Coronary Syndrome
Conditions
Brief summary
1. Stains have demonstrated consistent benefits to reduce cardiovascular events in several primary and secondary prevention trials. The suppression of plaque progression or regression may be a part of mechanism of clinical benefit. The intravascular ultrasound studies demonstrated that intensive statin therapy can regress or inhibit the progression of coronary atherosclerosis. 2. Unregulated renin-angiotensin system is important in the pathogenesis of cardiovascular disease. Angiotensin receptor antagonists (ARB) have been reported to improve clinical outcomes in patients with heart failure, left ventricular dysfunction, myocardial infarction, and high-risk patients. Several small studies showed that ARBs were effective to inhibit the progression of coronary atherosclerosis by intravascular ultrasound examination. 3. The combined therapy with statins and ARBs may be additive or synergistic effects on the atherosclerosis regression as well as to improve endothelial dysfunction and insulin resistance in addition to lowering cholesterol levels and blood pressure when compared with either monotherapy in patients. 4. Serial computed tomography angiography (CTA) can be utilized to assess the effect of treatment on coronary plaque morphology. In addition to the assessment of luminal stenosis, CTA also allows characterization of plaque morphology.
Interventions
DRUGRosuvastatin
DRUGOlmesartan
DRUGCombination
Rosuvastatin/Olmesartan(Combination)
DRUGPlacebo of Rosuvastatin
DRUGPlacebo of Rosuvastatin/Olmesartan(Combination)
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at 19 years\ 70 years of age 2. Patients undergoing coronary CTA with coronary artery stenosis 30\ 70% 3. Informed consent 4. Appropriate CT resolution enough to measure of plaque volume 5. Patients who are stain and renin-angiotensin system blocker naïve at least for 1 year
Exclusion criteria
1. Patients with\>=70% luminal stenosis or requiring percutaneous coronary intervention(PCI) 2. Severely calcifiedcoronary artery 3. Patients who have a history of previous PCI or coronary artery bypass grafting surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries | Over the 48weeks | Left main, LAD proximal to mid (from ostium to a large second diagonal branch), LCX proximal (from ostium to a large first obtuse marginal branch), RCA (from ostium to a distal bifurcation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries | Over the 48weeks | Left main, LAD proximal to mid (from ostium to a large second diagonal branch), LCX proximal (from ostium to a large first obtuse marginal branch), RCA (from ostium to a distal bifurcation) |
| LAPV (nominal change of percent low attenuation plaque volume) | Over the 48weeks | — |
| Nominal change of atheroma volume in 10 mm subsegment with greatest disease severity | Over the 48weeks | — |
| Change in insulin resistance | Over the 48weeks | — |
| Major adverse cardiac events | Over the 48weeks | — |
Countries
South Korea
Contacts
Primary ContactHyeon-Cheol Gwon, PhD
Backup ContactYoung Bin Song, PhD
Outcome results
None listed