The Effect of Rosuvastatin and Olmesartan on the Progression of Coronary Atherosclerotic Disease by Smart Angioplasty Research Team: SMART-ROAD Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries
研究概览
简要总结
- 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.
- 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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be at 19 years~70 years of age
- •Patients undergoing coronary CTA with coronary artery stenosis 30~70%
- •Informed consent
- •Appropriate CT resolution enough to measure of plaque volume
- •Patients who are stain and renin-angiotensin system blocker naïve at least for 1 year
排除标准
- •Patients with>=70% luminal stenosis or requiring percutaneous coronary intervention(PCI)
- •Severely calcifiedcoronary artery
- •Patients who have a history of previous PCI or coronary artery bypass grafting surgery.
研究组 & 干预措施
Rosuvastatin Arm
Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
干预措施: Rosuvastatin (Drug)
Rosuvastatin Arm
Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
干预措施: Placebo of Olmesartan (Drug)
Rosuvastatin Arm
Rosuvastatin 10mg in combination with placebo of Olmesartan 20mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
干预措施: Placebo of Rosuvastatin/Olmesartan(Combination) (Drug)
Olmesartan Arm
Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
干预措施: Olmesartan (Drug)
Olmesartan Arm
Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
干预措施: Placebo of Rosuvastatin (Drug)
Olmesartan Arm
Olmesartan 20mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan/Rosuvastatin(Combination) 20/10mg orally once daily
干预措施: Placebo of Rosuvastatin/Olmesartan(Combination) (Drug)
Combination Arm
Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
干预措施: Combination (Drug)
Combination Arm
Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
干预措施: Placebo of Rosuvastatin (Drug)
Combination Arm
Olmesartan/Rosuvastatin(Combination) 20/10mg in combination with placebo of Rosuvastatin 10mg plus placebo of Olmesartan 20mg
干预措施: Placebo of Olmesartan (Drug)
结局指标
主要结局
PAV(nominal change of percent atheroma volume) in the proximal to mid segments of major epicardial coronary arteries
时间窗: 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)
次要结局
- TAV (nominal change of total atheroma volume) in the proximal to mid segments of major epicardial coronary arteries(Over the 48weeks)
- 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)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center