial name or title Usual dose Rosuvastatin plus EZetimibe versus high‐dose rosuvastatin on coronary atherosclerotic plaque (Rosuzet‐IVUS)
Methods Prospective, open‐label, two‐arm, randomised controlled trial
Participants Estimated Enrollment: 280
Inclusion Criteria:

  1. among patients who undergo coronary angiography (CAG) for suspected ischaemic heart disease and meet all of the followings: moderate stenosis (30% to 70%) in coronary artery, deferred to medical treatment based on physiologic or radiologic evaluation;

  2. agreement obtained by participant.


Exclusion Criteria:

  1. severe renal failure (glomerular filtration rate < 30 mL/min/1.73 m2, haemodialysis or peritoneal dialysis);

  2. active liver disease;

  3. patient taking Niacin or fibrate (if possible, patient can be enrolled to the study after stopping those medication);

  4. medical or family history of myositis, unexplained creatine kinase (CK) elevation > 3 times ULN at first visit;

  5. life expectancy < 2 years (judged by investigator);

  6. co‐administration of cyclosporine;

  7. untreated hypothyroidism;

  8. patient with poor compliance including alcohol abuse;

  9. history of hypersensitivity including myotoxicity for either statin or ezetimibe;

  10. pregnant or breast‐feeding woman;

  11. other conditions inappropriate for enrolment by investigator: eligible patients will be randomly assigned to treatment arms, stratified by diagnosis on admission(acute coronary syndrome or stable ischaemic heart disease) and presence of chronic statin use (more than one month).
Interventions Rosuvastatin 10 mg/day plus ezetimibe 10 mg/day versus rosuvastatin 20 mg/day
Outcomes Primary:

  1. change in per cent atheroma volume (PAV) in non‐culprit lesions (Time Frame: 12 months after index CAG).


Secondary:

  1. change in normalised total atheroma volume (TAV) in non‐culprit lesions (Time Frame: 12 months after index CAG);

  2. change in indexed TAV (Time Frame: 12 months after index CAG);

  3. change in fibrous cap thickness by OCT(optical coherence tomography) (Time Frame: 12 months after index CAG);

  4. change in fractional flow reserve (FFR) (Time Frame: 12 months after index CAG;)

  5. change in coronary flow reserve (CFR) (Time Frame: 12 months after index CAG);

  6. change in index of microcirculatory resistance (IMR) (Time Frame: 12 months after index CAG);

  7. change in TAV in coronary computed tomography(CT) angiography (Time Frame: 24 months after index CAG);

  8. major adverse cardiovascular events (MACE) (Time Frame: 12, 24 and 36 months after index CAG, MACE is defined as a composite of death, MI, stroke and revascularisation;

  9. change in homeostatic model assessment (HOMA) index (Time Frame: 6 months after index CAG);

  10. change in fasting glucose (Time Frame: 6 and 12 months after index CAG);

  11. change in HbA1c (Time Frame: 6 and 12 months after index CAG)

  12. change in lipid profile (Time Frame: 1, 6 and 12 months after index CAG);

  13. change in high‐sensitivity C‐reactive protein(hs‐CRP) (Time Frame: 1 and 12 months after index CAG);

  14. safety endpoint: number of participants with abnormal laboratory values and adverse events (Time Frame: 1 and 12 months after index CAG).
Starting date July 12, 2017
Contact information Joo‐Yong Hahn, MD, PhD; 82‐2‐3410‐6653; ichjy1@gmail.com
Notes Location: Korea
Recruitment Status: Recruiting
Expected completion date: December 31, 2023