The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease

Phase 2

• Conditions: Coronary Syndrome
• Interventions: Drug: Rosuvastatin; Drug: Olmesartan; Drug: Combination; Drug: Placebo of Rosuvastatin; Drug: Placebo of Rosuvastatin/Olmesartan(Combination); Drug: Placebo of Olmesartan

• Registration Number: NCT02516826
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-08
• Study Start: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-04
• Last Update Submitted: 2015-08-04
• Study First Posted: 2015-08-06
• Last Update Posted: 2015-08-06
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 504

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin Arm	Rosuvastatin	Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Rosuvastatin Arm	Placebo of Rosuvastatin/Olmesartan(Combination)	Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Olmesartan Arm	Olmesartan	Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Olmesartan Arm	Placebo of Rosuvastatin	Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Olmesartan Arm	Placebo of Rosuvastatin/Olmesartan(Combination)	Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Combination Arm	Combination	Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
Combination Arm	Placebo of Olmesartan	Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
Rosuvastatin Arm	Placebo of Olmesartan	Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
Combination Arm	Placebo of Rosuvastatin	Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cardiac and Vascular Center; Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of