drugset / Trial / NCT02516826

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

NCT02516826

Phase 2 Unknown 504 enrolled Samsung Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2015-08
Primary completion
2018-08
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Olmesartan Other / unclassified 20 mg Oral
Subject Rosuvastatin Small molecule 10 mg Oral