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

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Coronary Syndrome

Treatments: Drug: Placebo of Rosuvastatin; Drug: Rosuvastatin; Drug: Placebo of Rosuvastatin/Olmesartan(Combination); Drug: Combination; Drug: Placebo of Olmesartan; Drug: Olmesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT02516826

2015-01-055

Details and patient eligibility

About

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.

Enrollment: 504 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

504 participants in 3 patient groups

Rosuvastatin Arm

Experimental group

Description:

Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily

Treatment:

Drug: Placebo of Olmesartan

Drug: Placebo of Rosuvastatin/Olmesartan(Combination)

Drug: Rosuvastatin

Olmesartan Arm

Experimental group

Description:

Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily

Treatment:

Drug: Olmesartan

Drug: Placebo of Rosuvastatin/Olmesartan(Combination)

Drug: Placebo of Rosuvastatin

Combination Arm

Experimental group

Description:

Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg

Treatment:

Drug: Placebo of Olmesartan

Drug: Combination

Drug: Placebo of Rosuvastatin