NCT02516826

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

The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Rosuvastatin
DRUG	Olmesartan
DRUG	Combination	Rosuvastatin/Olmesartan(Combination)
DRUG	Placebo of Rosuvastatin
DRUG	Placebo of Olmesartan
DRUG	Placebo of Rosuvastatin/Olmesartan(Combination)

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2015-08-06
• Last updated: 2015-08-06

Locations

1 site across 1 country: South Korea